Royal Decree 3349/1983 of 30 November adopted the Technical-Health Regulations for the manufacture, marketing and use of pesticides, establishing as the object of the standard the technical and health (a) products in respect of public health, as well as the setting of requirements for the manufacture, placing on the market and use of pesticides, and the establishment of the bases for the fixing of their maximum residue limits, all of which in order to prevent accidents and poisonings and to prevent or limit hazards associated with its direct and indirect use.

Also regulated the approval of the different types of pesticides, which should continue to be registered in their respective Official Records: plant protection products as well as pesticides for livestock use, in the Ministry of Agriculture, Fisheries and Food, and those of use in the food and environmental industries as well as those of use in personal hygiene and the disinfectants of clinical and pharmaceutical materials and of clinical and surgical environments, in the Ministry of Health and Consumer Affairs.

For the registration of the pesticides in their respective Official Records, the aforementioned Royal Decree establishes that, as a prerequisite, their aspects of danger to human health are to be approved in accordance with the provisions The Commission shall, in accordance with the provisions of this Regulation, make it possible to determine, among other aspects, its classification, the symbols and phrases of risk to be included in the labelling, and the acceptability of their use for domestic use.

By Royal Decree 162/1991 of 8 February, the Technical-Health Regulations for the manufacture, placing on the market and use of pesticides were amended in order to transpose the provisions of the Directive. 78 /631/EEC of 26 June concerning the classification, packaging and labelling of dangerous preparations (pesticides), introducing certain criteria for the classification of preparations of a non-chemical nature and giving the Ministry of Health and Consumer Affairs the competence to promote the initiation of files to suspend or limit the placing on the market of preparations when it is found to be a hazard to human health or safety.

Likewise, Royal Decree 443/1994 of 30 March, once again modified the aforementioned technical-health regulations, in order to include pesticides of use in the food industry among those that should register in the Register of the Directorate General of Public Health.

The classification and identification of the hazards and risks of each substance and preparation must also be carried out in accordance with the provisions of Royal Decree 363/1995 of 10 March 1995 on classification, packaging and labelling of dangerous substances, Royal Decree 1078/1993 of 2 July 1993 on dangerous preparations, Council Regulation (EEC) No 793/1993 on the assessment and control of the risks of existing substances and Royal Decree 1406/1989 of 10 December 1989. November, imposing limitations on the marketing and use of certain substances and dangerous preparations, with the Directorate-General of Public Health being the competent authority in this field.

For its part, the Royal Decree 1415/2000, of July 21, establishes, in its article 11, that the Directorate General of Quality and Environmental Assessment of the Ministry of Environment will be the competent authority for the environmental.

Subsequently, the publication of Directive 98 /8/EC of the European Parliament and of the Council of 16 February concerning the placing of biocidal products on the market harmonises at European level the legislation on these products, known as non-agricultural pesticides. These biocidal products are necessary for the control of organisms harmful to human and animal health and for the control of organisms harmful to natural or manufactured products.

In addition, on 7 September 2000, Commission Regulation (EC) No 1896/2000 was adopted, which sets in motion the first phase of the programme referred to in Article 16.2 of that Directive.

In order to achieve, among other objectives, the free movement of such products on the Community territory, while ensuring a high level of protection of human health, animal health and the environment, Directive lays down the procedures for authorisation and registration, as well as a basic set of common data for biocidal substances and preparations. These common principles of evaluation shall be aimed at avoiding risks to human health and the environment through epidemiological control, mutual recognition among Member States, the drawing up of a Community list of active substances authorised as ingredients of biocidal products, a system for the exchange of technical and administrative information between the competent authorities, as well as a Community procedure for the inclusion of substances in the list, other aspects, contributing to the reduction of the number of animal and animal tests to a minimum ensuring that authorised biocidal products, when properly used for the intended purpose, are sufficiently effective and do not have unacceptable effects on the organisms to which they are intended.

In order to comply with the principles of operation that must govern the action of the General Administration of the State, in accordance with Article 3 of Law 6/1997 of 14 April of the Organization and Operation of the General Administration of the State, in particular, the effectiveness of the objectives, efficiency in the allocation and use of public resources, the streamlining and the agility of the administrative procedures, and effective service to citizens, as well as to facilitate the management of the Directive, The registration of the different types of biocidal products should be recast in a single register.

At present, a large part of these activities are developed by the Directorate General of Public Health as a management centre responsible for the management of state functions in public health, in particular the activities of the public health authorities. Specific records of Public Health Pesticides and New Substances Notification, as well as the related activities, in particular those relating to the assessment of hazard and risk and classification and labelling for human health.

In the same way, it develops the exclusive competence of the State in relation to dangerous preparations, limitation and prohibition of placing on the market of dangerous substances and risk assessment for substances existing marketed. It is also assigned the functions on the regulation of the health control of chemicals and the management of the environmental monitoring network.

By this Royal Decree, Directive 98 /8/EC is incorporated into our national law, with the exception of the establishment of a system of fees, which must be subject to regulation, in its essential elements, by means of a rule of law, in compliance with the principle of legality in this matter established in the Constitution.

This Royal Decree has the character of a basic rule and is dictated under the terms of Article 149.1.16. and 23. of the Constitution and in accordance with the provisions of Article 40 (1), (2), (5) and (6) of Law 14/1986 of 25 April, General of Health.

In the preparation of this provision have been heard the Autonomous Communities, as well as the sectors affected and has issued its mandatory report the Inter-Ministerial Commission for Food Management.

In its virtue, on the proposal of the Minister of Health and Consumer Affairs and of the Ministers of Agriculture, Fisheries and Food and Environment, after the approval of the Minister of Public Administration, according to the State Council and after deliberation by the Council of Ministers at its meeting on 11 October 2002,

D I S P O N G O:

Article 1. Object and scope of application.

1. This Royal Decree is intended to regulate:

(a) The requirements for the authorisation and placing on the market of biocidal products on Spanish territory.

(b) The assessment of the hazard and risk of biocidal products.

(c) The rules for the mutual recognition of authorisations and records of biocidal products on the territory of the European Union.

(d) The rules for the preparation of the positive list of active substances that may be used in biocidal products.

2. This provision shall apply to biocidal products as defined in Article 2 (a). The following aspects shall be excluded from the scope of this Royal Decree, which shall be governed by their specific rules, as the products defined or falling within the scope of that specific legislation:

a) Medicines for human use.

b) Medicinal products for veterinary use.

c) Health products and active implantable medical devices. As well as "in vitro" diagnostic medical devices.

d) Flavourings for food products and basic materials for their production.

e) Food additives authorised in foodstuffs intended for human consumption.

f) Materials and objects intended to come into contact with food products.

g) Raw milk, heat-treated milk and dairy products.

(h) The hygienic and sanitary standards relating to the production and placing on the market of egg products.

i) The health rules applicable to the production and placing on the market of fishery products.

(j) Products used in animal feed, feed and medicated feed.

k) Cosmetic products.

l) Plant protection products.

m) The conditions for granting temporary and limited derogations from the specific Community health rules applicable to the production and marketing of certain products of animal origin.

3. This Royal Decree shall apply without prejudice to the relevant provisions or measures taken pursuant to those provisions, in particular those relating to:

(a) The limitation to the placing on the market and use of certain dangerous substances and preparations.

(b) The prohibition on the placing on the market and use of plant protection products containing certain active substances.

c) The export and import of certain hazardous chemicals.

d) The protection of workers against the risks related to exposure to chemical, physical and biological agents during work. The implementation of measures to promote the improvement of the safety and health of workers in the workplace.

e) Misleading advertising.

4. This Royal Decree obliges manufacturers, importers, formulators, marketing companies and companies of biocidal products to be determined, as such, to be understood as such, any natural or legal person who carries out application services for these products.

5. The provisions of Article 19 shall not apply to the carriage of biocidal products by train, roads, waterways, sea or air.

Article 2. Definitions.

For the purposes of this Royal Decree is understood by:

(a) Biocides: active substances and preparations containing one or more active substances, presented in the form in which they are supplied to the user, intended to destroy, counteract, neutralise, prevent action or to exercise a control of another type over any harmful organism by chemical or biological means. An exhaustive list of 23 product types and, within each product type, a series of indicative descriptions, is given in Annex

.

(b) Low-risk biocidal products: biocidal products containing only one or more of the substances listed in Annex IA and containing no substance of possible risk. Under conditions of use, the biocidal product shall only pose a low risk to humans, animals and the environment.

(c) Basic substances: substances which are classified in Annex IB and whose main use is not as pesticides but which are of minor use as biocides, either directly or in a product formed by the a substance and a simple diluent other than, in turn, a substance of possible risk and not directly marketed for use as a biocidal product.

(d) Active substance: a substance or a micro-organism, including a virus or a fungus, which exercises general or specific action against harmful organisms.

(e) Substance of possible risk: any substance other than the active substance, which has the intrinsic capacity to produce adverse effects in humans, animals or the environment, and is present or produced in a a concentration sufficient to manifest this effect. This type of substance, unless it presents other possible risks, must be classified as dangerous, in accordance with Royal Decree 363/1995, and be present in the biocidal product at such a concentration that the product should be considered dangerous, according to Royal Decree 1078/1993.

(f) Harmful Organism: any organism whose presence is undesirable or which has a harmful effect on the human being, its activities or the products it uses or produces, or on animals, or the environment.

(g) Waste: one or more of the substances present in a biocidal product constituting the remains of their use, including the metabolites of those substances and the products resulting from their degradation or reaction.

(h) Marketing: any supply, whether for consideration or free of charge, or subsequent storage other than storage followed by the issue outside the customs territory of the European Union or its disposal. The importation of a biocidal product into the customs territory of the European Union shall be considered as a marketing for the purposes of this Royal Decree.

(i) Authorisation: the administrative act whereby, upon submission of an application by the person concerned to the competent authority, the placing on the market of a biocidal product is authorised.

j) Framework form: specifications for a group of biocidal products intended for the same use and type of user. That group of products shall contain the same active substances with the same specifications, and their composition shall only present variations in respect of a previously authorised biocidal product, which do not affect the risk level of those products. or its effectiveness. Variation shall mean the tolerance of a reduction in the percentage of the active substance, and/or an alteration of the percentage composition of one or more non-active substances and/or the replacement of one or more pigments, dyes or flavourings by other substances. they have equal or lower risk and do not decrease their effectiveness.

(k) Registration: the administrative act by which the person concerned has submitted an application to the competent authority, and after verification by reason of the fact that the file complies with the relevant requirements of this Royal Decree, the placing on the market of a low-risk biocidal product is authorised.

l) Letter of access: a document signed by the owner or the owners of the relevant data, protected by virtue of what is established in this Royal Decree, in which it is stated that such data may be used by the competent authority for the purposes of granting an authorisation or a register of the biocidal product.

m) Adjuvant: substances such as surfactants, fluidifiers, stabilizers and other substances which are useful in the manufacture of biocidal products for their capacity to modify the physical and chemical properties of the products active ingredients.

n) Substances: the chemical elements and their compounds in the natural state, or those obtained by any production process, including the additives necessary to preserve the stability of the product and the impurities result from the procedure used, excluding solvents that can be separated without affecting stability or modifying the composition.

n) Prepared: mixtures or solutions composed of two or more substances.

o) Scientific research and development: chemical research, analysis and scientific experiments carried out under controlled conditions. This definition includes the determination of intrinsic properties, performance and effectiveness, as well as scientific research related to product development.

p) Research and development of production: the further development of a substance during which its application areas are tested, using pilot production or production tests.

Article 3. Authorisation to place biocidal products on the market.

1. Biocidal products may only be placed on the market and used in the national territory if they have been previously authorised and entered in the Official Register of Biocidal Products of the Directorate-General for Public Health of the Ministry of Health and Consumer Affairs, Article 26 of this Royal Decree.

2. By way of derogation from the above paragraph:

(a) Low-risk biocidal products may be placed on the market and used after submission to the Directorate-General for Public Health of a dossier, in accordance with Article 8.4, provided that they are duly registered, in accordance with Article 26 of this Royal Decree.

(b) Basic substances may be placed on the market and used as biocidal products where they have been introduced in Annex IB.

3. Request resolution deadlines:

(a) In the procedures relating to applications for authorisation, the Directorate-General for Public Health shall issue a decision and notify the person concerned within a period of six months. As for the procedure, the provisions of Law 30/1992, of 20 November, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, as amended by Law 4/1999, of January 13, will be in place.

(b) For applications for biocidal products, which as a low risk require registration, the Directorate-General for Public Health shall have a period of 60 days to issue and notify the relevant resolution.

4. The Directorate-General for Public Health shall, on request or on its own initiative, and where relevant, establish a framework formulation, which shall be communicated to the applicant when granting an authorisation for a given biocidal product.

Subject to the provisions of Articles 8 and 12 of this Royal Decree and provided that the applicant has the right to access the framework formulation in the form of an access letter, when a subsequent application for authorisation for a The new biocidal product shall be based on that framework formulation, the Directorate-General for Public Health shall take a decision in this respect within 60 days.

5. Biocidal products shall be classified, packaged and labelled in accordance with this Royal Decree.

6. Without prejudice to Article 7 (1), a biocidal product shall be authorised for a maximum period of 10 years from the date of the first registration or re-registration of the active substance in Annex I or IA for this type of product. The period of authorisation shall not exceed the period laid down for the active substance in those Annexes. In the case of renewal of the authorisation of the biocidal product, it may be carried out after verifying that the conditions imposed by Article 5 (1) and (2) are still fulfilled.

The renewal, if appropriate, may be granted for the period of time necessary to enable the Directorate-General for Public Health to carry out the verification that these conditions are still being met.

7. Biocidal products shall be used in the appropriate manner, which shall mean that the conditions laid down in Article 5 and those specified in Article 19 are met as regards labelling. Such use shall entail the application of appropriate physical, biological, chemical or other measures which limit the use of biocidal products to the minimum necessary. Where biocidal products are used in the workplace, their use shall be made in accordance with the provisions of the rules on the protection of workers.

Article 4. Mutual recognition of authorizations and records.

1. Without prejudice to Article 12, a biocidal product which has been authorised or registered in a Member State shall be authorised or registered before the end of one hundred and twenty days or sixty days, respectively, from the date of receipt of the application in Spain, provided that the active substance of the biocidal product is included in Annexes I or IA and complies with the requirements of those Annexes.

In the case of mutual recognition of authorisations, the application shall include a summary of the dossier, in accordance with the provisions of Article 8 (3) (a) and Section X of Annex IIB or Section X of the Annex IVB, as applicable, as well as a legalised copy of the first authorisation granted.

For the mutual recognition of records of low-risk biocidal products, the application shall include the requirements laid down in Article 8 (4), except as regards the efficacy data, for which it shall be sufficient. a summary; a legalised copy of the first record granted shall be required.

If the application concerns biocides for livestock use, it shall be submitted, with the documentation submitted, to the General Directorate of Livestock, for the purpose of its study and assessment.

The authorisation may also be subject to provisions arising from the application of other measures laid down in the rules relating to the conditions for the distribution and use of biocidal products, intended to protect the health of the distributors, users and workers concerned.

This mutual recognition procedure is without prejudice to the provisions of legal provisions designed to protect the health of workers.

2. If, in accordance with Article 5, the Directorate-General for Public Health determines that:

(a) The species to which the biocidal product is intended is not present in harmful quantities,

b) An unacceptable tolerance or resistance of the organism to which the biocidal product is intended is demonstrated, or

(c) The relevant circumstances concerning the use of the biocidal product, such as the climate or the period of reproduction of the species to which it is intended, differ significantly from those of the Member State in which it was authorised or registered. for the first time the biocidal product, and if its unmodified authorisation may therefore present unacceptable risks to the human or the environment, may require that the conditions referred to in paragraphs (e), (f), (h), (j) and (l) of the Article 19 (2) for the different circumstances, so that the requirements of the Article 5.

3. The Directorate-General for Public Health may, on a provisional basis, refuse to register a biocidal product registered by another Member State if it does not comply with the definition laid down in Article 2 (b) and shall immediately communicate it to the authority. competent authority of that Member State. If, within the maximum period of 90 days, no agreement has been reached between the authorities concerned, the matter shall be referred to the Commission for a decision in accordance with the procedure laid down in

following paragraph.

4. By way of derogation from paragraphs 2 and 3 of this Article, where the Directorate-General for Public Health considers that a biocidal product authorised by another Member State cannot fulfil the conditions laid down in Article 5 (1), and therefore, it is proposed to refuse authorisation or registration or to establish limitations to the authorisation, it shall notify the other Member States, the Commission and the applicant. It shall also provide them with an explanatory document containing the name and specifications of the product and the reasons for which it is proposed to refuse authorisation or to limit the authorisation.

5. If the procedure in paragraph 4 leads to confirmation or refusal of approval or registration by the competent Community bodies at the level of the European Union, a decision shall be taken by the Directorate-General for Public Health confirming or rejecting the authorisation or registration in accordance with the decision taken by those Community bodies and, where appropriate, shall review their registration in accordance with Article 6.

6. By way of derogation from paragraph 1 of this Article, the Directorate-General for Public Health may reject, if its decision is justified, the mutual recognition of authorisations granted for biocidal products of product-types 15, 17 and 23 of the Annex V to this Royal Decree and shall inform the other Member States and the Commission of its decision.

Article 5. Conditions for granting an authorization.

1. The Directorate-General for Public Health shall authorise or register a biocidal product and enter it in the Official Register of Biocidal Products when:

(a) The active substance (s) in the substance (s) included in the lists in Annex I or IA and all the requirements laid down in the Annexes are met;

(b) In the light of current scientific and technical knowledge and as a result of the examination of the dossier referred to in Article 8 and in accordance with the principles of assessment set out in Annex VI and taking into account account: All normal conditions of use of the biocidal product, the use of the material treated with it, and the consequences of use and disposal.

The biocidal product:

1. º is effective enough.

2. No unacceptable effects on the organisms to which it is intended, such as unacceptable resistance, or cross-resistance, or unnecessary suffering and pain for vertebrates.

3. No unacceptable effects, by itself or as a consequence of their residues, on human health

or animal, directly or indirectly (for example, drinking water or food intended for human or animal consumption, indoor air or workplace consequences), or in surface and groundwater.

4. No unacceptable effects on its own or as a result of its residues in the environment, taking into account its destination and distribution, in particular the contamination of surface water (including marine and estuary waters), drinking water and groundwater, and their impact on organisms other than those to which they are intended.

(c) It is possible to determine the nature and quantity of its active substances and, where appropriate, any toxicological or ecotoxicologically significant impurity or adjuvant, as well as its residues of toxicological or environmental importance resulting from the authorised uses, in accordance with the relevant requirements of Annexes IIA, IIB, IIIA, IIIB, IVA or IVB;

(d) Their physical and chemical properties have been determined and are considered acceptable for the purpose of proper use, storage and transport of the product;

e) It has been previously assessed, as far as environmental aspects are concerned, by the Environment Ministry's Directorate-General for Quality and Environmental Assessment, and there is a favourable report on this;

(f) Exist a favourable report from the Directorate-General for Pharmacy and Health Products of the Ministry of Health and Consumer Affairs, in the case of biocidal products intended to be applied on the human body and in the health area;

g) Exists a mandatory and binding report from the Directorate General of Livestock, Ministry of Agriculture, Fisheries and Food in the case of biocidal products for uses between which the farmer is included.

2. A biocidal product classified within the meaning of Article 19 (1) as toxic, highly toxic or as carcinogenic or mutagenic, category 1 or 2 or toxic for reproduction category 1 or 2, shall not be authorised for the placing on the market or use by the public in general.

3. Where an authorisation is issued, account shall be taken of the requirements laid down in other rules or provisions affecting the conditions for the authorisation and use of the biocidal product and, in particular, those intended to protect the health of the distributors, users, workers and consumers, that of animals, or the environment.

4. The authorisation or registration and registration in the Official Register of Biocidal Products shall be subject to compliance with the requirements laid down in paragraph 1 of this Article and shall determine the conditions for placing on the market and use necessary for ensure compliance.

Article 6. Review of an authorization.

Any authorisation may be reviewed at any time, for example in the light of new information received in accordance with Article 14, where there are indications that the conditions laid down in the Article are no longer met. 5. In this case, the necessary additional information may be required from the holder of the authorisation or the applicant to whom a modification of the authorisation would have been granted, in accordance with the provisions of Article 7.

If necessary, the authorization to complete the review as well as to provide additional information should be extended.

Article 7. Revoking or modifying an authorization.

1. An authorization will be revoked if:

(a) The active substance is no longer included in Annex I or IA in accordance with Article 5 (1) (a).

(b) The conditions of Article 5 (1) are no longer fulfilled.

c) It is discovered that the information under which the authorization was granted contains false or misleading elements.

d) The holder of the authorization so requests and indicates the reasons for the revocation.

2. Where the Directorate-General for Public Health considers it necessary to revoke an authorisation, it shall inform the holder thereof and open a hearing period. Also, without prejudice to the provisions of Royal Decree 1406/1989 of 10 November 1989 imposing restrictions on the marketing and use of certain dangerous substances and preparations and in paragraph 1 (a) of this Regulation, It may be granted for disposal or for the storage, placing on the market and use of the stocks of the product, a period of time, the duration of which will depend on the reason for the revocation.

3. In the light of developments in scientific and technical knowledge and in order to protect human health, the Directorate-General for Public Health may, where it considers necessary, amend the conditions for the use of an authorisation, and in particular: the form of use or the quantities to be used, shall inform the holder thereof and open a period of hearing.

An authorization may also be modified if the holder of the authorization so requests and indicates the reasons for the modification.

4. When the Directorate-General for Quality and Environmental Assessment considers it necessary in the field of its competences, according to the evolution of scientific and technical knowledge and in order to protect the environment, to revoke or modify the conditions If an authorisation is used, it shall be notified to the Directorate-General of Public Health, who shall inform the holder of the authorisation and open a period of hearing.

5. Where the proposed amendment relates to an extension of the use, the Directorate-General for Public Health shall extend the authorisation under the specific conditions to which the active substance is submitted in accordance with Annexes I or II. AI.

6. Where the proposed amendment of an authorisation involves changes in the particular conditions to which the active substance is subject in Annex I or IA, such changes shall only be made after the assessment of the active substance in respect of the proposed changes, in accordance with the procedures laid down in Article 11.

7. Where the Directorate-General for Pharmacy and Health Products or the Directorate-General for Livestock considers it necessary in the field of its competence, in accordance with the development of scientific and technical knowledge, to revoke or amend the conditions The Commission shall inform the Directorate-General of Public Health, who shall inform the holder of the authorization, of the use of an authorization and shall open a hearing. Likewise, in the modifications or revocations of the authorized products, which were informed by the Directorate General of Pharmacy and Sanitary Products or by the General Directorate of Livestock, it will be necessary to also count on the the mandatory reporting of these management centres in relation to the proposed modification or revocation.

8. Amendments shall be granted only if the conditions laid down in Article 5 have been found to continue to be fulfilled.

Article 8. Requirements for authorization and registration.

1. The application for authorisation shall be made by or on behalf of the person responsible for the first placing on the market of a biocidal product and shall be addressed to the Directorate-General for Public Health.

2. Applicants shall have a permanent office in a country of the European Union.

3. The applicant for an authorisation shall present:

(a) A dossier or a letter of access to the biocidal product which, in accordance with the scientific and technical knowledge of the moment, meets the requirements of Annex IVB or Annex IIB and, where specified, to the parties relevant to Annex IIIB, and (b) For each of the active substances of the biocidal product, a dossier or an access letter which meets the requirements of Annex IVA or Annex IIA and, where specified, to the relevant parts of Annex IIIA.

4. By way of derogation from paragraph 3 (a), a dossier shall be submitted for a low-risk biocidal product with the following data:

(a) Applicant: Name, surname and address, manufacturers of the biocidal product and active substances (names and addresses, including the manufacturer's seat of the active substance), where appropriate, a letter of access to all data required.

b) Denomination and composition of the biocidal product:

Trade name, full composition, physical and chemical properties referred to in Article 5 (1) (d).

c) Expected uses: Type of product according to Annex V of this Royal Decree and scope of use, category of users, method of use.

d) Data on effectiveness.

e) Analytical methods.

(f) Classification, packaging and labelling, including a draft label, in accordance with Article 19 of this provision.

g) Safety data sheet as set out in Royal Decree 1078/1993 or Royal Decree 363/1995.

5. The technical files shall be forwarded to the Directorate-General for Public Health and shall include a complete and detailed description of the studies carried out and the methods used, or a bibliographic reference thereof and contain the information and the results of the studies referred to in Annexes IVA and IVB or in Annexes IIA and IIB and, where specified, in the relevant parts of Annexes IIIA and IIIB.

The information provided in accordance with paragraph 3 of this Article shall be sufficient to make an assessment of the effects and properties referred to in paragraph 1 (b), (c) and (d). of Article 5.

6. Information shall not have to be provided where it is not necessary for the nature of the biocidal product or uses for which it is intended, or where it is scientifically or technically not possible to facilitate it, in such cases, a justification for the Directorate-General for Public Health, as could be the existence of a framework formulation that the applicant has the right to know.

7. If, after the assessment of the dossier, further information, including data and results from complementary tests, is considered necessary to assess the hazards of the biocidal product, the applicant shall be required to provide such information. The calculation of the maximum period of the procedure shall be suspended until the date on which the requested information is received.

8. The name of the active substance shall be in accordance with the names set out in Annex I to the Regulation on the Notification of New Substances and Classification, Packaging and Labelling of Dangerous Substances, approved by the Royal Decree 363/1995 of 10 May. Where the substances are not included in that Annex, they shall be in accordance with the European Inventory of Existing Marketed Chemical Substances (EINECS). If they are not included in it, they shall be given the common name of the International Organisation for Standardisation (ISO). If the substances are not included in the substances, they shall be designated by their chemical name in accordance with the rules of the International Union of Pure and Applied Chemistry (IUPAC).

9. The tests will be carried out in accordance with the provisions of Royal Decree 822/1993 of 28 May 1993 laying down the principles of good laboratory practice and Royal Decree 223/1988 of 14 March 1988 on the protection of animals used for experimental and other scientific purposes and in accordance with the methods set out in Annex V to the Regulation on the Notification of New Substances and Classification, Packaging and Labelling of Dangerous Substances, approved by the Royal Decree 363/1995, dated May 10.

In the event that a method is not appropriate or is not described, other internationally recognized and justified methods will be used.

10. However, where there is data prior to 14 May 2000 and other than those set out in Annex V to Royal Decree 363/1995, the Directorate-General for Public Health in coordination with the Directorate-General for Quality and Evaluation Environmental, decide, on a case by case basis, whether the data are relevant for the purposes of this Royal Decree and whether further testing is necessary in accordance with the previous paragraph, taking into account, among other factors, the need to reduce the Minimum tests carried out on vertebrate animals.

11. The Directorate-General for Public Health shall open an administrative file for each application which shall contain at least a copy of the application, a record of the administrative decisions relating thereto and the files submitted under the paragraph 3 of this article, together with a summary of the latter.

The Directorate-General for Public Health, at the request of the competent authorities of the Member States and the Commission, shall provide these administrative files referred to in this paragraph, as well as any information necessary for the full understanding of the applications and, if requested, shall ensure that the applicants provide a copy of the technical documentation provided for in paragraph 3 of this Article.

12. Applications submitted in accordance with the provisions of this Royal Decree shall be drawn up, at least, in the official Spanish language of the State.

Article 9. Marketing of active substances.

Active substances for use in biocidal products may only be marketed when:

(a) A dossier has been submitted with the active substance not previously marketed at 14

May 2000, which satisfies the requirements of Article 11 (1) and is accompanied by a declaration that the same is intended to be part of a biocidal product. These requirements shall not apply to substances intended for use in research and development in accordance with Article 16.

(b) Stated, packaged and labelled in accordance with the provisions of the Regulation on the Notification of New Substances and Classification, Packaging and Labelling of Dangerous Substances, approved by Royal Decree 363/1995, of 10 May.

Article 10. Inclusion of an active substance in Annex I, IA or IB.

1. An active substance shall be included in Annexes I, IA or IB for an initial period not exceeding 10 years, when:

(a) biocidal products containing that active substance,

(b) low-risk biocidal products as defined in Article 2 (b),

(c) the substances defined in Article 2 (c), comply with the conditions of Article 5 (1) (b), (c), (d) and (e), taking into account the scientific and technical knowledge of the time and, where the cumulative effects resulting from the use of biocidal products containing the same active substances.

2. An active substance may not be included in Annex IA where it is classified, under Royal Decree 363/1995, as a carcinogen, muffle, reproduction toxic, sensitising, or when bioaccumulate and not easily degraded.

Where necessary, the inclusion of active substances in Annex IA shall relate to the concentration intervals between which the substance may be used.

3. The inclusion of an active substance in Annex I, IA or IB shall be conditional, if applicable:

a) Requirements about:

1. º The minimum degree of purity of the active substance, 2. ° The nature and maximum content of certain impurities,

3. The type of product in which it can be used,

4. The mode and use area,

5. The designation of user categories (e.g., industrial, professional, or non-professional),

6. Other particular conditions resulting from the assessment of the information, in accordance with this Royal Decree.

b) Setting up:

1. An acceptable level of operator exposure (NAEO), if necessary,

2. ° When relevant, an acceptable daily intake (ADI) for the human being and a maximum residue limit (MRL),

3. Your destiny and behavior in the environment and its impact on the different organisms to which it is intended.

4. The inclusion of an active substance in Annex I, IA or IB shall be limited to those types of products referred to in Annex V to this provision, and for which data would have been submitted in accordance with Article 8.

5. The inclusion of an active substance in Annex I, IA or IB may be renewed, once or more, for periods not exceeding 10 years. The initial inclusion, as well as any renewal of inclusion, may be reviewed at any time when there are indications that any of the requirements referred to in paragraph 1 of this Article are no longer met. Where appropriate, the renewal may be granted only for the time necessary to carry out the review, upon request for renewal and shall be granted for a limited period to facilitate the new information provided for in paragraph 2 of the Article 11.

6. (a) the inclusion of an active substance in Annex I or, where appropriate, in Annexes IA or IB may be refused or withdrawn:

1. If the assessment of the active substance in accordance with Article 11 (2) shows that, under the normal conditions under which it can be used in authorised biocidal products, it continues to cause concern for health or the environment, and

2. No Yes in that Annex already exists for the same product type as another active substance which, according to scientific and technical knowledge, presents a significantly lower risk for health or the environment.

When a refusal or withdrawal is considered for this cause, an assessment of one or more alternative active substances shall be submitted demonstrating that they can be used with a similar effect in the body to which they are intended, without any practical or economic disadvantages that are important to the user and without an increased risk to health and the environment.

The assessment shall be disseminated in accordance with the procedure laid down in Article 11 (2

.

(b) The refusal or withdrawal of a substance listed in Annex I and where relevant to the Annexes IA or IB shall be performed under the following conditions:

1. The chemical diversity of the active substances must be adequate to minimise the occurrence of resistance in the body to which it is intended.

2. It shall apply only to active substances which, when used under normal conditions in authorised biocidal products, present a significantly different level of risk.

3. It shall apply only to active substances used in products of the same type.

4. º It should be applied only after allowing, if necessary, to acquire experience of its use in practice when it does not already exist.

(c) The decision to remove a substance from Annex I shall not have immediate effect but shall be delayed for up to a maximum of four years from the date of the decision.

Article 11. Procedure for the inclusion of an active substance in Annex I, IA or IB.

1. The Directorate-General for Public Health shall examine the inclusion, or subsequent amendments to such inclusion, of an active substance in Annex I, IA or IB, where:

a) An applicant has submitted:

1. A dossier on the active substance that meets the requirements of Annex IVA or Annex IIA and, where specified, the corresponding parts of Annex IIIA.

2. º A dossier at least one biocidal product containing the active substance that meets the requirements of Article 8, with the exception of paragraph 4.

b) Have verified the dossiers and consider that they comply with the requirements of Annexes IVA and IVB or those of Annexes IIA and IIB, as well as those of Annexes IIIA and IIIB where appropriate, accept such dossiers and authorise the applicant to send a summary thereof to the other Member States and to the Commission.

2. An assessment of the dossiers shall be made within 12 months of the acceptance of the dossiers and a copy shall be sent to the Commission, the other Member States and the applicant, together with a recommendation for the inclusion of the dossiers. active substance in Annex I, IA or IB, or other type of decision, for further processing.

If further information is deemed necessary for the evaluation of the dossiers to make a complete assessment, the applicant shall be required to provide such information. This period of 12 months shall be suspended from the date of issue of the requirement to the date on which the requested information is received.

The Directorate-General for Public Health shall inform the other Member States and the Commission at the same time as the applicant.

3. The Directorate-General for Public Health, once the dossiers have been received, may request the Commission, in a reasoned manner, to make the evaluation of the dossiers carried out by other Member States.

Article 12. Use of data held by the Directorate General of Public Health by other applicants.

1. No use shall be made of the information referred to in Article 8 of this Royal Decree, relating to an active principle, for the benefit of a second applicant or other subsequent applicant:

(a) Unless the second or subsequent applicant has a written authorisation in the form of an access letter of the first applicant, in order to be able to use such information, or (b) in the case of an active substance not marketed before 14 May 2000, until 15 years after the date of its first inclusion in Annexes I or IA, or

(c) in the case of an active substance, which is already marketed as of 14 May 2000, in which case:

1. The period of protection shall be ten years, from 14 May 2000, for any information submitted.

2. The protection period shall be ten years from the date of the inclusion of an active substance in Annex I or IA in the case of information submitted for the first time in support of the first inclusion in those Annexes. annexes, either of the active substance or of a new product type corresponding to that active substance.

(d) In the case of additional information submitted for the first time and relating to the amendment of the requirements for inclusion in Annexes I or IA, or to the maintenance of the inclusion in Annexes I or IA, the period of protection shall be five years from the date of receipt of the additional information, unless that period ends before the date set out in paragraphs (b) and (c) of paragraph 1, in which case it shall be extended in such a way as to provide for the period of protection of the reports end at the same time.

2. No use shall be made of the information referred to in Article 8 of this Royal Decree, concerning a biocidal product and a low-risk biocidal product, for the benefit of a second applicant or other subsequent applicant:

(a) unless the second or subsequent applicant has a written authorisation in the form of a letter of access by the first applicant to be able to use that information, or (b) in the case of biocidal products containing a substance which is not on the market before 14 May 2000, in which case the protection period shall be 10 years from the date of the first marketing authorisation in a Member State

or

(c) in the case of a biocidal product containing an active substance, which is already on the market as of 14 May 2000, in which case the protection period shall be:

1. 10 years, from the date mentioned above, for any information submitted in accordance with it, 2. 10 years, from the date of the inclusion of an active substance in Annex I or IA, in the case of information submitted for the first time in support of the first inclusion in the said Annexes, either of the active substance or of a new product type corresponding to that active substance;

(d) in the case of data submitted for the first time and affecting an amendment to the conditions of authorisation of a biocidal product or to the maintenance of the inclusion of an active substance in Annex I or IA, in which case the the protection period shall be five years from the date of receipt of the additional information; unless that period ends before the date set out in paragraphs (b) and (c), in which case it shall be extended to the same date as such periods.

3. The Directorate-General for Public Health may forward to the Commission and to the Member States the information referred to in paragraphs 1 and 2 of this Article for the purposes of Article 10 (6

.

Article 13. Cooperation in using the data for the second and subsequent authorization request.

1. In the case of a biocidal product which has already been authorised in accordance with Articles 3 and 5, and without prejudice to the requirements of Article 12, a second applicant or subsequent applicant may be accepted to refer to the data provided by the first applicant or subsequent applicants, provided that they demonstrate that the biocidal product is such and its active substances are the same as those authorised in the first place, including the degree of purity and the nature of the impurities.

2. By way of derogation from Article 8 (3

:

(a) The applicant for authorisation for a biocidal product, before carrying out tests on vertebrate animals, shall request information from the Directorate-General for Public Health on whether the biocidal product for which the application is to be submitted is similar to another biocidal product that has been authorised, and the name and address of the holder or holders of the prior authorisation or authorisations.

The request for information shall be accompanied by documents proving that the potential applicant intends to request an authorisation on his own account and that the rest of the information specified in the Article 8 (3).

(b) The Directorate-General for Public Health shall provide the name and address of the holder (s) of previous authorisations and shall communicate to them the name and address of the new applicant, after ensuring that he himself/herself intends to submit such a request.

The holder (s) of prior authorizations and the new applicant shall share, among them, the existing information. To this end, the Directorate-General for Public Health shall encourage the holders of such information to collaborate in the provision of the required data in order to avoid, if possible, the repetition of tests on vertebrate animals.

In case of disagreement, the Directorate-General for Public Health, in order to avoid a repeat of tests on vertebrate animals, may take measures that require them to share the information, while determining the the procedure for their use, taking into account the interests of the parties concerned.

Article 14. New information.

1. Any holder of an authorisation for a biocidal product shall, on his own initiative and under his responsibility, immediately notify the Directorate-General of Public Health in writing of the information he or she is aware of concerning an active substance or a the biocidal product containing the product and which may influence the continuity of the authorisation by notifying in particular the following:

New knowledge or information on the effects of the active substance or the biocidal product on the human or the environment, changes in the origin or composition of the active substance, changes in the composition of an active substance, biocide, the development of resistance, changes of administrative type or other aspects such as the type of packaging.

2. The Directorate-General for Public Health shall immediately inform the other Member States, the Commission and the national competent authorities of any information it receives concerning potentially dangerous effects on human health or the environment or the new composition of a biocidal product, its active substances, impurities, adjuvants or residues.

Article 15. Exceptions to the requirements for marketing.

1. By way of derogation from Articles 3 and 5, the Directorate-General for Public Health, after reporting the Directorates-General referred to in Article 5 (1) (e), (1) (f) and (g), may authorise, for a period not exceeding 120 days, the placing on the market of biocidal products that do not comply with the requirements of this Royal Decree, for controlled and limited use, if such a measure is necessary due to an unforeseen danger which cannot be controlled by other means, immediately to the other Member States and to the Commission of the measure taken and their justification. The Directorate-General for Public Health may extend the period referred to above or reiterate the measure taken, subject to the agreement of the competent Community bodies.

Also, at the request of the General Directorate of Livestock, the Directorate General of Public Health will authorize the biocidal products that are necessary in case of urgency.

2. By way of derogation from Article 5 (1) (a), and until an active substance is included in the Community List of Annexes I or IA, the Directorate-General for Public Health may authorise provisionally and for a period not exceeding the maximum more than three years, the placing on the market of a biocidal product containing an active substance not included in those Annexes, provided that it is an active substance not previously placed on the market as at 14 May 2000, the purpose of which is not research and scientific development and production processes. Such authorisation may be granted only if, following the assessment of the dossiers, in accordance with Article 11, the active substance is deemed to comply with the requirements of Article 10 and the biocidal product meets the conditions of paragraphs (b), (c), (d), (e) and (f) and (g) of Article 5 (1) and no other Member State, raises objections under paragraph 2 (c) of Article 17.

The Directorate-General for Public Health will revoke the provisional authorisation when the competent Community bodies decide that the objections raised, where appropriate, are well founded, either because the files are not or because the active substance does not meet the requirements specified in Article 10.

If the evaluation of the dossiers for the inclusion of the active substance in Annex I or IA has not been completed, the product may be provisionally authorised for inclusion in the Annex I or IA. period not exceeding one year, provided that the active substance complies with the requirements of Article 10, informing the other Member States and the Commission thereof.

Article 16. Research and development.

1. By way of derogation from Article 3, any test or experiment for the purpose of research and development involving the placing on the market of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product, cannot be performed unless:

(a) In the case of scientific research and development, any person concerned shall keep a record with the identity of the biocidal product or active substance, labelling particulars, quantities provided and the names and addresses of the those persons who receive the biocidal product or active substance, and all available data on the possible effects on human or animal health or the impact on the environment. This information must be made available to the Directorate-General for Public Health.

(b) In the case of research and development in production processes, the information requested in subparagraph (a) shall be notified to the Directorate-General of Public Health, both to carry out the marketing and to carry out the tests or experiments.

2. An unauthorised biocidal product or an active substance for the sole use in a biocidal product may not be placed on the market for research and development purposes where there is a release to the medium during the tests or experiments thereof, except where evaluated the data available to the Directorate General of Public Health, with the previous report of the Directorate General of Quality and Environmental Assessment and, where appropriate, the General Directorate of Livestock, for the aspects of their respective powers and, where necessary, the non-binding report of the Ministry of Science and Technology given an authorisation which limits the quantities to be used, the areas to be treated and adjusted to the additional conditions which have been adopted for this purpose.

3. Any experiment or test to be carried out on Spanish territory shall obtain the prior authorisation of the Directorate-General for Public Health.

If the proposed tests or experiments referred to in paragraphs 1 and 2 may have harmful effects on human or animal health or an influence

unacceptable to the environment, the Directorate-General for Public Health may prohibit or authorize them only under the conditions necessary to avoid such consequences.

4. Paragraph 2 of this Article shall not apply where the person concerned has been granted the right to carry out certain experiments and tests and the conditions under which they are to be carried out have been fixed.

5. The common criteria, in particular the maximum quantities of active substances or biocidal products which may be released during experiments and the minimum data to be submitted in accordance with paragraph 2 of this Article, shall be adopted at a level community.

Article 17. Functions of the competent authority.

It will be the functions of the Directorate General of Public Health:

1. Examine the information and documentation referred to in this Royal Decree, and may also:

(a) To collect from the applicant the tests and the additional information, if following the evaluation of the dossiers, further information is considered necessary to make a complete assessment of the dossiers.

(b) to request the administrative files referred to in Article 8 (11), as well as all the information necessary for the full understanding of the applications, including, if necessary, a copy of the technical documentation provided for in Article 8 (3).

(c) Require to provide samples of the preparation and its components, as well as samples, models or projects of the packaging, labels and leaflets.

2. To participate in the exchange of information between the Commission and the competent authorities of the Member States, communicating and reporting:

(a) Within one month, after the end of each quarter, of all biocidal products which have been authorised or registered or have been refused, modified, renewed or cancelled an authorisation or registration, indicating at least:

1. º The name or social name of the applicant or holder of the authorization or registration.

2. The Commercial Denomination of the Biocide.

3. The name and quantity of each active substance it contains, as well as the name and quantity of each of the hazardous substances and their classification.

4. º The type of product and use or uses for which you are authorized.

5. º The type of formulation.

6. The proposed residue limits that have been determined.

7. º The conditions of the authorization and, where applicable, the reasons for the modification or cancellation of an authorization.

8. º If the product is of a special type (for example, a product included in a frame formulation or low-risk biocide).

(b) When rejecting the mutual recognition of authorisations granted for product types 15, 17 and 23 of Annex V to this Royal Decree.

(c) Without undue delay, to the competent authority responsible for the assessment of the dossiers, as well as to the Commission and the other Member States, when it receives the summary of the dossiers pursuant to subparagraph (b) of the Article 11 (1) and Article 15 (2) and have legitimate grounds for believing that it is incomplete.

(d) Where, due to an unforeseen danger which cannot be controlled by other means, it authorises for a controlled and limited use, for a period not exceeding 120 days, the placing on the market of biocidal products which do not comply with the requirements of this Royal Decree.

e) An annual list of authorised or registered biocidal products, to the other Member States and to the Commission.

(f) On its action in this field, as well as on any poisoning due to biocidal products, after 14 May 2000, every three years to the Commission, before 30 November.

3. To inform the Commission, the competent authorities and the applicant when proposing to refuse authorisation or registration or to establish limitations to the authorisation in certain circumstances for a biocidal product authorised by another Member State in the terms set out in Article 4 (4).

4. Forward a copy of the administrative files after their acceptance to the Commission, the Member States and the applicant with the recommendations and decisions it considers appropriate.

5. Ensure the confidentiality of the data relating to the composition of the formulations of a product.

6. To obtain, if appropriate, the collaboration and advice of scientific experts and, where appropriate, to set up specialised working groups for the examination of the dossiers.

7. To ensure that an active substance is included in Annex I, IA or IB, for the purposes of granting, amending or cancelling, as appropriate, the authorisations or, where applicable, the records of biocidal products containing those active substances and complying with the requirements of this Regulation. the provisions of this Royal Decree.

8. Establish, where appropriate, standard models and systems of the corresponding applications for the submission of documents in the authorisation and registration file.

9. Coordinate the actions necessary to comply with the principles set out in this provision.

10. Develop the basic legislation aimed at the harmonisation of the health policy of the Autonomous Communities in the field of surveillance and control of biocidal products.

11. Send to the Directorates General of Quality and Environmental Assessment, Pharmacy and Health Products, and Livestock, the technical documentation necessary for the issuance of the corresponding reports, as well as any information that affect.

It will be the functions of the General Directorate of Quality and Environmental Assessment, and if any, of the Directorate General of Pharmacy and Health Products and of the General Directorate of Livestock, as specified in paragraphs 1.a) and b), 6, 7 and 10 of this article, in the field of their respective competencies, collaborating with the Directorate General of Public Health for the performance of the aforementioned functions.

The General Directorate of Livestock shall be the competent authority to carry out the safety and efficacy assessment of biocidal products for its competence.

Article 18. Confidentiality.

1. By way of derogation from the provisions of Law 38/1995 of 12 December 1995 on the right of access to information in the field of the environment, any applicant may indicate the information which may be considered commercially sensitive and the dissemination of which could cause commercial or industrial injury and which, therefore, wishes to be confidential in respect of any person other than the competent authority or the Commission. In each case a full justification will be required. Without prejudice to paragraph 3 of this Article and to the Royal Decrees 363/1995 and 1078/1993, the Directorate-General for Public Health shall take the necessary measures to ensure the confidentiality of the composition of the formulations of a product if requested by the applicant.

2. The Directorate-General for Public Health shall, upon receipt of the request, decide, on the basis of the documentary evidence submitted by the applicant, the information to be considered as confidential in accordance with paragraph 1.

The information deemed confidential by the Directorate-General for Public Health shall be treated as such by the other competent authorities of the Member States and the Commission. The Directorate-General for Public Health shall treat such information as confidential by the competent authorities of the Member States and the Commission as confidential.

3. Once the authorization has been granted, in no case will they be confidential:

a) The name and address of the requester.

(b) The name and address of the manufacturer of the biocidal product.

c) The name and address of the manufacturer of the active substance.

(d) The name and content of the substance or active substances in the biocidal product, or the name of the biocidal product.

e) the names of other substances which are considered to be dangerous in accordance with the provisions of Royal Decree 363/1995 and which contribute to the classification of the product.

(f) The physical and chemical data relating to the active substance and the biocidal product.

g) Any method used to render the active substance or the biocidal product harmless.

(h) The summary of the results of the tests required by Article 8 to determine the efficacy of the product or substance and its effects on humans, animals and the environment, as well as its ability to cause resistance, if any.

i) Recommended methods and precautions to reduce risks due to handling, storage, transportation, use, fire, and other risks.

j) The security data tokens.

k) The methods of analysis provided for in Article 5 (1) (c).

l) The methods of disposal of the product and its packaging.

m) The procedures to be followed and the measures to be taken in case of leakage or leakage.

n) First aid to be dispensed and the medical advice to be given in case of damage to persons.

If the applicant, manufacturer or importer of the biocidal product or active substance subsequently discloses information which was previously confidential, it shall inform the Directorate-General of Public Health.

Article 19. Classification, packaging and labelling of biocidal products.

1. Biocidal products shall be classified and packaged in accordance with the provisions of the Dangerous Preparations Regulation, approved by Royal Decree 1078/1993.

In addition, products which are within the scope of the general public and may be confused with food, drink or feed shall contain components which deter their consumption and are packaged in such a way as to minimise the possibility of of such confusion. This requirement may be required in the authorisation procedure for those other products for professional use, the characteristics of which need to be specified.

2. Biocidal products shall be labelled in accordance with the provisions of the Dangerous Preparations Regulation, approved by Royal Decree 1078/1993. The labels must not mislead or give an exaggerated image of the product, nor shall they mention, in any case, the "low-risk biocidal", "non-toxic", "harmless", or similar warnings. In addition, the label shall clearly and indelibly display the following:

a) Identity of all active substances and their concentration in metric units.

(b) Number of authorisation granted to the biocidal product by the Directorate-General for Public Health.

c) Type of preparation.

(d) Uses for which the biocidal product is authorised (e.g. wood protector, disinfection, surface biocide, anti-fouling, etc.).

e) Instructions for use and dosing, expressed in metric units, for each use contemplated in the terms of the authorization.

f) Details of probable, direct or indirect adverse effects, and instructions for first aid.

g) The phrase "Read the instructions attached before using the product", if accompanied by a package leaflet.

(h) Instructions for the safe disposal of the biocidal product and its packaging, including, where appropriate, any ban on the reuse of the packaging.

i) The number or designation of the batch of the preparation and the relevant expiry date for normal storage conditions.

j) The period of time required for the biocidal effect to occur, the interval to be observed between applications of the biocidal product, where applicable; the time interval to be observed between the application and the next use the treated product or the next access of the human or animals to the area affected by the biocidal treatment, where appropriate; including details of the means and the decontamination measures and the duration of the necessary ventilation of the animals; treated areas; details of how the equipment is properly cleaned; details of the preventive measures necessary during the use, storage and transport (e.g. personal protective clothing and equipment, fire protection measures, furniture protection, food or feed movement and instructions) to avoid the exposure of animals).

And, where applicable:

k) The categories of users to which the biocidal product is limited.

(l) Information of any specific hazard to the environment, in particular with regard to the protection of organisms other than the organism to which it is intended and to prevent water contamination.

m) In the case of microbiological biocides, the labelling requirements laid down in accordance with the provisions of Royal Decree 664/1997 of 12 May 1997 on the protection of workers against risks related to exposure to biological agents during work.

The Directorate-General for Public Health shall require that the requirements of subparagraph (a), (b), (d) and, where applicable, (g) and (k) are always indicated on the product label and allow the requirements of paragraphs (c), (e), (f), (h), (i), (j) and (l) of this paragraph are indicated elsewhere in the package or in an additional prospectus forming an integral part of the package, considering that this information is part of the label for the purposes of this Royal Decree.

3. Where a biocidal product identified as insecticide, acaricide, rodenticide, avicide and molluscicide is authorised in accordance with the provisions of this provision and is subject to classification, packaging and labelling in accordance with the Regulation Pesticides, approved by Royal Decree 3349/1983 and subsequent amendments, the Directorate General of Public Health may allow changes in the packaging and labelling of such a product which may be necessary as result of those provisions, provided that they do not conflict with the conditions of an authorisation issued in accordance with this Royal Decree.

4. The Directorate-General for Public Health may require that samples, models or projects be supplied to the packaging, labels and leaflets.

5. The labelling of biocidal products shall be expressed at least in the official Spanish language of the State.

Article 20. Security Data Tab.

To ensure a specific system of information enabling professional and industrial users of biocidal products and, where appropriate, other users, to take the necessary measures for the protection of human health and the environment As for hygiene and safety at the workplace, a safety data sheet shall be used for each marketed product to be provided by the manufacturers or those responsible for placing the product on the market. A copy of the same will be given to the Directorate General of Public Health, preferably by telematic means or in its defect in magnetic support. The Directorate-General for Public Health will send a copy of these products ' products to the General Directorate of Livestock.

The security data tab will be elaborated as follows:

(a) For biocidal products classified as hazardous, in accordance with Article 10 of Royal Decree 1078/1993.

(b) For active substances used exclusively in biocidal products, in accordance with the provisions of Article 23 of Royal Decree 363/1995.

Article 21. Advertising.

1. Any advertising of a biocidal product shall be accompanied by the phrases ' Use the biocidal products safely. Always read the label and product information before using it. " These phrases shall be clearly highlighted in the advertising package, and the word 'biocidal' may be replaced by the exact description of the type of product advertised, for example, wood protectors, disinfectants, biocidal products, surface, anti-fouling products, etc.

2. The advertising of biocidal products shall not present the product in such a way as to be misleading in terms of risks to humans or the environment, nor shall it include any mention as 'low-risk biocidal product', 'non-toxic', 'harmless', or any similar indication.

Article 22. Toxicological prevention and control of biocidal products.

The Ministry of Health and Consumer Affairs will establish a health information system and epidemiological surveillance aimed at preventing, detecting, diagnosing and treating health problems related to or caused by biocidal products.

The information collected by this information system will enable measures to be taken for the prevention and control of acute, subacute, chronic (carcinogenicity) toxicity, and reproductive toxicity.

The information system that will be coordinated by the Directorate-General for Public Health will collect information and provide it, where appropriate, to the following sources:

(a) Registers of the General Directorate of Public Health on biocidal products, new, existing, dangerous preparations and national and international scientific bases.

b) National Network for Monitoring, Inspection and Control of Chemicals and Rapid Exchange of Chemical Information System (SIRIPQ).

c) Hospital Network Emergency Services, Clinical Toxicology Units, and Primary Care Network.

d) Health statistics established by the National Health System and the National Statistics Institute.

(e) Health authorities responsible for the toxicological control of the Health Department of the Autonomous Communities.

f) Services of Toxicological Information of the National Institute of Toxicology (Madrid, Seville and Barcelona).

g) Scientific Societies, such as the Spanish Association of Toxicology. Clinical Toxicology section and other related entities.

The Directorate General of Public Health will keep informed, by the fastest possible means, the medical care units of the National Health System or those privately owned hospitals that do so. need, with respect to preventive and curative measures in case of urgency, with the collaboration of the National Institute of Toxicology through its Toxicological Information Service. The information provided, including the composition, shall be considered confidential.

Article 23. Administrative powers and competent authority:

1. Powers of the General Administration of the State.

(a) In accordance with Article 18 (6) and (11), Article 19, Article 23, Article 24, Article 25, Article 26, Article 27, Article 28 and Article 40 (1), (2), (5) and (6) of Law 14/1986 of 25 April, General of Health, and Royal Decree 840/2002 of 2 August, the Directorate General of Public Health of the Ministry of Health and Consumer Affairs will be the competent authority for all the provisions of this Royal Decree.

b) According to Royal Decree 1415/2000 of 21 July, Article 11, the Environmental Quality and Evaluation Directorate of the Ministry of the Environment, will be competent authority for environmental aspects.

(c) The General Directorate of Livestock of the Ministry of Agriculture, Fisheries and Food shall be competent authority for animal safety aspects.

d) For the exercise of these powers, and in order to ensure the correct application of the provisions of this Royal Decree, the Ministry of Health and Consumer Affairs, when necessary, will coordinate its actions with the other bodies of the Administrations

Public, facilitating, in accordance with the provisions of article 4.1.c) of Law 30/1992, of November 26, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, as amended by Law 4/1999, of 13 November, the information they require for the performance of their duties.

2. Powers of the Autonomous Communities:

Corresponding to the competent bodies of the Autonomous Communities the functions of surveillance, inspection and control of the correct compliance with the provisions of this Royal Decree, in their respective territories, as well as the exercise of sanctioning powers.

Article 24. Exchange of information with the Autonomous Communities.

1. The Ministry of Health and Consumer Affairs shall provide the Autonomous Communities with the guidance, information or other information available to them so that they can properly perform their duties. To this end, it will use the National Network for Surveillance, Inspection and Control, as well as the Rapid Exchange of Information on Chemicals, established by the Directorate General of Public Health of the Ministry of Health and Consumer Affairs. The Ministry of Health of the Autonomous Communities, in the coordination bodies of the Environmental Health Ponance and in the Public Health Commission of the National Health System. It will also be able to implement the measures that are most appropriate to achieve the effective coordination of actions aimed at the prevention of risks, epidemiological surveillance and compliance with the provisions of this Royal Decree.

2. Without prejudice to the coordination and cooperation measures to be established, the authorities of the Autonomous Communities shall report annually to the Ministry of Health and Consumer Affairs on the activities they undertake to ensure the implementation of this Regulation. disposition.

3. The Ministry of Health and Consumer Affairs shall keep the Ministry of Agriculture, Fisheries and Food informed of biocidal products for livestock use, in order to facilitate their coordination with the Autonomous Communities.

Article 25. Safeguard clause.

Where a biocidal product authorised or registered in accordance with this Royal Decree constitutes an unacceptable risk to human or animal health or to the environment, the Ministry of Health and Consumer Affairs and, where appropriate, when where appropriate, in coordination with the Ministry of the Environment and/or the Ministry of Agriculture, Fisheries and Food for the aspects of their respective competences, may temporarily restrict or prohibit the use or sale of that product. The Ministry of Health and Consumer Affairs shall immediately inform the Commission and the other Member States of the reasons for its decision. It shall inform the manufacturer or the person responsible for placing the biocidal product on the market of the measures taken.

In any case, it will be up to what is definitively decided by the competent community bodies.

Article 26. Official Register of Biocidal Products.

All biocidal products, evaluated in accordance with the procedures laid down in this Royal Decree, both for authorisation and for registration as low-risk biocidal products, shall be entered in the Official Register of Biocidal Products. Directorate-General for Public Health of the Ministry of Health and Consumer Affairs.

Article 27. Requirements for manufacturing, storage, marketing and application.

premises or facilities where biocidal products are manufactured and/or formulated, as well as those storing and/or placing on the market authorised biocidal products for professional use and biocidal product companies to be determined in accordance with the rules, must be registered in the Official Register of Biocidal Facilities and Services of each Autonomous Community. This register shall be managed by the competent health authority.

Article 28. Official Book of Biocidal Movements

Biocides classified in the toxic and very toxic categories shall be marketed and applied under a control system based on the registration of each operation, with the corresponding reference of the manufacturing lot and the number of the Official Register of Biocidal Facilities and Services, in an Official Biocidal Movements book, to be supervised by the competent authority of the Autonomous Community.

Article 29. Training courses.

Without prejudice to the provisions of Law 31/1995 of 8 November on the Prevention of Occupational Risks, the staff of the biocidal services companies must exceed the training courses or tests approved by the Ministry of Health Health and Consumer Affairs, which, if necessary, will coordinate its actions with other Ministries.

Article 30. Violations.

Without prejudice to other regulations that may be applicable, the violations committed against the provisions of this Royal Decree will have the consideration of administrative violations of the health regulations, in accordance with the provisions of Chapter VI of Title I of Law 14/1986 of 25 April 1986, General of Health and of the other provisions resulting from implementation.

The infractions are described as mild, severe and very serious, taking into account the health risk criteria, the amount of the possible benefit obtained, the degree of intentionality, the severity of the health and social changes produced, generalization of the violation and recidivism.

1. Are considered minor infractions: Failure to comply with the requirements, obligations or prohibitions established in this Royal Decree or in the provisions that develop it, as long as they are not considered to be serious or very serious. Article 35-A-3. of the General Health Law is required.

2. Serious violations are considered:

(a) The resistance to providing data to the competent authority in relation to the data required for the assessment process for the registration, authorisation and placing on the market of biocidal products, as required by Article 35-B-4. and 5. the General Health Law.

(b) The non-contribution of the data required in the safety data sheet of the biocidal product referred to in Article 20, as provided for in Article 35-B-1. and 2. of the General Health Law.

(c) Failure to comply with the reporting obligation and the requirements set out in Articles 14.1 and 16, where its rating is not deemed to be very serious, considered to be the case provided for in the Article 35-B-1. and 4. th of the General Health Law.

(d) Non-compliance with the requirements for classification, packaging and labelling laid down in Article 19, considered as being of course provided for in Article 35-B-1. and 2. of the General Health Law.

e) The placing on the market of biocidal products for which the authorisation or registration is expired, except for a provisional extension of the product, as provided for in Article 35-B-1. and 4. of the General Health Law.

(f) The carrying out of advertising of biocidal products which does not comply with the provisions of Article 21 of this Royal Decree and other implementing rules, which is considered to be the case provided for in Article 35-B-1. and 4. of the General Law Health.

g) The recidivism in the commission of minor infractions in the last three months, as provided for in article 35-B-7. of the General Law of Health.

3. Very serious violations are considered:

(a) The placing on the market of biocidal products without prior authorisation or registration, considered as being of course in those provided for in Article 35-C-1. and 2. of the General Health Law.

(b) The placing on the market of prohibited or limited biocidal products for a given use, as well as those which would have been ordered to withdraw from the market, considered as being the case provided for in Article 35-C-1. and 2. General of Health.

(c) The placing on the market of biocidal products with active substances not included in Annex I or IA and the placing on the market as basic substances of substances not included in Annex IB, considered as being of the nature of those provided for in the Annex. Article 35-C-1. and 2. of the General Health Law.

(d) the manufacture, storage, placing on the market or application of biocidal products, under conditions which pose a serious risk to public health or which do not comply with the provisions of the Register of Biocidal Facilities and Services; as required by Article 35-C-1. and 2. of the General Health Law.

e) The distortion of the information necessary for the authorisation or registration, its modifications and renewals, as well as the information to be included in the labelling and the safety data sheet, as required by the Article 35-C-1. and 2. th of the General Health Law.

(f) The use of biocidal products in applications, conditions or application techniques other than those authorised, as well as the non-compliance with the established safety deadlines as provided for in Article 35-C-1. and 2. General Health Law.

g) Changes in the unauthorised composition affecting the active substances or the possible risks, as well as the unauthorised changes of the other components of the biocidal product, considered as assumptions as provided for in the Article 35-C-1. and 2. th of the General Health Law.

(h) Failure to comply with the measures taken pursuant to the safeguard clause, as provided for in Article 35-C-1. and 2. of the General Health Law.

i) The recidivism in the commission of serious misconduct in the last five years, as required by article 35-C-8. of the General Law of Health.

Article 31. Penalties.

1. The actions or omissions constituting an infringement, as provided for in Article 30 of this Royal Decree, shall be the subject of the administrative penalties provided for in Article 36 of Law 14/1986 of 25 April, General Health.

2. Such penalties shall be imposed upon instruction of the relevant file, in accordance with the provisions of Law No 30/1992 of 26 November of the Legal Regime of Public Administrations and of the Common Administrative Procedure, as amended by Law 4/1999 of 13 January 1999 and in the rules for the development thereof.

3. These penalties shall be independent of those which may be imposed by other competent, state or regional authorities, on grounds other than those for the infringement of health legislation.

For such purposes, the various authorities shall exchange the background and information in their possession.

Single additional disposition. Records.

Pesticides for use in the food industry, for use in personal hygiene and for the disinfectants of clinical and surgical environments and for the use of livestock assigned to the records referred to in the Royal Decree 3349/1983, of 30 November, and Royal Decree 443/1994, of 11 March, will continue to be registered in their respective Registers of the Directorate General of Public Health, and Directorate General of Pharmacy and Health Products of the Ministry of Health and Consumer Affairs, and the General Directorate of Livestock of the Ministry of Agriculture, Fisheries and Food, during the transitional period established in the first transitional provision of this Royal Decree. For these products and during this transitional period, the Order of 24 February 1993, which normalizes the registration and operation of the Register of Pesticide Establishments and Services, will continue to apply.

Once a decision has been taken at Community level regarding the inclusion or non-inclusion of the active substance in Annex I, IA or IB, these biocidal products shall be attached to the Official Register of Biocidal Products of the European Union. General Public Health, who shall grant, amend or revoke, as appropriate, the authorisations or, where appropriate, the records of biocidal products containing those active substances and comply with the procedures laid down in this Royal Decree.

Pesticides used as protection for the preservation of sawwood, processed or processed in the Official Register of Products and Plant Health of the Ministry of Agriculture of the Ministry of Agriculture of Agriculture, Fisheries and Food, shall be transferred within six months, from the publication of this Royal Decree, to the Registry of the Directorate General of Public Health.

First transient disposition. Time limits for the review of active substances.

By way of derogation from Article 3 (1), Article 5 (1), Article 8 (3) and (5), and without prejudice to Article 17 (7), as well as the provisions of the third subparagraph of Article 5 (1), For a period of 10 years from 14 May 2000, provision may be made for

following:

applying Royal Decree 3349/1983 and subsequent amendments, for non-agricultural pesticide products (biocidal products) regulated therein and containing active substances marketed on the date indicated, until such time as taken a decision at Community level on the inclusion or not of the active substance in Annex I, IA or IB.

The remainder of biocidal products containing active substances on the market on 14 May 2000 and for which the said Royal Decree does not apply may continue to be placed on the market until the taken a decision at Community level on the inclusion or non-inclusion of those active substances in Annex I, IA, or IB. Once such a decision has been taken, biocidal products containing such active substances and complying with the provisions of this Royal Decree shall be entered in the Official Register of Biocidal Products of the Directorate-General for Public Health, who shall grant the authorisations or, where appropriate, the records of those biocidal products.

A review procedure for active substances placed on the market prior to 14 May 2000 as active substances for biocidal products for purposes other than those defined in Annex I shall be established during this 10-year period. paragraphs (o) and (p) of Article 2.

This review will be carried out in accordance with the Regulations that the European Union Commission will publish periodically, which will collect the necessary provisions for the establishment and implementation of the programme, including the setting priorities for the evaluation of the various active substances and the corresponding timetable. The first of these Regulations, Commission Regulation (EC) No 1896/2000 of 7 September 2000 has already been published.

Second transient disposition. Control of biocidal products with existing active substances.

In order to respond to a medical order requirement and in accordance with the provisions of Article 22 of this Royal Decree, the manufacturers or persons responsible for placing the products on the market concerned in the second subparagraph of the first transitional provision, they shall send to the Directorate-General for Public Health before 14 May 2003, preferably in electronic form, the information relating to the chemical composition, the label and the Case-book of all biocidal products placed on the market before the date of the entry into force of this Royal Decree.

In addition, they must send to the Directorate General of Public Health, at the same time that the product is placed on the market, the information mentioned above, for all the biocidal products that are marketed after the entry into force of the this Royal Decree.

Transitional provision third. Deadlines for updating old records.

All products entered in the corresponding records of the Directorate General of Pharmacy and Sanitary Products that have been transferred to the Directorate General of Public Health, on the basis of Royal Decree 162/1991 and not have been accommodated in accordance with the provisions laid down in the technical-sanitary regulation of pesticides, shall be within six months of the entry into force of this Royal Decree in order to request their adaptation and reclassification. Also, the environmental and use disinfectant products in the food industry, registered prior to the year 1991 in the Directorate General of Pharmacy and Health Products or in the General Health Registry, will have a Six months from the entry into force of this Royal Decree to apply for adaptation and reclassification.

Similarly, all disinfectant products for environmental use and use in the food industry that are being placed on the market and are not registered, will have a period of six months from the entry into force of the this Royal Decree to request your registration. The same period shall apply for the regularisation of wood protectors for which the provisions laid down in the second provision of Royal Decree 2163/1994 of 4 November 1994 laying down the system shall no longer apply. harmonised Community authorisation to place plant protection products on the market and use.

Single repeal provision. Regulatory repeal.

How many provisions of equal or lower rank are opposed to what is established in this Royal Decree

Final disposition first. Competence title.

This Royal Decree is dictated by the provisions of Article 149.1.16. and 23. of the Constitution and in accordance with the provisions of Article 40 (1), (2), (5) and (6) of Law 14/1986 of 25 April 1986, Health.

Final disposition second. Faculty of development.

The Ministers for Health and Consumer Affairs, Agriculture, Fisheries and Food and the Environment are empowered to proceed to the development of the provisions of this Royal Decree, as well as to dictate the rules necessary for the updating of the technical annexes contained therein and the coordination of the requirements for registration in the Registers of the Autonomous Communities, determining the conditions of manufacture, storage, marketing and application and the conditions and programmes of training courses for staff of the biocidal services companies.

Final disposition third. Budgetary adjustment.

The Ministry of Finance will carry out the precise budgetary changes for the implementation of the provisions of this Royal Decree.

Final disposition fourth. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given in Madrid to 11 October 2002.

JOHN CARLOS R.

The First Vice President of the Government and Minister of the Presidency,

MARIANO RAJOY BREY

ANNEX I

List of active substances for inclusion in biocidal products

ANNEX IA

List of active substances for inclusion in low-risk biocidal products

ANNEX IB

List of basic substances

ANNEX IIA

Common fundamental documentation for active substances

CHEMICALS

1. The documentation on active substances should at least respond to all the points mentioned in the list of "Documentation requirements". The answers must be backed up by data. The requirements of the documentation shall be up to the technical progress.

2. Information which is not necessary due to the nature of the biocidal product or uses to which it is intended shall not be provided. The same applies when it is not scientifically necessary or technically possible to provide the information. In such cases, an acceptable justification shall be provided for the competent authority. Such justification may be the existence of a framework formulation to which the applicant has the right to access.

Documentation requirements

I. Requester.

II. Identification of the active substance.

III. Physical and chemical properties of the active substance.

IV. Detection and identification methods.

V. Effectiveness vis-à-vis the bodies to which it is intended and intended uses.

VI. Toxicological profile for humans and animals, including metabolism.

VII. Ecotoxicological profile, including scope and behaviour in the environment.

VIII. Measures necessary for the protection of humans, animals and the environment.

IX. Classification and labelling.

X. Summary and evaluation of II-IX.

Previous points should be supported by the following data:

I. Requester:

1.1 Name, last name and address, etc.

1.2 Manufacturer of the active substance (name, last name, address and installation situation).

II. Identification:

2.1 Common name proposed or accepted by ISO and synonyms.

2.2 Chemical Denomination (IUPAC nomenclature).

2.3 Manufacturer's experimentation code number.

2.4 CAS and CE numbers (if known).

2.5 Empirical and developed formulas (including all the details of any isomeric composition) and molecular mass.

2.6 Method of manufacture (abbreviated synthesis route) of the active substance.

2.7 Specification of purity of the active substance in g/kg or g/l, as appropriate.

2.8 Type of impurities and additives (e.g. stabilizers), together with the developed formula and the possible concentration expressed in g/kg or g/l, as appropriate.

2.9 Origin of the natural active substance or precursor or precursors of the active substance, for example, a floral extract.

2.10 Exposure data in accordance with Annex VIIA to Royal Decree 363/1995 of 10 March, approving the Regulation on the Notification of New Substances and Classification, Packaging and Labelling of Dangerous Substances.

III. Physical and chemical properties:

3.1 Merge point, boiling point, relative density (1).

3.2 Vapor Pressure (in Pa) (1).

3.3 Appearance (physical state, color) (2).

3.4 absorption spectrum (UV/VIS, IR, NMR) and, where applicable, mass spectrum and molar extinction at relevant wavelengths (1).

3.5 Solubility in water, including the effect of pH (5 to 9) and temperature on solubility, where appropriate (1).

3.6 Coefficient of n-octanol/water partition, including the effect of pH (5 to 9) and temperature.

3.7 Thermal stability and identity of the relevant decomposition products.

3.8 Inflamability, including self-inflammability, and the identity of the combustion products.

3.9 Flash point.

3.10 Surface Tension.

3.11 Explosive properties.

3.12 Combative properties.

3.13 Reactivity with packaging materials.

IV. Analytical methods of detection and identification:

4.1 Analytical methods for the determination of the pure active substance and, where appropriate, for the determination of decomposition products, isomers and relevant impurities of the active substance and additives (e.g. stabilizers).

4.2 Analytical methods, including the rate of recovery and the limits of detection of the active substance and its residues and, where appropriate, in:

a) Soil.

b) Air.

(c) Water: The applicant shall confirm that the substance and any of its metabolites and degradation and reaction products fall within the definition of pesticide defined in the current legislation on human consumption waters and that they may be reliably estimated at the parametric value specified in that regulation for each individual pesticide.

d) Fluid and body tissues of the human being and animals.

V. Effectiveness in relation to the organisms to which it is intended for the intended uses:

5.1 Function, e.g., fungicide, rodenticide, insecticide, bactericide.

5.2 Body or organisms to be controlled and products, organisms or objects to be protected.

5.3. Effects on the organisms to which it is intended and the likely concentration of the product when used.

5.4. Mode of action (including deadline).

5.5. Intended scope.

5.6. User: Industrial, professional, general public (not professional).

5.7. Information on occurrence or possible occurrence of resistance and appropriate strategies to address it.

5.8. Estimated quantities to be marketed annually, expressed in Tn.

VI. Toxicological and metabolic studies:

6.1. Acute toxicity.-For tests 6.1.1 to 6.1.3, substances other than gases must be administered by at least two routes, one of which must be oral. The choice of the second route will depend on the nature of the substance and the possible route of human exposure. Gases and volatile liquids should be administered by inhalation.

6.1.1. Oral.

6.1.2. Dermal.

6.1.3. By inhalation.

6.1.4. Skin and eye irritation (3).

6.1.5. Dermal sensitisation.

6.2. Metabolic studies in mammals.-Basic toxicity, including a dermal absorption study.

In the following studies 6.3 (where applicable), 6.4, 6.5, 6.7 and 6.8 it will be mandatory to use the oral route, unless it can be justified that another route is more appropriate.

6.3. Short-term toxicity by repeated dose (twenty-eight days).-This study will not be required when a subchronic rodent toxicity study is available.

6.4. Subchronic toxicity.-A ninety-day study in two species, one of rodent and one of non-rodent species.

6.5. Chronic toxicity (4)-A species of rodent and other species of mammal.

6.6. Genotoxicity studies.

6.6.1. In vitro study of genetic mutation in bacteria.

6.6.2. In vitro cytogenetic study in mammalian cells.

6.6.3. In vitro and separate gene mutation assay in mammalian cells.

6.6.4. If the results of 6.6.1, 6.6.2 or 6.6.3 are positive, a mutagenicity in vivo study (bone marrow assay for chromosomal lesions or micronucleus test) will be required.

6.6.5. If the results of 6.6.4 are negative but in vitro tests are positive, a second in vivo study will be performed to determine whether mutagenicity or evidence of DNA injury can be demonstrated in tissues other than the bone marrow.

6.6.6. If the results of 6.6.4 are positive, it will be necessary to test for possible effects on germ cells.

6.7. Carcinogenicity study (4).-A species of rodent and other species of mammal. These studies can be combined with those of 6.5.

6.8. Toxicity to reproductive function (5).

6.8.1. Teratogenicity test: Rabbit and a kind of rodent.

6.8.2. Fertility study: At least two generations, one species, male and female.

6.9. Medical data in anonymous form.

6.9.1. Medical surveillance data of the personnel of the manufacturing facilities, if available.

6.9.2. Direct observation, for example, clinical cases or cases of intoxication, if available.

6.9.3. Health records, both industry and any other available source.

6.9.4. Epidemiological studies of the general population, if available.

6.9.5. Diagnosis of intoxication including specific signs of intoxication and clinical trials, if available.

6.9.6. Awareness-raising or allergenisation observations, if available.

6.9.7. Specific treatment in case of accident or intoxication. First aid measures, antidotes and medical treatment, if known.

6.9.8. Prognosis of intoxication.

6.10. Summary of toxicology in mammals and conclusions, including the level of unobserved adverse effect (NOAEL), the non-effect level (NOEL), the overall assessment of all toxicological data and any other information on the active substance. Where possible, any worker protection measure that is suggested shall be included in the summary form.

VII. Ecotoxicological studies on the active substance:

7.1. Acute toxicity in fish.

7.2. Acute toxicity in "magna".

7.3. Algae growth inhibition assay.

7.4. Inhibition of microbial activity.

7.5. Bioconcentration. Scope and behaviour in the environment.

7.6. Degradation.

7.6.1. Biotic.

7.6.1.1. Easy biodegradability.

7.6.1.2. Intrinsic biodegradability, where appropriate.

7.6.2. Abiotics.

7.6.2.1. Hydrolysis based on the pH and identification of the decomposition products.

7.6.2.2. Phototransformation in water, including the identity of the processing products (I).

7.7. Preliminary absorption/desorption test.-When the results of this test so indicate, the tests described in paragraph 1.2 of Part XII.1 of Annex IIIA or those described in point 2.2 of Part XII.2 of the Annex shall be required. IIIA.

7.8. Summary of the ecotoxicological effects and the range and behaviour of the environment.

VIII. Measures necessary for the protection of humans, animals and the environment:

8.1. Precautions and best practices for handling, use, storage, transport and fire.

8.2. In case of fire, nature of the reaction products, combustion gases, etc.

8.3. Emergency measures in the event of an accident.

8.4. Possibility of destruction or decontamination after release: (a) Air, (b) water, including drinking water, (c) soil.

8.5. Waste management procedures for the active substance by industrial or professional users.

8.5.1. Possibility of reuse or recycling.

8.5.2. Possibility of neutralization of effects.

8.5.3. Controlled discharge conditions, including the conditions for removal of the leachate.

8.5.4. Controlled incineration conditions.

8.6. Observations of undesirable or undesirable side effects, for example, in beneficial organisms or other organisms other than the organism to which it is intended.

IX. Classification and Labelling:

Proposals, including the supporting arguments for the proposals for the classification and labelling of the active substance under Royal Decree 363/1995 of 10 March, approving the Notification Regulation New Substances and Classification, Packaging and Labelling of Dangerous Substances.

Danger Symbols.

Hazard indications.

Risks-type phrases.

Security-related phrases.

X. Summary and evaluation of II-IX.

(1) This data should be submitted in respect of the declared specification purified active substance.

(2) This data should be submitted in respect of the declared active substance.

(3) The eye irritation test will not be necessary when the active substance has been shown to have corrosive properties.

(4) The long-term toxicity and carcinogenicity of an active substance may not be requested when it is conclusively demonstrated that such tests are not necessary.

(5) If, in exceptional circumstances, it is stated that this test is not necessary, that statement must be fully justified.

ANNEX IIB

Fundamental data common to biocides

CHEMICAL PRODUCTS

1. The biocidal product documentation should at least respond to all the points mentioned in the list of 'Documentation requirements'. The answers must be backed up by data. The requirements of the documentation shall be up to the technical progress.

2. Information which is not necessary due to the nature of the biocidal product or uses to which it is intended shall not be provided. The same shall apply where it is not scientifically necessary or technically possible to provide the information. In such cases, an acceptable justification shall be provided for the competent authority. Such justification may be the existence of a framework formulation to which the applicant has the right to access.

3. The information may be obtained from the existing data when an acceptable justification is presented to the competent authority. In particular, and where possible, in order to minimise animal testing, the provisions contained in Royal Decree 1078/1993 of 2 July 1993 on the Classification, Packaging and Packaging Regulations should be applied. and Labelling Dangerous Preparations.

Documentation requirements

I. Requester.

II. Identification and composition of the biocidal product.

III. Physical and chemical properties of the biocidal product.

IV. Methods of identification and analysis of the biocidal product.

V. Intended uses of the product and efficacy in these uses.

VI. Toxicological data of the biocidal product (additional to those of the active substance).

VII. Ecotoxicological data of the biocidal product (additional to those of the active substance).

VIII. Measures to be taken for the protection of humans, animals and the environment.

IX. Classification, packaging and labelling of the biocidal product.

X. Summary and evaluation of II-IX.

Previous points should be supported by the following data:

I. Requester:

1.1. Name, surname and address, etc.

1.2. Manufacturer of the biocidal product and the active substance [names and addresses, including the situation of the installation (s)].

II. Identification:

2.1. Proposed trade name or commercial name, as well as the manufacturer's number of experimentation code, where applicable.

2.2. Detailed statement on the quantitative and qualitative composition of the biocidal product, e.g. active substance or substances, impurities, adjuvants or inert components.

2.3. Physical state and nature of the preparation, for example, emulsifiable concentrate, wettable powder or solution.

III. Physical, chemical and technical properties:

3.1. Appearance (physical state, color).

3.2. Explosive properties.

3.3. Oxidising properties.

3.4. Flash point and other indications of flammability or spontaneous ignition.

3.5. Acidity or alkalinity and, if necessary, pH (1 per 100 in water).

3.6. Relative density.

3.7. Storage stability: Stability and retention period. Effects of light, temperature and humidity on the technical characteristics of the biocidal product; reactivity against the material of the container.

3.8. Technical characteristics of the biocidal product, e.g. wettability, persistent foam formation, fluidity, spillability and pulverency.

3.9. Physico-chemical compatibility with other products, including other biocidal products with which their use is to be authorised.

IV. Methods of identification and analysis:

4.1. Analytical methods for determining the concentration of the active substance (s) in the biocidal product.

4.2. In so far as they are not referred to in point 4.2 of Annex IIA, analytical methods, including the percentage of recovery and limits for the detection of the toxicological and ecotoxicologically relevant components of the biocidal product or waste when appropriate in:

a) Soil.

b) Air.

c) Water (including drinking water).

d) Fluids and body tissues, humans and animals.

e) Treated food or feed.

V. Intended uses and effectiveness of these:

5.1. Product type and intended scope.

5.2. Application method, including the description of the system used.

5.3. Dose of application and, if appropriate, final concentration of the biocidal product and the active substance in the system where the preparation is to be used, e.g. cooling water, surface water or water used for heating.

5.4. Number and pace of applications and, where appropriate, any particular information concerning geographical or climatic variations or waiting periods necessary to protect the human being and animals.

5.5. Function, e.g. fungicide, rodenticide, insecticide, bactericide.

5.6. Harmful organisms or organisms to be controlled and products, organisms or objects to be protected.

5.7. Effects on the organisms to which it is intended.

5.8. Mode of action, including the time limit, in so far as it is not included in point 5.4 of Annex IIA.

5.9. User: Industrial, professional or general public (not professional). Data on effectiveness.

5.10. Proposed labelling declarations for the product and data relating to the efficacy to support such declarations, including any standardised protocols which have been used, laboratory tests or, where appropriate, testing of field.

5.11. Any other limitation of the effectiveness that is known, including resistance.

VI. Toxicological studies:

6.1. Acute toxicity.-For tests 6.1.1 to 6.1.3, biocidal products other than gases must be administered at least by two routes, one of which must be oral. The choice of the second route will depend on the nature of the substance and the possible route of human exposure. Gases and volatile liquids should be administered by inhalation.

6.1.1. Oral.

6.1.2. Dermal.

6.1.3. By inhalation.

6.1.4. In the case of biocidal products intended for use with other biocidal products, the mixture of biocidal products shall be tested, if possible, to study acute dermal toxicity and skin and eye irritation, as appropriate.

6.2. Skin and eye irritation (1).

6.3. Skin sensitisation.

6.4. Information on skin absorption.

6.5. Toxicological data for which non-active substances of toxicological importance (substances of possible risk) are available.

6.6. Information on the exposure of the biocidal product to the human being in general and to the operator.-Where necessary, the test (s) described in Annex IIA for the non-active substances of the preparation with toxicological significance shall be required (n).

VII. Ecotoxicological studies:

7.1. Foreseeable routes of penetration into the environment according to the intended use.

7.2. Information on the ecotoxicology of the active substance in the product, where it cannot be extrapolated from the information on the active substance itself.

7.3. Ecotoxicological information that is available for non-active substances of ecotoxicological importance (substances of possible risk), for example the information contained in safety data sheets.

VIII. Measures to be taken for the protection of humans, animals and the environment:

8.1. Precautions and best practices for handling, use, storage, transport or fire.

8.2. Specific treatment in the event of an accident, e.g. first aid, antidotes, medical treatment, if possible; emergency measures to protect the environment; to the extent that this is not included in point 8.3 of the Annex IIA.

8.3. Procedures, if any, for cleaning the application equipment.

8.4. Identification of the relevant combustion products in the event of fire.

8.5. Procedures for the management of waste from the biocidal product and its packaging for industrial and professional users and for the general public (non-professional users), for example, the possibility of reuse or recycling, neutralisation, Controlled discharge and incineration.

8.6. Possibility of destruction or decontamination in case of release:

a) Air.

b) Water, including drinking water.

c) Soil.

8.7. Undesirable or undesirable side effects, e.g. in beneficial organisms or other organisms other than the target organism.

8.8. Any type of repellent substance or poison control measures included in the preparation shall be specified with a view to preventing action against organisms other than the organism to which it is intended.

IX. Classification, packaging and labelling:

Packaging and labeling proposals.

Security data token proposals, if applicable.

Supporting arguments for classification and labelling in accordance with the principles of Article 19 of this Royal Decree: Symbol (s) of danger; indications of danger; type phrases relating to risks; type phrases relating to safety; instructions for use; packaging (type, materials, size, etc.), compatibility of the preparation with the proposed packaging materials to be included.

X. Summary and evaluation of II-IX.

(1) The eye irritation test will not be necessary when the active substance has been shown to have corrosive properties.

ANNEX IIIA

Additional documentation for active substances

CHEMICALS

1. The documentation on active substances should respond to at least all the items mentioned in the list of "Documentation requirements". The answers must be backed up by data. The requirements of the documentation shall be up to the technical progress.

2. Information which is not necessary due to the nature of the biocidal product or uses to which it is intended shall not be provided. The same shall apply where it is not scientifically necessary or technically possible to provide the information. In such cases, an acceptable justification shall be provided for the competent authority. Such justification may be the existence of a framework formulation to which the applicant has the right to access.

III. Physical and chemical properties:

1. Solubility in organic solvents, including the effect of temperature on solubility (1).

2. Stability in organic solvents used in biocidal products and the identity of the corresponding decomposition products (2).

IV. Analytical methods of detection and identification:

1. Analytical methods, including recovery rates and limits for the determination of the active substance and its corresponding residues in food or feed and, where appropriate, other products.

VI. Toxicological and metabolic studies:

1. Neurotoxicity study.-If the active substance is an organophosphorus compound or if there are other indications that the active substance may have neurotoxic properties, neurotoxic studies will be required. The species used in the test shall be the adult hen, unless it is justified that another test species is more appropriate. In their case, delayed neurotoxicity tests will be required. If anticholinesterase activity is detected, consideration should be given to the possibility of a response test to reactive agents.

2. Toxic effects on livestock and domestic animals.

3. Studies related to the exposure of the human to the active substance.

4. Food and feed.-If the active substance is to be used in preparations used in places where food is prepared, consumed or stored for human consumption or where feed is prepared, consumed or stored, the above tests shall be required. in point 1 of paragraph XI.

5. If any other tests related to the exposure of the human being to the active substance in the proposed biocidal products are deemed necessary, the tests referred to in paragraph XI (2) shall be required.

6. If the active substance is to be used in products intended to act against plants, tests shall be necessary to evaluate the toxic effects of the metabolites of the treated plants, if any, when they are different from those found in the animals.

7. Study of the mechanisms of action.-Any study necessary to clarify the effects described in the toxicity studies.

VII. Ecotoxicological studies:

1. Acute toxicity test in another non-aquatic organism other than the organism to which it is intended.

2. If the results of the ecotoxicological studies and the intended uses of the active substance indicate a hazard to the environment, the tests described in paragraphs XII and XIII shall be required.

3. If the result of the tests in paragraph 7.6.1.2 of Annex IIA is negative and if the likely route of disposal of the active substance and its preparations is the treatment of the waste water, the tests described in the paragraph shall be carried out. 4.1 of paragraph XIII.

4. Any other biodegradability test that is relevant according to the results of paragraphs 7.6.1.1 and 7.6.1.2 of Annex IIA.

5. Photolysis in the air (estimation method), including identification of decomposition products (1).

6. If the results of the tests referred to in paragraph 7.6.1.2 of Annex IIA or in paragraph 4 above indicate the need to do so, or if the active substance presents a low or absent general abiotic degradation, it is necessary to carry out the tests described in points 1.1, 2.1 and, where applicable, point 3 of paragraph XII.

VIII. Measures to be taken for the protection of humans, animals and the environment:

1. Identification of the substances listed in List I or in List II of the Annex to Directive 80 /68/EEC on the protection of groundwater against pollution caused by certain dangerous substances transposed into By: Law 29/1985 of 2 August, of Water (Article 94); Regulation of the Public Hydraulic Domain (Articles 256 to 258) and Royal Decree 1315/1992 of 30 October 1992 amending the Regulation of the Hydraulic Public Domain, which develops the Preliminary Titles, I, IV, V, VI, and VII of the Law 29/1985, of 2 August, of Aguas, approved by Royal Decree 849/1986, of 11 April.

XI. Additional studies on human health:

1. Studies in food and feed:

1.1 Identification of decomposition and reaction products and metabolites of the active substance in treated or contaminated food or feed.

1.2 Behavior of the residues of the active substance, its decomposition products and, where appropriate, its metabolites in treated or contaminated food or feed, including elimination kinetics.

1.3 Global balance of active substance matter.

Data from the supervised trials on the waste, which sufficiently demonstrate that the residues presumably resulting from the proposed use will not be of concern to human or animal health.

1.4 Estimate of actual or potential exposure of humans to the active substance by diet or other means.

1.5 If the residues of the active substance are maintained in feed for a significant period of time, feed and metabolism studies in livestock will be required to allow for the assessment of the residues in the feed. food of animal origin.

1.6 Effects of industrial treatment or domestic preparation on the nature and extent of the residues of the active substance.

1.7 Proposed acceptable wastes and justification for their acceptability.

1.8 Any other available information that is deemed relevant.

1.9 Summary and evaluation of data provided in points 1.1 to 1.8.

2. Other tests relating to the exposure of the human being.-Appropriate tests shall be required, as well as a justified case.

XII. Additional studies on the range and behaviour of the environment:

1. Soil scope and behavior:

1.1 Speed and decomposition pathways, including the identification of the processes involved and the identification of any metabolites or decomposition products in at least three types of soil under conditions appropriate.

1.2 Absorption and desorption in at least three soil types and, where appropriate, absorption and desorption of metabolites and decomposition products.

1.3 Mobility in at least three types of soil and, where appropriate, the mobility of metabolites and decomposition products.

1.4 Magnitude and nature of fixed waste.

2. Water range and behaviour:

2.1 Speed and decomposition pathways in aquatic systems (as soon as it is not covered by paragraph 7.6 of Annex IIA), including identification of metabolites and decomposition products.

2.2 Absorption and desorption in water (sedimentary systems) and, where appropriate, absorption and desorption of metabolites and decomposition products.

3. Air range and behaviour.-If the active substance is to be used in fumigation preparations, it is to be applied by spraying, it is volatile or if any other information indicates that it is relevant, the speed and the (b) the breakdown of the air into the air to the extent that it is not referred to in paragraph VII (5

.

4. Summary and evaluation of Parts 1, 2 and 3.

XIII. Additional ecotoxicological studies:

1. Effects on birds:

1.1 Acute oral toxicity: It will not be necessary if a species of birds has been selected in the study under point 1 of paragraph VII.

1.2 Short-term Toxicity: Eight-day study of duration in the diet of at least one species (other than chicken).

1.3 Effects on playback.

2. Effects on aquatic organisms:

2.1 prolonged toxicity in a suitable species of fish.

2.2 Effects on the reproduction and growth rate of a suitable species of fish.

2.3 Bioaccumulation in a suitable species of fish.

2.4 Reproduction and growth rate of the "magna".

3. Effects on other organisms other than the organism to which it is intended:

3.1 Acute toxicity for bees and other beneficial arthropods, for example, predators. A test body other than that used in paragraph VII (1) shall be chosen.

3.2 Toxicity for earthworms and other soil macroorganisms other than the organism to which it is intended.

3.3 Effects on soil microorganisms other than the organism to which it is intended.

3.4 Effects on any other specific organism, other than the organism to which it is intended (flora and fauna), considered to be at risk.

4. Other effects:

4.1 Inhibition of breathing in activated sludge.

5. Summary and evaluation of 1, 2, 3 and 4.

(1) This data shall be provided for the purified active substance whose specification is indicated.

(2) This data shall be provided for the active substance whose specification is indicated.

ANNEX IIIB

Additional documentation for biocidal products

CHEMICAL PRODUCTS

1. The biocidal product documentation should respond to at least all the items mentioned in the list of "Documentation requirements". The answers must be backed up by data. The requirements of the documentation shall be up to the technical progress.

2. No information shall be provided which is not necessary due to the nature of the biocidal product or its proposed uses. The same shall apply where it is not scientifically necessary or technically possible to provide the information. In such cases, an acceptable communication shall be submitted to the competent authority.

Such justification may be the existence of a framework formulation to which the applicant has the right to access.

3. The information may be obtained from the existing data when an acceptable justification is presented to the competent authority. In particular, and wherever possible, in order to minimise animal testing, the provisions contained in Royal Decree 1078/1993 of 2 July 1993 on the classification, packaging and labelling of animals should be applied. labelling of dangerous preparations.

XI. Additional studies related to human health:

1. Studies in food and feed:

1.1 If the residues of the biocidal product are kept in feed for a significant period of time, feed and metabolism studies shall be required in livestock to allow the assessment of residues in food of origin. animal.

1.2 Effects of industrial processing or domestic preparation on the nature and extent of the product's waste.

2. Other tests relating to the exposure of the human being.-Appropriate tests shall be required, as well as a reasoned case for the biocidal product.

XII. Additional studies on the range and behaviour of the environment:

1. Where relevant, all the information required in paragraph XII of Annex IIIA.

2. Distribution and dissipation tests at:

a) Soil.

b) Water.

c) Air.

The test requirements of paragraphs 1 and 2 above are applicable only to the relevant ecotoxicological elements of the biocidal product.

XIII. Additional ecotoxicological studies:

1. Effects on birds:

1.1 Acute oral toxicity, if not already performed in accordance with the provisions of point 7 of Annex IIB.

2. Effects on aquatic organisms:

2.1 In case of application on, inside or near surface water.

2.1.1 Particular studies with fish and other aquatic organisms.

2.1.2 Data on residues in fish relating to the active substance, including metabolites with toxicological significance.

2.1.3 The studies referred to in points 2.1, 2.2, 2.3 and 2.4 of paragraph XIII of Annex IIIA may be required for the relevant components of the biocidal product.

2.2 If the biocidal product is to be sprayed near surface water, a study of the spray mist may be required in order to assess the risks to aquatic organisms under field conditions.

3. Effects on other organisms other than the organisms to which it is intended:

3.1 Toxicity for terrestrial vertebrates other than birds.

3.2 Acute toxicity to bees.

3.3 Effects on beneficial arthropods other than bees.

3.4 Effects on earthworms and other soil macroorganisms other than the organisms to which they are intended to be considered at risk.

3.5 Effects on soil microorganisms other than the organism to which it is intended.

3.6 Effects on any other specific organisms other than the organism to which it is intended (flora and fauna), which are considered to be at risk.

3.7 If the biocidal product is in the form of bait or granules.

3.7.1 Monitored trials for risk assessment for organisms other than the organisms to which it is intended for field conditions.

3.7.2 Studies of acceptance of the biocidal product by ingestion in any organisms other than the organisms to which it is intended to be considered at risk.

4. Summary and evaluation of 1, 2 and 3.

ANNEX IVA

Documentation for active substances

FUNGI, MICROORGANISMS AND VIRUSES

1. The documentation on the active bodies shall be at least to all the points mentioned in the list of "Documentation requirements".

Responses must be backed by data. The requirements of the documentation shall be up to the technical progress.

2. No information shall be provided which is not necessary due to the nature of the biocidal product or its proposed uses. The same shall apply where it is not scientifically necessary or technically possible to provide the information. In such cases, an acceptable communication shall be submitted to the competent authority.

Such justification may be the existence of a framework formulation to which the applicant has the right to access.

Documentation requirements

I. Data from the requester.

II. Identification of the active organism.

III. Source of the active body.

IV. Detection and identification methods.

V. Biological properties of the active organism, including pathogenicity and infectivity for the target organisms and for those who are not, including the human being.

VI. Effectiveness and intended uses.

VII. Toxicological profile for humans and animals, including the metabolism of toxins.

VIII. Ecotoxicological profile, including the extent and behaviour in the environment of the organisms and the toxins they produce.

IX. Measures necessary for the protection of the human being, the organisms other than the organism to which it is intended and the environment.

X. Classification and labelling.

XI. Summary and evaluation of II-X.

Previous points should be supported by the following data:

I. Requester:

1.1 Requester (name, last name, address, etc.).

1.2 Manufacturer (first name, last name, address, installation situation).

II. Identification of the body:

2.1 Common name of the body (including alternative and substituted names).

2.2 Taxonomic name and strain, indicating whether it is a strain variant or a mutant strain; in the case of virus, taxonomic name of the agent, serotype, strain or mutant.

2.3 Reference number for the crop and collection where the crop is deposited.

2.4 Methods, procedures and criteria used to determine the presence and identity of organism (e.g. morphology, biochemistry, serology, etc.).

III. Source of body:

3.1 Presence in nature or otherwise.

3.2 Methods of isolation of the body or the active strain.

3.3 Crop methods.

3.4 Method of production with details of the confinement and procedure used to maintain the quality and ensure a uniform source of the active organism. In the case of mutant strains, detailed production and isolation data shall be provided, as well as any known differences between the mutant strains and the wild and parental strains.

3.5 Composition of the final material of the active organism, i.e. nature, purity, identity, properties and content of any foreign impurity or organism.

3.6 Methods to prevent contamination and the virulence loss of the pattern crop.

3.7 Waste Management Procedures.

IV. Detection and identification methods:

4.1 Methods of determining the presence and identity of the organism.

4.2 Methods of determining the identity and purity of the pattern culture from which the batches are produced and the results obtained, including information on the variability.

4.3 Methods used to demonstrate the microbiological purity of the final product and control of contaminants at an acceptable level, obtained results and information on variability.

4.4 Methods used to demonstrate that the active agent is free from contamination by human and mammalian pathogens, including, in the case of protozoa and fungi, the effects of temperature (at 35 oC and at other temperatures relevant).

4.5 Methods for determining viable or non-viable residues (e.g. toxins) in treated products, food, feed, human or animal body tissues and tissues, soil, water and air, where appropriate.

V. Biological properties of the organism:

5.1 History of the body and its use, including as far as its general natural history is known and, if appropriate, its geographical distribution.

5.2 Relations with vertebrate pathogens, invertebrates, plants or other organisms.

5.3 Effects on the organism to which it is intended.

Pathogenicity or type of antagonism towards the host. Details of the specificity range for the host will be given.

5.4 Transmissibility, infective dose and mode of action, including information on the presence, absence or production of toxins, together with information on the nature, identity, chemical structure, stability and activity of These, where applicable.

5.5 Possible effects on organisms other than the organism to which it is closely related, including infectivity, pathogenicity and transmissibility.

5.6 Transmissibility to organisms other than the organism to which it is intended.

5.7 Any other biological effect on organisms other than the organism to which it is intended, when used appropriately.

5.8 Infectivity and physical stability when used appropriately.

5.9 Genetic stability in the environmental conditions of the proposed use.

5.10 Any type of pathogenicity and infectivity for humans and animals under immunosuppression conditions.

5.11 Pathogenicity and infectivity for known parasites or predators of the species to which it is intended.

VI. Effectiveness and intended uses:

6.1 Controlled harmful organisms and materials, substances, organisms or products to be treated or protected.

6.2 predicted Usos, e.g., insecticide, disinfectant, anti-fouling biocide, etc.

6.3 Information or observations on undesirable or undesirable side effects.

6.4 Information about occurrence or possible occurrence of resistance development and possible strategies to address it.

6.5 Effects on the organisms to which it is intended.

6.6 User category.

VII. Toxicological and metabolic studies:

7.1 Acute Toxicity.-In cases where a single dose is not appropriate, a series of evaluation tests will be performed to detect agents of high toxicity and their infectivity.

1) Oral;

2) dermal;

3) by inhalation;

4) skin irritation and, if necessary, ocular;

5) skin sensitisation and, if necessary, respiratory; and,

6) in case of viruses and viroids, studies in cell cultures using purified infectious viruses and primary cell cultures of mammalian, bird and fish cells.

7.2 Subchronic Toxicity.-Ninety-day study, two species, one rodent and one non-rodent species.

1) Oral administration;

2) other routes (inhalation, dermal) where appropriate; and,

3) in the case of viruses and viroids, infectivity tests performed by bioassay or in an appropriate cell culture at least seven days after administration to test animals.

7.3 Chronic Toxicity.-Two species, one rodent and one other mammal, by oral administration unless there is another appropriate route.

7.4 carcinogenicity study.-It can be combined with the studies in point 7.3. A rodent and other mammal.

7.5 genotoxicity studies.-As specified in point 6.6 of section VI of Annex IIA.

7.6 Toxicity for playback:

Teratogenicity test: Rabbit and a kind of rodent.

Fertility study: A species, minimum two generations, male and female.

7.7 metabolism studies.-Basic toxicity, absorption (including dermal absorption), distribution and excretion in mammals, including elucidation of metabolic pathways.

7.8 Neurotoxicity studies required when there is any indication of anticholinesterase activity or other neurotoxic effects. Where appropriate, delayed neurotoxicity tests shall be performed using adult hens.

7.9 Immunotoxicity studies, for example, allergenicity.

7.10 Accidental exposure studies: Requiring when the active substance is in products to be used in sites where food or feed is prepared, consumed or stored and where livestock or domestic animals may be exposed to treated areas or materials.

7.11 Human exposure data, including:

1) Medical data in anonymous form (if available);

2) health records and medical surveillance data of the staff of the manufacturing facility (if available);

3) epidemiological data (if available);

4) intoxication accident data;

5) poisoning diagnoses (signs and symptoms), including details of analytical tests;

6) proposed treatment for intoxication and prognosis.

7.12 Toxicology summary in mammals: Conclusions (including NOAEL, NOEL and, if appropriate, IDA), overall assessment of all toxicological, pathogenic and infectivity data and any other information concerning the active body. A summary of suggestions for user protection measures, where possible, will be included.

VIII. Ecotoxicological studies:

8.1 Acute Toxicity in Fish.

8.2 Acute Toxicity in "Magna Nia".

8.3 Effects on the growth of algae (inhibition assay).

8.4 Acute toxicity in another non-aquatic organism other than the organism to which it is intended.

8.5 Pathogenicity and infectivity in bees and earthworms.

8.6 Acute toxicity or pathogenicity and infectivity in other organisms other than the organism to which it is intended to be considered at risk.

8.7 Effects, if any, on other species of fauna and flora.

8.8 When toxins are produced, the data referred to in points 7.1 to 7.5 of Annex IIA shall be provided.

Scope and behavior in the environment.

8.9 Dispersion, mobility, multiplication and persistence in air, soil and water.

8.10 When toxins are produced, the data referred to in points 7.6 to 7.8 of Annex IIA shall be provided.

IX. Measures necessary for the protection of the human being, the organisms other than the organism to which it is intended and the environment:

9.1 Methods and precautions to be taken for storage, handling, transportation and use, or in case of fire or other probable accident.

9.2 Any circumstances or circumstances of the environment in which the active body should not be used.

9.3 Possibility of transforming the organism into non-infectious and any method to do so.

9.4 Consequences of air pollution, soil and water, in particular drinking water.

9.5 Emergency measures in the event of an accident.

9.6 Waste management procedures of the active organism, including the characteristics of the leachate in the disposal zone.

9.7 Possibility of destruction or decontamination after release in air, water, soil, or other, where applicable.

X. Classification and Labelling:

Proposals for classification in one of the risk groups proposed in Article 3 of Royal Decree 664/1997 of 12 May on the protection of workers from the risks related to exposure to agents On the basis of the proposal, together with indications of the need for the products to bear the sign of biological hazard appearing in Annex III to the Royal Decree, on the protection of the workers against risks related to exposure to biological agents during work.

XI. Summary and evaluation of II-X.

ANNEX IVB

Documentation for Biocides

FUNGI, MICROORGANISMS AND VIRUSES

1. The biocidal product documentation shall contain at least all the points mentioned in the following list, "Documentation requirements". The answers should be supported by data. The requirements of the documentation shall be up to the technical progress.

2. No information shall be provided which is not necessary due to the nature of the biocidal product or its proposed uses. The same shall apply where it is not scientifically necessary or technically possible to provide the information. In such cases, an acceptable communication shall be submitted to the competent authority.

Such justification may be the existence of a framework formulation to which the applicant has the right to access.

3. The information may be obtained from the existing data when an acceptable justification is presented to the competent authority. In particular, and where possible, in order to minimise animal testing, the provisions contained in Royal Decree 1078/1993 of 2 July 1993 on the classification, packaging and packaging of animals should be applied. and labelling of dangerous preparations.

Documentation requirements

I. Requester.

II. Identification and composition of the biocidal product.

III. Technical properties of the biocidal product and any complementary biocidal properties of the active organism.

IV. Methods of identification and analysis of the biocidal product.

V. Intended uses of the product and efficacy in these uses.

VI. Toxicological data of the biocidal product (additional to those of the active organism).

VII. Ecotoxicological data of the biocidal product (additional to those of the active organism).

VIII. Measures to be taken for the protection of humans, animals and the environment.

IX. Classification, packaging and labelling of the biocidal product.

X. Summary of II-IX.

Previous points should be supported by the following data:

I. Requester:

1.1 Name, last name, address, etc.

1.2 Manufacturer of the biocidal product and the active organism, including installation situation.

II. Identification of the biocidal product:

2.1 Trade name or proposed trade name, as well as the number of the product manufacturer's experimentation code, where applicable.

2.2 Detailed statement on the quantitative and qualitative composition of the biocidal product, for example, active organisms, inert components, foreign organisms, etc.

2.3 Physical status and nature of the biocidal product, e.g. emulsifiable concentrate, wettable powder, etc.

2.4 Concentration of the active organism in the material used.

III. Technical and biological properties:

3.1 Appearance (color and odor).

3.2 Storage: stability and validity time. Temperature effects, method of packaging and storage, etc., on the maintenance of biological activity.

3.3 Methods of determining storage stability and validity time.

3.4 Technical characteristics of the biocidal product:

3.4.1 Mojability.

3.4.2 Persistent foam training.

3.4.3 Suspense and stability of the suspension.

3.4.4 Wet sieve test and dry sieve test.

3.4.5 Granulometry, powder/fine content, hardness and friability.

3.4.6 In case of granules, sieve test and indication of the weight distribution of the granules, at least in fractions with particle sizes greater than 1 millimeter.

3.4.7 Active substance content in bait, granules or treated material particles.

3.4.8 Emulsionability, reemulsisionability and stability of the emulsion.

3.4.9 Fluidity, discharge capacity and pulverency.

3.5 Physical-chemical compatibility with other products, including other biocidal products with which their use is to be authorised.

3.6 Move power, adherence, and distribution after application.

3.7 All changes in the body's biological properties as a result of the formulation and, in particular, changes in pathogenicity or infectivity.

IV. Method of identification and analysis:

4.1 Analytical methods for determining the composition of the biocidal product.

4.2 Waste determination methods (e.g., bioassay).

4.3 Methods used to demonstrate the microbiological purity of the biocidal product.

4.4 Methods used to demonstrate that the biocidal product is free of any pathogen to humans or mammals or, if necessary, harmful pathogens for organisms other than the target organisms and the environment.

4.5 Techniques used to ensure uniform product and test methods for standardisation.

V. Intended uses and efficacy in these uses:

5.1 Use.-Product type (e.g., wood protector, insecticide, etc.) 5.2 Details of the intended use, e.g. types of controlled harmful organism, materials to be treated, etc.

5.3 Application Rate.

5.4 Where necessary, in light of the test results, any specific circumstances or environmental conditions in which the product may or may not be used.

5.5 Application Method.

5.6 Number and pace of applications.

5.7 Proposed Instructions for Use. Data on effectiveness.

5.8 Preliminary trials aimed at determining concentration.

5.9 Field Experimentation.

5.10 Information on possible development of resistance.

5.11 Effects on the Quality of Materials or Products Treated.

VI. Information on the complementary toxicity to that required for the active organism:

6.1 Single oral dose.

6.2 Single percutaneous dose.

6.3 Inhalation.

6.4 Skin irritation and, where appropriate, eye irritation.

6.5 Skin sensitisation.

6.6 Available toxicological data for non-active substances.

6.7 Exposition of the applicator.

6.7.1 Percutaneous or inhalation absorption, according to the formulation and method of application.

6.7.2 Likely exposure of the applicator under field conditions, including, where appropriate, the quantitative analysis of such exposure.

VII. Information on the complementary ecotoxicity to that required for the active organism:

7.1 Comments on undesirable or undesirable side effects, for example, in beneficial organisms or other organisms other than organisms to which it is intended or persisted in the environment.

VIII. Measures to be taken for the protection of the human being, the organisms other than the organism to which it is intended and the environment:

8.1 Recommended methods and precautions for handling, storage, transportation, and utilization.

8.2 Security Plashes, Necessary Suppression Period, or other precautions for human or animal protection.

8.3 Emergency measures in the event of an accident.

8.4 Procedures for the destruction or decontamination of the biocidal product and its packaging.

IX. Classification, packaging and labelling:

9.1 Proposals, including supporting arguments, classification, packaging and labelling.

1. Regarding non-biological components of the product in accordance with Royal Decree 1078/1993 of 2 July, approving the Regulation on the classification, packaging and labelling of dangerous preparations:

a) Symbol of danger.

b) Danger indications.

c) Type-relative phrases.

d) Security-related phrases.

2. Regarding the labelling of the active bodies with the appropriate risk group, as set out in Article 3 of Royal Decree 664/1997 of 12 May 1997 on the protection of workers against risks related to exposure to biological agents during work, together with the sign of biological hazard listed in the Royal Decree, if applicable.

9.2 Envase (type, materials, size, etc.), compatibility of the preparation with the proposed packaging materials.

9.3 Samples of the proposed package.

X. Summary of II-IX.

ANNEX V

Types and description of the biocidal products referred to in point (a) of Article 2 of this Royal Decree

These types of products are excluded from those regulated by their specific regulations mentioned in Article 1 (2) of this Royal Decree.

Core group 1: Disinfectants and general biocides:

These product types exclude cleaning products that do not have a biocidal effect, including liquid and powder detergents and similar products.

Product Type 1.-Biocides for Human Hygiene: Products in this group are the biocidal products used for human hygiene purposes.

Type of product 2.-Disinfectants used in the fields of private life and public health and other biocidal products: Products used for the disinfection of air, surfaces, materials, equipment and furniture not used in direct contact with food or feed in areas of the private, public and industrial sphere, including hospitals, as well as products used as alguicides.

The areas of use include, among others, swimming pools, aquariums, bathing waters and others; air conditioning systems; walls and floors of health centers and other institutions; chemical toilets, wastewater, wastes from hospitals, land, or other substrates (in the playground).

Product type 3.-Biocides for veterinary hygiene: Products in this group are biocidal products used for veterinary hygiene purposes, including products used in the areas in which they are housed, maintained or transport animals.

Product type 4.-Disinfectants for surfaces that are in contact with food and feed:

Products used in the disinfection of equipment, containers, utensils for consumption, surfaces or pipes related to the production, transport, storage or consumption of food, feed or beverages (including water (drinkable) for human beings or animals.

Product type 5.-Disinfectants for drinking water: Products used for the disinfection of drinking water (both for human beings and for animals).

Core Group 2: Conservants:

Product type 6.-Conservants for packaged products: Products for the preservation of processed products other than food or feed, in containers, by means of the control of microbial deterioration for the purpose of extend their useful life.

Product Type 7.-Conservants for movies:

Products used for the preservation of films or coatings by controlling microbial deterioration in order to protect the initial surface properties of materials or objects such as paints, plastics, sealants, wall adhesives, covers, papers, works of art.

Product Type 8.-Timber Protectors:

Products used for the protection of wood, from the sawmill stage including, or products derived from wood, by the control of organisms that destroy or alter wood.

Both preventive and curative products are included in this type of products.

Product type 9.-Protection of fibres, leather, rubber and polymerized materials: Products used for the preservation of fibrous or polymerized materials, such as leather, rubber, paper or textile products and rubber by the control of microbial deterioration.

Product Type 10.-Masonry Protectors:

Products used for the repair and repair of masonry materials or other building materials other than wood by controlling microbial deterioration and algal affectation.

Product type 11.-Protectors for liquids used in refrigeration systems and in industrial processes: Products used for the conservation of water or other liquids used in refrigeration and cooling systems industrial processing by the control of harmful organisms such as microbes, algae and molluscs.

Not included in this type of products are employees for the conservation of drinking water.

Product type 12.-Anti-mold products:

Products used for the prevention or control of the proliferation of moulds on materials, equipment and structures used in industrial processes, for example on wood and paper pulp, porous sand strata in the extraction of oil.

Product Type 13.-Metalisteria Liquid Protectors: Products used for the preservation of metalworking liquids by controlling microbial deterioration.

Core Group 3: Pesticides:

Product type 14.-Rodenticides: Products used for the control of mice, rats, or other rodents.

Product Type 15.-Avicides: Products used for bird control.

Product type 16.-Moluschides: Products used for the control of the molluscs.

Product Type 17.-Piscicides: Products used for the control of fish; employees are excluded from these products to treat fish diseases.

Product type 18.-Insecticides, acaricides and products to control other arthropods: Products used for the control of arthropods (insects, arachnids, crustaceans, etc.).

Product type 19.-Repelants and attractants: Products used for the control of harmful organisms (invertebrates such as fleas; vertebrates such as birds) by repulsion or attraction, including employees, direct or indirectly, for veterinary or human hygiene.

Core Group 4: Other Biocides:

Product type 20.-preservatives for food or feed: Products used for the preservation of food or feed through the control of harmful organisms.

Product Type 21.-Anti-fouling Products:

Products used for the control of the fixation and growth of scale organisms (microbes or higher forms of animal or plant species) on ships, aquaculture equipment or other aquatic structures.

Product type 22.-Liquid for embalming and taxidermy: Products used for the disinfection and preservation of animal or human corpses or part thereof.

Product type 23.-Control of other vertebrates: Products used for control of parasites.

ANNEX VI

Common principles for the risk assessment of biocidal products

CONTENT

Definitions:

Introduction.

Evaluation.

General principles.

Effects on the human being.

Effects on animals.

Effects on the environment.

Unacceptable effects.

Efficacy.

Summary.

Decision adoption:

General principles.

Effects on the human being.

Effects on animals.

Effects on the environment.

Unacceptable effects.

Efficacy.

Summary.

Overall integration of the findings.

Definitions

a) Identification of hazards: Identification of undesirable effects that a biocidal product is inherently capable of causing.

b) Evaluation of the dose (concentration) response (effect): Estimate of the ratio of the dose, or level of exposure, of an active substance or substance of possible risk to the biocidal product and the incidence and the severity of the effect.

(c) Exposure assessment: Calculation of the concentrations or doses to which human, animal or environmental compartments are or may be exposed, as a result of the determination of the emissions, transfer pathways and the movement rates of an active substance or potential risk contained in a biocidal product and its transformation or degradation.

(d) Risk characterization: Estimate of the incidence and severity of likely adverse effects on a human population, animals or environment compartments, due to actual or expected exposure to any active substance or potential risk contained in a biocidal product; may include the 'risk estimation', i.e. the quantification of that probability.

e) Environment: Water, including sediment, air, land, wildlife species, wild flora and all interrelationships between them, as well as the relationships between them and any living organism.

Introduction

1. This Annex lays down the principles to ensure that assessments made and decisions taken by a Member State concerning the authorisation of a biocidal product which is a chemical preparation give rise to a harmonised high level of protection for humans, animals or the environment, in accordance with Article 5 (1) (b) of this Royal Decree.

2. In order to ensure a harmonised high level of protection of human and animal health and the environment, any risk arising from the use of the biocidal product should be defined. To this end, a risk assessment shall be carried out in order to determine the acceptability or not of any risk identified in the expected normal use of the biocidal product. This shall be done by assessing the risks associated with each of the relevant components of the biocidal product.

3. An assessment of the risk of the active substance (s) present in the biocidal product shall always be carried out. This has already been done for the purposes of Annexes I, IA or IB. This risk assessment should include the identification of the hazards and, as appropriate, the assessment of the dose (concentration)-response (effect), exposure assessment and risk characterisation. Where a quantitative risk assessment cannot be carried out, a qualitative assessment shall be carried out.

4. Risk assessments shall also be carried out, as described above, of any other substance of potential risk present in the biocidal product, where relevant according to the use of the biocidal product.

5. In order to carry out the risk assessment, a series of data set out in Annex II, III and IV should be available. These data are flexible according to the type of product and the associated risks, taking into account the wide variety of product types. The minimum data required shall be the minimum data required to carry out an appropriate risk assessment. Member States shall take due account of the requirements of Articles 12 and 13 of this Royal Decree in order to avoid duplication in the submission of data.

However, the minimum set of data required for an active substance of any type of biocidal product shall be those set out in Annex VIIA to Royal Decree 363/1995 of 10 March 1995 approving the Regulation on notification of new substances and classification, packaging and labelling of dangerous substances; this data shall have been submitted and evaluated as part of the risk assessment necessary for the active substance to be listed in Annexes I, IA or IB of this Royal Decree. Data on substances of potential risk present in a biocidal product may also be required.

6. The results of the risk assessments carried out on an active substance and on a substance of possible risk present in the biocidal product shall be integrated in order to develop a comprehensive assessment of the biocidal product as such.

7. When making assessments and taking decisions on the authorisation of a biocidal product, the Member State shall:

(a) Take into account other relevant scientific or technical information available in respect of the properties of the biocidal product, its components, metabolites or residues.

b) Evaluate, where appropriate, the justifications submitted by the applicant for the failure to submit certain data.

8. The competent authority shall comply with the mutual recognition requirements set out in Article 4 (1), (2) and (5) of this Royal Decree.

9. It is known that many biocides present very slight differences in their composition, and this should be taken into account when examining the dossiers.

The concept of "frame formulation" is relevant at this point.

10. It is known that certain biocidal products are considered to pose a low risk only; these biocidal products, while observing the requirements of this Annex, are subject to a simplified procedure, as specified in Article 3 of this Royal Decree.

11. The application of these common principles shall enable the competent authority to decide on the authorisation of a biocidal product, which may be subject to restrictions on use or other conditions. In certain cases, the competent authority may request additional data before taking the decision on the authorisation.

12. During the process of evaluation and adoption of the decision, Member States and applicants shall collaborate in order to quickly resolve any questions requested around the required data, to determine promptly the need to carry out additional studies, modify any of the proposed conditions for the use of the biocidal product, or modify its nature or composition to ensure full compliance with the requirements of this Annex or of this Royal Decree. The administrative burden, in particular for small and medium-sized enterprises (SMEs), must be kept to the minimum necessary without prejudice to the level of protection required for humans, animals and the environment.

13. The views of the competent authority during the assessment and decision process shall be based on scientific principles, preferably recognised in the international sphere, and shall be provided with expert advice.

Evaluation

General principles:

14. The competent authority shall check whether the data submitted to them for the approval of the application for authorisation of a biocidal product are complete and of overall scientific quality. Upon acceptance of this data, the competent authority shall use them to carry out a risk assessment based on the proposed use of the biocidal product.

15. An assessment of the risk of the active substance present in the biocidal product should always be carried out. If there are also substances of possible risk in the biocidal product, a risk assessment shall be carried out for each of them. Such assessment shall cover the expected normal use of the biocidal product, in addition to the most unfavourable realistic case, including any relevant production and disposal aspects of both the biocidal product itself and any material treated with it.

16. For each active substance and each substance of possible risk present in the biocidal product, the risk assessment shall include an identification of the hazards and, if possible, the establishment of appropriate levels without observed adverse effect. (NOAEL). It shall also include, where appropriate, an assessment of the dose (concentration) response (effect), an exposure assessment and a risk characterisation.

17. The results obtained from a comparison of the exposure with the zero-effect concentration level for each of the active substances and substances of possible risk should be integrated in order to obtain a comprehensive assessment of the risk of the biocidal product. If no quantitative results are available, the results of the qualitative assessments will be integrated in a similar way.

18. The risk assessment shall determine:

a) The risk to humans and animals.

b) The risk to the environment.

(c) The measures necessary for the protection of human beings, animals and the environment during the normal use of the biocidal product and in the most unfavourable case.

19. In some cases, it may be decided that more data need to be available in order to complete a risk assessment. Any additional data requested shall be the minimum necessary to complete such risk assessment.

Effects on the human being:

20. The risk assessment shall take into account the following possible effects arising from the use of the biocidal product and the population that may be exposed.

21. The above effects are derived from the properties of the active substance and any substance of possible risk present in the biocidal product. These effects are: acute and chronic toxicity; irritation; corrosivity; sensitization; repeated dose toxicity; genotoxicity; carcinogenicity; reproductive toxicity; neurotoxicity; any other special properties of the substance active or potential risk; other effects derived from physico-chemical properties.

22. The populations mentioned above are: Professional users; non-professional users; human population exposed indirectly via the environment.

23. The identification of the risk shall examine the properties and potential adverse effects of the active substance and any substance of possible risk present in the biocidal product. If, as a result of the assessment, the biocidal product is classified according to the requirements of Article 19 of this Royal Decree, an assessment of the dose (concentration) response (effect), an assessment of the exposure and a characterization of the risk.

24. In cases where the relevant evidence of the identification of the hazards has been carried out in relation to a possible effect of an active substance or a substance of possible risk present in a biocidal product, without the results having taken to the classification of the biocidal product, it is not necessary to carry out the risk characterisation in relation to that effect unless other reasonable grounds of concern, e.g. adverse effects on the environment or waste, are given. unacceptable.

25. The competent authority shall apply paragraphs 26 to 29 when carrying out an assessment of the dose (concentration) response (effect) of an active substance or potential risk present in a biocidal product.

26. The dose-response ratio for each active substance or substance of possible risk shall be assessed for repeated dose toxicity and toxicity for reproduction, and, where possible, the NOAEL (level without delay) shall be assessed. observed adverse effect).

If it is not possible to determine the NOAEL, the LOAEL (the lowest level of adverse effect observed) will be found.

27. As regards acute toxicity, corrosivity and irritation, it is not usually possible to establish a NOAEL or LOAEL based on the results of the tests carried out in accordance with the requirements of the Royal Decree. For acute toxicity, the LD50 (median lethal dose) or CL50 (median lethal concentration) or, when the fixed dose procedure has been used, the discriminant dose will be calculated. For other purposes, it is sufficient to determine whether the active substance or substance of potential risk has an intrinsic capacity to cause such effects during the use of the product.

28. As regards genotoxicity and carcinogenicity, it is sufficient to determine whether the active substance or substance of possible risk has an intrinsic capacity to cause such effects during the use of the biocidal product. However, if it can be demonstrated that an active substance or substance of possible risk identified as a carcinogen is not genotoxic, it is appropriate to determine a NOAEL or LOAEL as described in paragraph 26.

29. With regard to skin and respiratory sensitisation, there is no consensus on the possibility of determining a concentration below which adverse effects on a given subject are unlikely to occur in a given substance, it is sufficient to assess whether the active substance or potential risk has the intrinsic capacity to cause such effects during the use of the biocidal product.

30. Where data on toxicity resulting from human exposure observations are available, such as data from the manufacture, poison centres or epidemiology studies, particular attention shall be given to the data to the perform the risk assessment.

31. An exposure assessment shall be made in each of the human populations (professional users, non-professional users and the population indirectly exposed via the environment) where there is or is reasonable to assume that there will be an exposure to the biocide. The objective of the assessment shall be the quantitative or qualitative calculation of the dose/concentration of each active substance or substance of potential risk to which the population is or may be exposed during the use of the biocidal product.

32. The assessment of the exposure shall be based on the information in the technical file provided in accordance with Article 8 of this Royal Decree and on any other available and relevant information.

To be taken into account, in particular, as appropriate:

The exposure data measured in an appropriate manner; the manner in which the product is marketed; the type of biocidal product; the method and the rate of application; the physicochemical properties of the product; the likely routes of exposure; and the absorption potential; the frequency and duration of the exposure; the type and size of the specific populations exposed when such information is available.

33. In the performance of the exposure assessment, special attention should be paid to the data representative of the exposure, measured appropriately, to be available. If calculation methods are applied to establish exposure levels, appropriate models should be used.

Such models should:

a) Calculate all significant processes in the best possible way, taking into account realistic parameters and assumptions.

b) Submit to an analysis that takes into account possible elements of uncertainty.

c) Comprove reliably with measurements made in circumstances appropriate to the application of the model.

d) Adjusting to the conditions in the usage field.

The relevant data for the monitoring of use substances and similar exposure modes or similar properties should also be taken into account.

34. When a NOAEL or LOAEL has been determined for any of the effects referred to in paragraph 21, the risk characterisation shall result in the comparison of the NOAEL or LOAEL with the dose/concentration assessment to which the NOAEL or LOAEL is exposed. population. If the NOAEL or LOAEL cannot be established, a qualitative comparison will be made.

Effects on animals:

35. Following the same relevant principles as described in the paragraph dealing with the effects on the human being, the competent authority shall consider the risk of the biocidal product present for the animals.

Effects on the environment:

36. The risk assessment shall take into account any adverse effects caused by the use of the biocidal product in any of the three environmental compartments, air, soil, water (including sediment) and biota.

37. The hazard identification shall examine the properties and potential adverse effects of the active substance and substances of potential risk present in a biocidal product. If the results obtained lead to the classification of the biocidal product in accordance with the requirements of this Royal Decree, the assessment of the dose (concentration) response (effect), exposure assessment and risk characterization.

38. In those cases where appropriate tests have been carried out for the identification of hazards related to a particular potential effect of an active substance or a substance of possible risk present in a biocidal product, but without a classification of the biocidal product shall not be necessary to make the risk characterisation related to this effect, unless there are other reasonable grounds for alarm. These reasons may be derived from the properties and effects of any active substance or substance of possible risk present in a biocidal product, in particular: elements indicating a potential for bioaccumulation; the characteristics of persistence ; the shape of the toxicity/time curve in the ecotoxicity test; indications of other adverse effects based on toxicity studies, e.g. classification as genotoxic; data on substances of analogous structure; effects endocrine.

39. An assessment of the dose (concentration) response (effect) will be performed to predict the concentration of the substance below which adverse effects are not expected in the environmental compartment concerned. The assessment shall be carried out for each active substance and substance of possible risk present in a biocidal product. This concentration is known as the predicted no-effect concentration (PNEC).

However, in some cases, it may not be possible to establish a PNEC and a qualitative estimate of the dose (concentration) response (effect) should be made.

40. The PNEC shall be determined on the basis of data on the effects on organisms and ecotoxicity studies, presented as determined by Article 7 of the Royal Decree. The PNEC shall be calculated by applying an assessment factor to the values resulting from testing with organisms, e.g. DL5O (median lethal dose), CL50 (median lethal concentration), EC50 (medium effective concentration), IC50 (concentration) produces 50 per 100 inhibition of a given parameter, e.g. growth), NOEL/C (level/concentration without observed effect) or LOEL/C (level/concentration with minimal observed effect).

41. An assessment factor is an expression of the degree of uncertainty in the extrapolation of data from an assay with a limited number of species to the actual environment. Therefore, in general, the broader the data and the longer the duration of the tests, the lower the degree of uncertainty and the magnitude of the assessment factor.

The specifications for the assessment factors shall be drawn up in the notes relating to the technical guidance which, for this purpose, shall be based, in particular, on the indications given in Article 4 and Annex X to the Royal Decree 363/1995 of 10 March 1995 approving the Regulation on the Notification of New Substances and Classification, Packaging and Labelling of Dangerous Substances.

42. An exposure assessment shall be carried out for each environmental compartment to predict the likely concentration of each active substance or potential risk present in the biocidal product. This concentration is known as the predicted environmental concentration (PEC). However, in some cases it may not be possible to establish a PEC and a qualitative estimate of the exposure will have to be made then.

43. A SGP or, where necessary, a qualitative estimate of the exposure in the case of those environmental compartments where emissions, discharges, removals or removals are reasonably foreseeable, will only need to be determined. distributions, including any relevant contribution of material treated with biocidal products.

44. PEC or the qualitative estimate of the exposure shall be calculated taking into account, in particular and where appropriate: the appropriate exposure data; the manner of placing on the market of the product; the type of biocidal product; the method and the rate of application; physicochemical properties; degradation/transformation products; probable paths of arrival in the environmental compartments and potential for adsorption/desorption and degradation; frequency and duration of exposure.

45. In the performance of the exposure assessment, special attention should be paid to the data representative of the exposure, measured appropriately, to be available. If calculation methods are applied, appropriate models should be used to establish the exposure levels. The characteristics of those models shall be in accordance with paragraph 33.

Where appropriate, account shall also be taken of relevant data on the monitoring of use substances and similar exposure modes or similar properties on a case by case basis.

46. In each given environmental compartment, the risk characterisation shall, as far as possible, lead to a comparison of the PEC to the PNEC, so that a PEC/PNEC ratio can be obtained.

47. If it has not been possible to obtain the PEC/PNEC ratio, the risk characterisation shall include a qualitative assessment of the probability that an effect may occur or may occur under current or expected exposure conditions.

Unacceptable effects:

48. Data shall be submitted to the competent authority, which shall carry out its assessment, to determine whether the biocidal product does not cause unnecessary suffering in its effect on the target vertebrates. This shall include an assessment of the mechanism by which the effect is obtained, as well as the effects observed in the behaviour and health of the vertebrates to which it is intended; if the effect is the death of the target vertebrate, they must evaluate the time required for that death to occur and the conditions in which it occurs.

49. The Member State shall assess, where appropriate, the possibility that the body to which it is intended to develop resistance to an active substance of the biocidal product.

50. If there is evidence of the possible presence of any other unacceptable effect, the competent authority shall assess the possibility of such effects, such as an adverse reaction to closures and accessories used with the wood after the application of a wood preservative.

Efficacy:

51. Data should be submitted and evaluated to corroborate claims on the efficacy of the biocidal product. The data submitted by the applicant or held by the competent authority should demonstrate the effectiveness of the biocidal product with the target organisms in normal use in accordance with the conditions of authorisation.

52. The tests shall be carried out in accordance with the Community guidelines, if applicable and available. Where appropriate, other methods may be followed which are listed in the list below. If the corresponding field acceptable data exists, these can be followed.

a) ISO, CEN or other international standards method.

b) Method of national rules.

c) Method of industrial standards (accepted by the competent authority).

d) Manufacturer's method of standards (accepted by the Competent Authority).

e) Data on the development of the biocidal product (accepted by the competent authority);

Summary:

53. In each of the fields where a risk assessment has been carried out, that is to say, effects on the human, animal and environment, the competent authority shall integrate the results obtained in respect of the active substance with the obtained in respect of any substance of possible risk for the preparation of a comprehensive assessment of the biocidal product itself. All possible synergistic effects of the active substances and possible risk of the biocidal product shall be taken into account.

54. For biocidal products containing more than one active substance, adverse effects shall also be combined to obtain the overall effects of the biocidal product itself.

Adoption of decisions

General principles:

55. Without prejudice to paragraph 96, the competent authority shall adopt the decision on the authorisation of use of the biocidal product after integrating the risks arising from each active substance with the risks arising from each substance of possible present risk. in the biocidal product.

Risk assessments shall cover the normal use of the biocidal product and the most unfavourable realistic case, including any relevant question of the disposal of both the biocidal product itself and any material treated with it.

56. When adopting the decision on the authorisation, the competent authority shall opt for one of the following conclusions for each product type and for each area of use of the biocidal product for which the application has been submitted:

1) The biocidal product cannot be authorized.

2) The biocidal product may be authorized under certain conditions/restrictions.

3) More data is required to proceed with your authorization.

57. If the conclusion adopted by the competent authority is that more data or more information is required to take the decision concerning the authorisation, the need for such data or information should be justified. Such additional data or information shall be the minimum necessary to carry out a new risk assessment.

58. The Member State shall comply with the principles of mutual recognition in accordance with Article 4 of this Royal Decree.

59. The competent authority shall apply the rules relating to the concept of 'framework formulations' when adopting a decision for the authorisation of a biocidal product.

60. The competent authority shall apply the rules concerning the concept of 'low risk' products when adopting a decision to authorise the biocidal product.

61. The competent authority shall only grant authorisation to biocidal products which, when used in accordance with their conditions of authorisation, do not present an unacceptable risk to humans, animals or the environment, effective and contain active substances permitted in the Community as members of such biocidal products.

62. When granting authorisations, the competent authority shall, where appropriate, impose conditions or restrictions the nature and severity of which shall be established on the basis of the nature and extent of the advantages and risks envisaged in relation to the use of the biocidal.

63. In decision-making, the competent authority shall take into account the following: the results of the risk assessment, in particular the relationship between exposure and effect; the nature and severity of the effect; the risk management that may be apply; the scope of use of the biocidal product; the efficacy of the biocidal product; the physical properties of the biocidal product; the advantages of the use of the biocidal product.

64. When adopting a decision on the authorisation of a biocidal product, the competent authority shall take into account the uncertainty caused by the variability of the data used in the assessment and decision-making process.

65. The competent authority shall prescribe the correct use of the biocidal product. This correct use shall consist of an effective dose of application and, where possible, to minimise the use of biocidal products.

66. Before granting an authorisation, the competent authority shall take the necessary measures to verify that the applicant proposes a product label and, where appropriate, the relevant safety data sheet for the biocidal product which:

a) Complies with the requirements of Articles 19 and 20 of this Royal Decree.

b) Contains information on the protection of users, as required by Community legislation on the protection of workers.

c) expressly specifies the conditions or restrictions according to which the biocidal product may or may not be used.

Before issuing an authorization, the competent authority will confirm that these requirements must be met.

67. The competent authority shall take the necessary measures to ensure that the applicant proposes a package and that, where appropriate, the proposed procedures for the destruction or decontamination of the biocidal product and its packaging or any other relevant material associated with the biocidal product are in accordance with the relevant regulatory provisions.

Effects on the human being:

68. The competent authority shall not authorise a biocidal product if the risk assessment confirms that, even in the most unfavourable scenario of its foreseeable application, the product presents an unacceptable risk to the human being.

69. When adopting the decision on the authorisation of a biocidal product, the competent authority shall take into account the possible effects on all human populations, i.e. professional users, non-professional users and persons exposed directly or indirectly via the environment.

70. The competent authority shall examine the relationship between the exposure and the effect and shall apply it to the adoption of the decision. Several factors are involved in the examination of this relationship and one of the most important factors is the nature of the adverse effect of the substance. These effects may be acute toxicity, irritation, corrosivity, sensitisation, repeated dose toxicity, genotoxicity, carcinogenicity, neurotoxicity, reproductive toxicity, together with the physicochemical properties, and any another adverse property of the active substance or possible risk.

71. The competent authority shall, as far as possible, compare the results obtained with those of previous risk assessments carried out on identical or similar effects, and shall act with an appropriate margin of safety when adopting its authorization decision.

An adequate margin of safety is typically 100, but a higher or lower safety margin may be adequate depending on, among other things, the nature of the critical toxicological effect.

72. The competent authority may, if necessary, impose as a condition for the authorisation the use of personal protective equipment such as respirators, masks, protective clothing, gloves and safety goggles to reduce the exposure of professional users, who must readily dispose of such equipment.

73. If the use of personal protective equipment is the only possible method of reducing the exposure of non-professional users, the product will not normally be authorised.

74. If the relationship between the exposure and the effect cannot be reduced to an acceptable level, the competent authority may not grant authorisation for the biocidal product.

75. No classified biocidal product, as referred to in Article 19 (1) of this Royal Decree, as toxic, very toxic or as a carcinogen or mutagenic of categories 1 or 2, or classified as toxic to the general public, shall be authorised for the use of the general public. the reproduction of categories 1 or 2.

Effects on animals:

76. The competent authority shall not authorise a biocidal product if the risk assessment confirms that, under normal authorisation, the product presents an unacceptable risk to the animals to which it is not intended.

77. Using the same relevant criteria as described in the part dealing with the effects on the human being, the competent authority shall take into account the risks presented by the biocidal product to the animals in taking the decision concerning the authorisation of the a biocidal product.

Effects on the environment:

78. The competent authority shall not authorise a biocidal product if the risk assessment confirms that the active substance or any substance of potential risk, or any degradation or reaction product, presents an unacceptable risk to any of the compartments of the environment, water (including sediments), soil and air. The risk assessment shall be included here for the bodies to which it is not intended for such compartments.

When considering whether there is an unacceptable risk, the competent authority, having to make a final decision in accordance with point 96, shall take into account the criteria of points 81 to 91.

79. The basic tool used in the adoption of the decision is the PEC/PNEC ratio, or, if it is not available, a qualitative estimate. Due attention should be paid to the accuracy of this relationship due to the variability of the data used in the measurement of concentration and estimation.

When determining the PEC, the most appropriate model should be used taking into account what is occurring with the biocide in the environment and its behavior in that environment.

80. In each given environmental compartment, if the PEC/PNEC ratio is equal to or less than the unit, the risk characterisation shall be that no further information or new evidence is required.

If the relationship is higher than the unit, the competent authority shall judge based on the magnitude of the relationship and other relevant factors, whether further information or new evidence is required to clarify the matter or whether they are necessary risk mitigation measures or if no authorisation can be granted to the product.

The relevant factors to be considered are those mentioned above in paragraph 38.

Water:

81. The competent authority shall not authorise a biocidal product if, under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of possible risk and of the relevant metabolites or degradation products or reaction in water (or its sediments) has an unacceptable consequence on species not intended for the aquatic, marine or estuary environment unless it is scientifically proven that there is no unacceptable effect under relevant field conditions.

82. The competent authority shall not authorise a biocidal product if, under the proposed conditions of use, the foreseeable concentration of the active substance or any substance of possible risk, or of the relevant metabolites or degradation products in the surface water exceeds the lowest of the following concentrations:

(a) The maximum permissible concentration laid down in the current legislation on the quality of water intended for human consumption.

(b) The maximum concentration as set out in accordance with the procedure to include the active substance in Annex I, IA or IB to this Royal Decree on the basis of the relevant data, in particular the data Toxicological, unless it is scientifically proven that such lower concentration is not exceeded in relevant field conditions.

83. The competent authority shall not authorise a biocidal product if the foreseeable concentration of the active substance or any substance of possible risk, or of the relevant metabolites or degradation or reaction products present in the waters surface or sediment after use of the biocidal product under the proposed conditions of use:

(a) Supera, in the event that the surface waters of the potential application of biocidal product (or derived from it) are intended for the production of drinking water, the values established.

(b) By Council Directive 75 /440/EEC of 16 June 1975 on the quality required for surface water intended for the production of drinking water in the Member States, transposed into our national law Regulation of the Public Water Administration (Annex I); Order of 11 May 1988 on rivers. Basic quality characteristics to be maintained in the surface currents for the production of drinking water, Order of 15 May 1990, Aguas. It amends the Order of 11 May 1988, of basic quality characteristics to be maintained in the surface currents intended for the production of drinking water, Order of 30 November 1994, Water. It amends the Order of 11 May 1988 on basic quality characteristics to be maintained in the currents of surface fresh water intended for the production of drinking water, and Royal Decree 1541/1994, Aguas. It amends Annex 1 to the Regulation of the Public Administration of Water and Hydrological Planning, approved by Royal Decree 927/1988 of 29 July.

c) By the current regulations on water quality intended for human consumption, Royal Decree 1138/1990 of 14 September, approving the Technical-Health Regulations for the supply and quality control of water drinking water for public consumption.

(d) presents an effect deemed unacceptable for species to which it is not intended, unless it is scientifically proven that in relevant field conditions this concentration is not exceeded.

84. The instructions for the use of the proposed biocidal product, including the procedure for cleaning the application utensils, should minimise the occurrence of accidental contamination of water or its sediments.

Soil:

85. Where unacceptable soil contamination may occur, the Member State shall not authorise a biocidal product if, after the use of the product under the conditions laid down, the active substances or possible risk substances in the substance are used during tests in the The field persists in soil for more than one year, or during laboratory testing, forms non-extractable residues in amounts greater than 70 per 100 of the initial dose after a hundred days, with a mineralization rate of less than 5 per cent. 100 in 100 days, consequences or unacceptable effects on organisms to which it is not intended, unless this is scientifically demonstrated that, under field conditions, there is no unacceptable accumulation in the soil.

Air:

86. The competent authority shall not authorise a biocidal product if there is a foreseeable possibility of unacceptable effects on the atmospheric compartment unless it is scientifically demonstrated that there are no unacceptable effects under conditions of relevant field.

Effects on the organisms to which it is not intended:

87. The competent authority shall not authorise a biocidal product if there is a reasonable and predictable possibility that the organisms to which it is not intended are exposed to the biocidal product if, in respect of any active substance or possible risk:

The PEC/PNEC ratio is higher than the unit, unless it is clearly established in the risk assessment that there are no unacceptable effects on the use of the biocidal product under the proposed conditions under the proposed conditions usage, or,

The bioconcentration factor (BCF) corresponding to the adipose tissues of the vertebrates to which it is intended is greater than the unit, unless it is clearly established in the risk assessment that, under field conditions, no the use of the biocidal product in the proposed conditions of use directly or indirectly results in unacceptable effects.

88. The competent authority shall not authorise a biocidal product if there is a reasonable and foreseeable possibility that aquatic organisms, including marine and estuary organisms, are exposed to the biocidal product if, for any active substance or possible risk in the included, the PEC/PNEC ratio is higher than the unit, unless it is clearly established in the risk assessment that, under field conditions, the viability of the aquatic organisms, including marine and marine organisms, estuary, is not threatened by the biocidal product under the proposed conditions of use; or of bioconcentration (FBC) is greater than 1,000 for readily biodegradable substances, or more than 100 for those which are not readily biodegradable, unless it is clearly established in the risk assessment that in field conditions there is no direct or indirect impact on the viability of the exposed organisms, including marine and estuary organisms, on the use of the biocidal product under the proposed conditions of use.

By way of derogation from this paragraph, the competent authority may, however, authorise an anti-fouling product used in maritime, commercial and public service vessels for a period of up to 10 years. from the date on which this Royal Decree enters into force, if an anti-fouling check cannot be carried out by other applicable means. When applying this provision, the competent authority shall take into account, where appropriate, the relevant resolutions and recommendations of the International Maritime Organisation (IMO).

89. The competent authority shall not authorise a biocidal product where there is a reasonably foreseeable possibility that micro-organisms in waste water treatment plants are exposed to the biocidal product if, because of any active substance or possible risk, corresponding metabolite, degradation or reaction of the product, the PEC/PNEC ratio is greater than 1, unless it is clearly established in the risk assessment that there is no unacceptable consequence, directly or indirectly, on the viability of such micro-organisms under field conditions.

Unacceptable effects:

90. If the development of resistance to the active substance of the biocidal product is foreseen, the competent authority shall take the necessary measures to minimise the consequences of such resistance. This may lead to the modification of the conditions of authorisation, or even their rejection.

91. Authorisation shall only be granted for a biocidal product intended to control vertebrates when:

a) Death occurs simultaneously with the extinction of consciousness, or the appearance of suffering.

b) Death occurs immediately, or c) Vital functions are gradually reduced with no signs of apparent suffering.

For repelling products, the effect pursued shall be obtained without unnecessary suffering or pain from the vertebrate to which it is intended.

Efficacy:

92. The competent authority shall not authorise a biocidal product which does not have an acceptable efficacy when used in accordance with the conditions specified in the proposed label or with other conditions of authorisation.

93. The level, consistency and duration of the control or protection or other effects pursued should be similar, at least, to those derived from other appropriate reference products where such products exist, or to other means of control. In the absence of any reference product, the biocidal product should provide a defined level of control or protection in the proposed areas of use. The findings as to the performance of the biocidal product should be valid for all areas of use proposed in the competent authority, except where the proposed label prescribes that the biocidal product is intended for use in circumstances specific. The competent authority shall evaluate the dose response data generated in the tests (which shall include an untreated control) in which the dose is lower than the recommended proportion, in order to assess whether the recommended dose is the minimum required to achieve the desired effect.

Summary:

94. In each of the fields in which risk assessments have been carried out, that is to say, effects on the human, animal and environment, the competent authority shall integrate the conclusions to which it has been drawn. active substance and substances of possible risk to develop a comprehensive conclusion of the biocidal product itself. A summary of the assessment of effectiveness and unacceptable effects should also be made.

The result shall be a summary of: the effects of the biocidal product on the human being, the effects of the biocidal product on the animals, the effects of the biocidal product on the environment, the assessment of efficacy, the unacceptable effects.

Global integration of the findings

95. The competent authority shall integrate the conclusions reached with regard to the effects of the biocidal product on the three sectors concerned, the human being, the animals and the environment, in order to draw up a general conclusion on the effect of the biocidal product.

96. Before proceeding to the decision on the authorisation of a biocidal product, the competent authority shall take due account of any unacceptable effects of consideration, the effectiveness of the biocidal product and the advantages of its use.

97. The competent authority shall ultimately decide whether the authorisation of the biocidal product may be carried out and whether such authorisation should be subject to certain restrictions or conditions, in accordance with this Annex and the Royal Decree.