Royal Decree 1054 / 2002, Of 11 October, Which Regulates The Evaluation Process For The Registration, Authorisation And Marketing Of Biocides.

Original Language Title: Real Decreto 1054/2002, de 11 de octubre, por el que se regula el proceso de evaluación para el registro, autorización y comercialización de biocidas.

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The Royal Decree 3349/1983, of 30 November, approved the Reglamentación for the manufacture, marketing and use of pesticides, setting as a standard health commodity management in regard to public health, as well as the fixing of the requirements for the manufacture, marketing and use of pesticides, and the establishment of the bases for fixing the maximum residue limits all this in order to prevent accidents and poisonings and avoid or limit the dangers associated with its use, direct and indirect.

In addition, regulated the approval of different types of pesticides, which should continue enrolling in its respective official records: plant protection products as well as pesticides use livestock, in the Ministry of agriculture, fisheries and food, and those in use in the food industry and those of environmental use as well as use in personal hygiene and disinfectants material clinical and pharmaceutical and clinical and surgical environments , in the Ministry of health and consumption.

For registration of pesticides in their respective official records, the Royal Decree establishes that, as a prerequisite, be homologated aspects of danger to human health in accordance with the provisions contained in the same, task that is attributed to the General Directorate of public health, which corresponds to determine, among other things, classification, symbols and risk phrases to be included on the labelling as well as the acceptability of its use for domestic use.

Reglamentación for manufacturing, marketing and use of pesticides, through Royal Decree 162/1991, of 8 February, was modified in order to transpose the provisions of Directive 78/631/EEC, of 26 June on classification, packaging and labelling of dangerous preparations (pesticides), by introducing certain criteria for the classification of preparations of non-chemical nature and attributed to the Ministry of health and consumption competition promote the initiation of records to suspend or restrict the marketing of ready when you check that they pose a danger to human health or safety.

Equally, the Royal Decree 443/1994, of March 30, modified once more the aforementioned Reglamentación, to include pesticides for use in the food industry which should register in the register of the General direction of public health.

In addition, classification and identification of hazards and the risk of each substance and prepared must be done in accordance with provisions in the Royal Decree 363/1995, of 10 March, on the classification, packaging and labelling of dangerous substances, the Royal Decree 1078 / 1993, of 2 July, dangerous preparations above, Regulation (EEC) 793/1993 of the Council on evaluation and control of the risks of existing substances, and the Royal Decree 1406 / 1989, 10 November, by which impose limitations on marketing and use of certain substances and dangerous preparations, being the General Directorate of public health the competent authority in this matter.

For its part, the Royal Decree 1415 / 2000, July 21, establishes, in its article 11, to the General Directorate of quality and environmental evaluation of the Ministerio de Medio Ambiente shall be the competent authority for the environmental aspects.

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, harmonises European legislation on these products, previously known as non-agricultural pesticides. These biocidal products are necessary for the control of organisms that are harmful to human health and the animals, and for the control of organisms that cause damage to natural or manufactured products.

In addition, dated September 7, 2000, was adopted Regulation (EC) 1896 / 2000 of the Commission, which starts the first phase of the programme referred to in article 16.2 of the said directive.

To achieve, among other objectives, the free movement of such products in the territory of the community, while ensuring a high level of protection of human health, animals and the environment, the directive sets the procedures of authorization and registration, as well as a core set of common data for substances and biocides preparations. These common principles for the evaluation will be used to avoid risks to human health and the environment by the epidemic control, the mutual recognition between the Member States, the development of a Community list of active substances authorised as ingredients of biocides, 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 among other aspects, contributing to reduce to a minimum the number of animal tests and ensuring that the authorised biocidal products, when properly applied for the purpose intended, they are sufficiently effective and have no unacceptable effect on the organisms for which it is intended.

In order to comply to the operating principles that should govern the actions of the General Administration of the State, in accordance with article 3 of law 6/1997, of 14 April, of organization and functioning of the General Administration of the State, and specifically, the efficiency in the fulfilment of the objectives, efficiency in the allocation and use of public resources rationalization and agility of administrative procedures, and effective service to the citizens, as well as to facilitate the management of the directive, it has been considered appropriate to recast in a single record registration of different types of biocides.

Today, much of these activities develops the Directorate-General of public health and Management Center responsible for the management of the State functions in public health, in particular the activities of specific records of pesticide and public health notification of new substances, as well as the activities with them, in particular those relating to hazard and risk assessment and classification and labeling for human health.

In the same way, it develops the exclusive powers of the State in relation to dangerous preparations, limitation and prohibition of placing on the market of dangerous substances and risk to existing substances evaluation. It has also assigned functions on regulation of the sanitary control of chemical products and the management of environmental monitoring network.

Through this Royal Decree is incorporated into our domestic law the Directive 98/8/EC, with the exception of with regard to the establishment of a system of charges, which must be subject to regulation, in its essential elements, using a standard of legal rank, in compliance with the principle of legality in this matter laid down in the Constitution.

This Royal Decree is the basic rule and is run under the protection of article 149.1.16. ª and 23.ª of the Constitution and in accordance with the provisions of article 40, paragraphs 1, 2, 5 and 6, of the law 14/1986 of 25 April, General health.

In the drafting of this provision have been heard the autonomous communities, as well as the sectors concerned and it has issued its mandatory report the Interministerial Commission for food management.

By virtue, on the proposal of the Minister of health and Consumer Affairs and the Ministers of agriculture, fisheries and food and environment, prior approval from the Minister of public administration, in accordance with the Council of State and after deliberation by the Council of Ministers at its meeting of October 11, 2002, D I S P O N G O : Article 1. Object and scope of application.

1 this Royal Decree is intended to regulate: to) requirements for authorisation and the placing of biocidal products on the Spanish territory.

(b) the assessment of dangerousness and risk of biocidal products.

(c) the rules for the mutual recognition of authorisations and registrations of biocidal products in the territory of the European Union.

(d) the rules for the development of the positive list of active substances which may be used in biocidal products.

(2. This provision shall apply to biocidal products as defined in paragraph a) of article 2. Excluded from the scope of the present Royal Decree aspects below, which shall be governed by the specific regulations, as well as the defined products or entering the field of application of this norm specifies: a) medicaments for human use.

(b) medicinal products for veterinary use.

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

(d) flavourings for food and materials for their production-based products.

(e) food additives authorised for use in foodstuffs intended for human consumption.

(f) materials and articles intended to come into contact with foodstuffs.

(g) raw milk, heat-treated milk and milk-based products.

(h) the hygienic-sanitary rules concerning the production and the placing on the market of egg products.

(i) the health rules for the production and the placing on the market of fishery products.

(j) products used in animal nutrition, animal feed and medicated feedingstuffs.


(k) the cosmetic products.

(l) plant protection products.

(m) the conditions for granting temporary and limited derogations with respect to specific health community 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 of the relating to: a) limitations on the marketing and use of certain substances and dangerous preparations.

(b) the prohibition of marketing and use of plant protection products containing certain active substances.

(c) the export and import of certain dangerous chemicals.

(d) the protection of workers from the risks related to exposure to chemical, physical and biological agents at work. The implementation of measures to encourage improvements in the safety and health of workers at the workplace.

(e) deceptive advertising.

4. the present Royal Decree obliges manufacturers, importers, formulators, marketing companies and service companies which are thus determined by regulation, understanding as such, any physical or legal person performing services for the application of these products.

5. the provisions of article 19 shall not apply to the carriage of biocidal products by rail, highways, waterways, sea or air.

Article 2. Definitions.

A_efectos_de the present Royal Decree refers: to) biocides: the active substances and preparations containing one or more active substances, presented in the form in which are supplied to the user, intended to destroy, offset, neutralize, prevent action or exercise control from other areas on any organism harmful by chemical or biological means. Annex V contains an exhaustive list of twenty-three types of products and, within each of them, a series of indicative descriptions.

(b) low-risk biocidal products: biocidal products that only contain active substance as one or more of those included in annex IA and do not contain any substances of concern. In terms of use, the biocidal product will pose only a low risk to humans, animals and the environment.

(c) basic substances: substances which are listed in Annex IB and whose main use is not as pesticides, but have a minor as a biocide use, well directly, or in a product consisting of the substance and a simple diluent which is not, at the same time, a substance of concern and is not directly marketed for use as a biocide.

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

(e) possible risk substance: any substance that is not the active substance, which has an inherent capacity to produce adverse effects in humans, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to demonstrate such an effect. This type of substance, unless other possible risks, it must be classified as dangerous in accordance with Royal Decree 363/1995, and will be present in the biocidal product at a concentration such that the product should be considered dangerous, according to the Royal Decree 1078 / 1993.

(f) harmful organism: any organism whose presence is undesirable or having a harmful effect on humans, their activities or the products that uses or produces, or animals, or the environment.

(g) waste: one or more of the substances present in a biocidal product which constitute the remains of their use, including the metabolites of such substances and products resulting from its degradation or reaction.

(h) market: any supply, whether for consideration or free, or subsequent storage that other than storage followed by the expedition from 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 marketing for the purposes of this Royal Decree.

(i) authorization: the administrative act by which, upon presentation of an application by the applicant to the competent authority, authorises the commercialisation of a biocidal product.

(j) development framework: the specifications for a group of biocidal products intended for the same use and user type. This group of products must contain the same active substances with the same specifications, and its composition must only present variations on a biocidal product authorised above, which do not affect the level of risk of those nor to its effectiveness. Variation means tolerance of a reduction of the percentage of the active substance, and/or an alteration in percentage composition of one or more non-active substances and/or the replacement of one or more pigments, dyes or scents by others who have equal or lower risk and does not diminish its effectiveness.

(k) registration: the administrative act by which prior submission of a request by the applicant to the competent authority, and after verification by this that the dossier meets the relevant requirements of this Royal Decree, authorises the commercialisation of a low-risk biocidal product.

(l) letter of access: a document signed by the owner or owners of the relevant data protected under the provisions of this Royal Decree, which declares that such data may be used by the competent authority, for the purpose of granting an authorisation or a registration of the biocidal product.

(m) an adjuvant: substances such as surfactants, fluidizing, stabilizers and other to be useful in the preparation of biocidal products for their ability to properly modify the physical and chemical properties of the active ingredients.

(n) substances: chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurity deriving from the process used, excluding any solvent which may be separated without affecting the stability or changing its composition.

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

(o) research and scientific development: chemical investigations, analyses and scientific experiments conducted under controlled conditions. This definition includes the determination of intrinsic properties, performance and efficacy, as well as the scientific investigation related to product development.

(p) research and development of the production: the further development of a substance during which its fields of application, using pilot productions or production trials are tested.

Article 3. Authorization of marketing of biocides.

1 biocidal products may only be marketed and used in the national territory if they have been previously approved and registered in the official register of biocidal products of the direction General of public health of the Ministry of health and consumption, pursuant to article 26 of this Royal Decree.

2 Notwithstanding the provisions of the preceding paragraph: to) the low-risk biocidal products may be marketed and used after the presentation to the Directorate-General of public health of a dossier, in accordance with article 8.4, whenever register properly, in accordance with article 26 of the present Royal Decree.

(b) the basic substances may be marketed and used as a biocide when entered in Annex IB.

3 terms of resolution of requests: to) in the procedures relating to requests for permission, the Directorate-General of public health should decision and notified to the person concerned within a period of six months. With regard to the procedure, it will be the provisions of law 30/1992, of November 20, legal regime of public administrations and common administrative procedure, modified by the law 4/1999 of 13 January.

(b) for applications for biocidal products, requiring to be low-risk register, the Directorate-General of public health will have a period of sixty days to enact and notify the corresponding resolution.

4. the General Directorate of public health shall, upon request or may on its own initiative, and where relevant, establish a frame-formulation, which shall be communicated to the applicant when it grants an authorization for a particular biocidal product.

Without prejudice to the provisions of articles 8 and 12 of this Royal Decree and provided that the applicant has the right to access the formulation framework in the form of a letter of access, when a subsequent request for authorization for a new biocidal product is based on this frame-formulation, the General Directorate of public health shall take a decision on the matter within a period of sixty days.

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

6. without prejudice to the provisions of paragraph 1 of article 7, a biocidal product shall be authorised for a maximum period of ten years from the date of the first registration or reregistration of the active substance in annex I or IA for this type of product. The authorization period should not exceed the deadline specified for the active substance in those annexes. In the case of renewal of the authorisation of the biocidal product, this may be after checking still conditions imposed by paragraphs 1 and 2 of article 5 are met.


May be also granted renewal, if applicable, for the period of time required for the Directorate-General of public health to make the verification that such conditions are still met.

7. the biocidal products should be used properly, which will mean that the conditions laid down in article 5 and specified in article 19 in relation to the labelling met. Such use shall entail the application of appropriate measures physical, biological, chemical or other confined to the minimum necessary use of biocides. When using biocides in the workplace, their use will be in accordance with the rules on the protection of workers.

Article 4. Mutual recognition of authorisations and registrations.

1. without prejudice to the provisions of article 12, a biocidal product which has been authorised or registered in one Member State, will be authorized or registered before within one hundred twenty days or sixty days, respectively, from the receipt of the request in Spain, provided that the active substance of the biocidal product is included in annex I or IA and meets the requirements of annexes.

In the case of mutual recognition of authorisations, the application shall contain a summary of the dossier in accordance with paragraph a) of paragraph 3 of article 8 and section X of Annex IIB or section x of annex IVB, as appropriate, as well as a certified copy of the first authorisation granted.

For the mutual recognition of records of low-risk biocidal products, the application shall contain the requirements set out in paragraph 4 of article 8, except in what refers to the efficacy data, for which it is sufficient a summary; a certified copy of the first awarded record will likewise be necessary.

If the application relates to livestock use biocides, it will be forwarded, with the documentation presented, to the General Directorate for livestock, for the purpose of review and appraisal.

The authorisation may be subject also to provisions deriving from the application of other measures laid down in the regulations related to the conditions of distribution and use of biocidal products, designed to protect the health of distributors, users and workers concerned.

This mutual recognition procedure is understood without prejudice to regulated in the legal provisions aimed at protecting the health of workers.

2 If, in accordance with article 5, the General Directorate of public health determines that: a) the species for which the biocidal product is intended is not present in harmful quantities, b) shows a tolerance or unacceptable resistance of the organism to the biocidal product, or c) the relevant circumstances relating to the use of the biocidal product is intended (, as climate or the period of reproduction of the species for which it is intended, they differ significantly from the Member State in which is authorized or registered for the first time the biocidal product, and if unchanged authorization may present therefore unacceptable to human or environmental risks, it may require that the conditions referred to in paragraphs are included and) ((((, f), h), j) and l) of paragraph 2 of article 19 to the different circumstances, so that the requirements of article 5 are met.

3. the Directorate-General of public health may provisionally refuse registration of a biocidal product, registered by another Member State, if it does not comply with the definition in paragraph b) of article 2 and shall immediately inform the competent authority of that Member State. If within a maximum period of ninety days not be reached an agreement between the relevant authorities, the matter shall be sent to the Commission for a decision in accordance with the procedure laid down in the following section.

4. Notwithstanding the provisions of paragraphs 2 and 3 of this article, when the Directorate-General of public health consider that a biocidal product authorised by another Member State may not meet the conditions of paragraph 1 of article 5 and therefore proposes to refuse the authorisation or the registration or set limitations to the authorisation, shall notify the other Member States the applicant and the Commission. Provide also an explanatory document which shall include the name and specifications of the product and will explain the reasons why intends to refuse the authorisation or set limitations to it.

5. If the procedure of paragraph 4 leads to the confirmation or refusal of the authorisation or the registration by the competent Community bodies in the field of the European Union, the General Directorate of public health shall take a decision confirming or denying the authorization or registration in accordance with the decision taken by the Community institutions , and if necessary, will review its registration in accordance with the article 6.

6. However the provisions of paragraph 1 of this article, the General Directorate of public health may reject, if its decision is justified, the mutual recognition of authorisations granted for biocidal products of the types of product 15, 17 and 23 of annex V of this Royal Decree and must report its decision to the other Member States and the Commission.

Article 5. Conditions for the granting of an authorisation.

1 the General direction of public health shall authorize or register a biocidal product and registered it in the official registration of biocides when: to) substance or substances active on it are included in the lists in annex I or IA and all met the requirements that laid;

(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, taking into account: all normal conditions of use of the biocidal product, the use of the material treated with it, and the consequences of the use and disposal.

The biocidal product: 1 is sufficiently effective.

2nd do not have unacceptable effects on organisms for which it is intended, such as unacceptable resistance or cross-resistance or suffering and unnecessary pain for vertebrates.

3rd do not have unacceptable effects itself or as a result of its residues, on human or animal health, directly or indirectly (for example, by drinking water or foodstuffs intended for human consumption or animal, indoor air or consequences in the workplace), or in surface and ground waters.

4th has No unacceptable effects itself or as a result of its residues, on the environment, taking into account the destination and distribution therein, in particular the pollution of surface waters (including marine and estuary waters), drinking water and groundwater, and its impact on organisms other than those for which is intended.

c) can determine the nature and quantity of its active substances and, where appropriate, any toxicologically or ecotoxicologically significant, as well as its residues of toxicological or environmental significance, resulting from authorised uses, according to the relevant requirements in Annex IIA, IIB, IIIA, IIIB, IVA or IVB;

(d) its physical and chemical properties have been determined and deemed acceptable for the purposes of use, storage and transport of the product;

(e) has been previously assessed, with respect to the environmental aspects, by the General Directorate of quality and environmental evaluation of the Ministerio de Medio Ambiente, and there is a favourable in this regard;

(f) there is a favourable report from the Directorate General of Pharmacy and health products of the Ministry of health and consumption, in the case of biocidal products intended to be applied on the human body and in the area of health;

(g) there is a report mandatory and binding of the General direction of animal husbandry of the Ministry of agriculture, fishing and food in case of biocidal products for uses including the rancher is included.

2. a biocidal product classified according to paragraph 1 of article 19 as toxic, very toxic or carcinogenic or mutagenic, category 1 or 2 or toxic for reproduction category 1 or 2, not be authorised for marketing or the use by the public in general.

3. when issuing an authorisation, shall be taken into account the requirements in other standards or provisions relating to the conditions of use of the biocidal product and authorization and, in particular, which are intended to protect the health of distributors, users, workers and consumers, the animals, or the environment.

4. the authorization or registration and registration in the official registration of biocidal products will be conditioned to the fulfilment of the requirements laid down in paragraph 1 of this article and it shall determine the conditions of marketing and use necessary to ensure compliance.

Article 6. Review of an authorisation.

All authorization may be reviewed at any time, for example in the light of the new information received in accordance with article 14, when there is an indication that already does not comply with the conditions laid down in article 5. In this case, they may require additional information to the holder of the authorization or the applicant which had been granted a modification of the authorisation, pursuant to the provisions of article 7.

If necessary, the authorization must extend to complete the review as well as to provide additional information.

Article 7. Revocation or modification of an authorisation.

1 an authorization will be revoked if:


((a) the active substance is no longer included in annex I or IA, in accordance with paragraph a) of paragraph 1 of article 5.

(b) already the conditions of paragraph 1 of article 5 are not met.

c) is discovered containing elements false or misleading information in virtue of which the authorisation was granted.

(d) the holder of the authorization request and indicate the reasons for the revocation.

2. when the General Directorate of public health deems necessary to revoke an authorization, it shall inform the authorisation holder and will open a period of audience. Asi_mismo, without prejudice to the provisions of the Royal Decree 1406 / 1989, 10 November, by which impose restrictions on the marketing and use of certain substances and preparations dangerous, and in paragraph a) of paragraph 1 of this article, shall be granted for the disposal or for the storage, marketing and use of stocks of the product , a period, whose duration will depend on the reason for the revocation.

3. According to the evolution of scientific and technical knowledge and in order to protect human health, the General Directorate of public health, where it considers it necessary, you may modify the conditions of use of an authorisation and, in particular, the form of use or the amounts to be used, shall inform the authorisation holder and will open a period of audience.

You can also modify an authorization if the holder of the authorization requests it and States the reasons for the modification.

4 where the Directorate-General for quality and environmental assessment is deemed necessary in the scope of their powers, according to the evolution of scientific and technical knowledge and to protect the environment, revoke or modify the conditions of use of an authorisation, shall notify the General Directorate of public health, who shall report the same to the holder of the authorization and will open a period of audience.

5 when the modification proposed refers to an enlargement of the use, the General Directorate of public health will expand the approval with the conditions to which the active substance according to annex I or IA is subject.

6 when the proposed modification of an authorisation involves changes in the conditions that the active substance in annex I or IA is subject, such changes were only made after the evaluation of the active substance with respect to the proposed changes, in accordance with the procedures laid down in article 11.

7. when the General Directorate for Pharmacy and medical devices or the General Directorate for livestock deem necessary in the field of its competences, according to the evolution of scientific and technical knowledge, revoke or modify the conditions of use of an authorisation, shall notify it the General Directorate of public health, who shall report the same to the holder of the authorization and will open a period of audience. Likewise, in amendments or revocations of products authorised biocidal products, which were informed by the General Directorate for Pharmacy and medical devices or by the General Directorate for livestock, it is necessary to also having the mandatory report of these management centres in connection with the modification or proposed revocation.

8. only be granted modifications if it has been found that they are still fulfilling the conditions required in article 5.

Article 8. Requirements for the authorization and registration.

1. the application for approval will be done by or on behalf of the person responsible for first placing of a biocidal product and you will be directed to the Directorate-General of public health.

2. applicants will have a permanent office in a country of the European Union.

3 the applicant for an authorization shall provide: a) a dossier or a letter of access of the biocidal product, which, according to scientific and technical knowledge at the time, to respond to the requirements of annex IVB or Annex IIB and, when specified, the relevant parts of Annex IIIB, and b) for each of the active substances of biocidal product , a dossier or a letter of access that meets the requirements of annex IVA or Annex IIA and, where specified, the relevant parts of Annex IIIA.

4 Notwithstanding the paragraph to) of paragraph 3, for a low-risk biocidal product must be present a dossier with the following data: to) applicant: name, surname and address, manufacturers of the biocidal product and the active substances (names and addresses, including the headquarters of the manufacturer of the substance active), where appropriate, a letter of access to all the necessary information.

((b) name and composition of the biocidal product: trade name, complete composition, physical and chemical properties referred to in paragraph d) of paragraph 1 of article 5.

(c) intended use: type of product in accordance with annex V of this Royal Decree and field of use, category of users and method of use.

(d) data on effectiveness.

(e) analytical methods.

(f) classification, packaging and labelling, including a draft label, pursuant to article 19 of this provision.

(g) data sheet security pursuant to the provisions of the Royal Decree 1078 / 1993 or in the Royal Decree 363/1995.

5. the technical dossier will be sent to the Directorate-General of public health and shall include a description that is complete and detailed studies and the methods used or a bibliographical them reference and shall contain the information and results of the studies referred to in Annexes IVA and IVB or in Annexes IIA and IIB and When specified, the relevant parts of Annex IIIA and IIIB.

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

6. no need to provide information when not required by the nature of the biocidal product or the uses that is intended, or when it is scientifically or technically not possible to facilitate it, presenting, in these cases, a justification to the General Directorate of public health, such as the existence of a development framework that the applicant is entitled to know.

7. If, after the assessment of the dossier, it is considered that more information, is required including data and results of add-on trials, to evaluate the risks of the biocidal product, such information is required to the applicant. The computation of the maximum period of the procedure shall be suspended until the date of receipt of the information requested.

8. the name of the active substance shall be adjusted to the designations listed in the annex I of the regulation on the notification of new substances and the classification, packaging and labelling of dangerous substances, approved by the Royal Decree 363/1995, of 10 May. When the substances were not included in this annex, they shall comply with the European inventory of chemicals marketed existing (EINECS). If they are not included in it, given the common name of the International Organization for Standardization (ISO). If substances were not included in the latter, it is designated by its chemical designation according to the rules of the International Union of chemical pure and applied (IUPAC).

9. the tests must be conducted in accordance with provisions in the Royal Decree 822/1993, of May 28, which establishes the principles of good laboratory practice and in Royal Decree 223/1988 of March 14, on the protection of animals used for experimental and other scientific purposes, and in accordance with the methods listed in annex V of 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.

When a method is not suitable or is not described, justified and internationally recognized methods will be used.

10. However, when there are data prior to May 14, 2000 and are different from those laid down in annex V of the Royal Decree 363/1995, the Directorate-General of public health in coordination with the Directorate of quality and environmental assessment, decide, case by case, if the data is relevant for the purposes of this Royal Decree and if necessary further tests in accordance with the preceding paragraph taking into account, among other factors, the need to minimize tests on vertebrate animals.

11. the General Directorate of public health will open an administrative file for each application that will contain, at least, a copy of it, a record of the administrative decisions relating to this and the dossiers submitted pursuant to paragraph 3 of this article, along with a summary of the latter.

The Directorate-General of public health, at the request of the competent authorities of the Member States and the Commission, will provide these administrative records referred to in this paragraph, as well as all information necessary for full comprehension of applications and, if requested, they shall ensure that applicants provide a copy of the technical documentation referred to in paragraph 3 of this article.

12 applications submitted in accordance with this Royal Decree shall be written, 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 sold when:


(a) be lodged a dossier with the active substance not on the market prior to May 14, 2000, that meets the requirements of paragraph 1 of article 11 and is accompanied by a declaration that it is intended to be part of a biocidal product. These requirements shall not apply to substances that are to be used in research and development, in accordance with article 16.

(b) are classified, packaged and labelled pursuant to the provisions of the regulation on the notification of new substances and the classification, packaging and labelling of dangerous substances, approved by the Royal Decree 363/1995, of 10 May.

Article 10. Inclusion of a substance active in annexes I, IA or IB.

1 an active substance shall be included in annexes I, IA or IB for an initial period not exceeding ten years, when: to) biocidal products containing that active substance, b) the low-risk biocidal products, defined in paragraph b) of article 2, c) the substances as defined in paragraph c) article 2, meet the requirements of paragraphs b) (((, c), d) and e) of paragraph 1 of article 5, taking into account scientific and technical knowledge at the time and, where appropriate, the cumulative effects arising from the use of biocidal products containing the same active substances.

2. an active substance shall not be included in annex IA when is it classified, pursuant to Royal Decree 363/1995, as carcinogenic, mutagenic, toxic for reproduction, sensitising, or when is bioacumule and does not degrade easily.

When necessary, the inclusion of active substances in annex IA shall refer to the ranges of concentration between which the substance can be used.

3 the inclusion of an active substance in annexes I, IA or IB shall be conditioned, where appropriate: to) to requirements concerning: 1 the minimum degree of purity of the active substance, 2nd nature and maximum content of certain impurities, 3rd type of product that can be used, 4th mode and area of use , 5 designation of categories of users (e.g. industrial, professional or non-professional), 6 other particular conditions that result from the evaluation of the information, in accordance with this Royal Decree.

(b) to the establishment of: 1 an acceptable level of operator exposure (ÑÀÉÒ), if necessary, 2 where relevant, an acceptable daily intake (ADI) for humans and a maximum limit for residue (LMR), 3rd its fate and behaviour in the environment and its impact on organisms other than which is intended.

4. the inclusion of a substance active in annexes I, IA or IB shall be limited to those types of products listed in annex V of this provision, and which had presented data in accordance with article 8.

5. the inclusion of an active substance in annexes I, IA or IB may be renewed, one or more times, for periods not exceeding 10 years. The initial inclusion, as well as any renewed inclusion, may be reviewed at any time where there are indications that are not already meets any of the requirements referred to in paragraph 1 of this article. In your case, the renewal may be granted only for the time necessary to proceed with the review, upon request of renewal and shall be granted for a limited period to facilitate the new information referred to in paragraph 2 of article 11.

6 to) may be refused or removed the inclusion of an active substance in annex I or, where appropriate, in annex IA or IB: 1 if the evaluation of the substance pursuant to paragraph 2 of article 11 shows that in normal conditions that can be used in authorised biocidal products, continues to cause concern for the health or the environment , and 2nd if in said Annex already exists for the same type of product another active substance that, according to scientific and technical knowledge presents a risk significantly less for health or for the environment.

When considering the refusal or withdrawal for this cause, will be presented an evaluation of one or several alternative active substances which demonstrate that they can be used with a similar effect in the body that is intended, without practical or economic disadvantages to the user and without increased risk to health and the environment.

The evaluation will be pursuant to the procedure laid down in paragraph 2 of article 11.

(b) the refusal or withdrawal of a substance included in annex I and when appropriate of IA or IB, will take place under the following conditions: 1 the chemical diversity of the active substances should be adequate to minimise the occurrence of resistance in the body for which it is intended.

2nd should be applied only to active substances which, when used under normal conditions in authorised biocidal products, present a significantly different risk level.

3rd must be applied only to active substances used in products of the same type.

4th should be applied only after allowing, if necessary, of acquiring experience from use in practice when there already.

(c) the decision to withdraw a substance in annex I shall not have immediate effect, but it will be delayed up to a maximum period of four years from the date of the decision.

Article 11. Procedure for inclusion of a substance active in annexes I, IA or IB.

1 the General direction of public health will study the inclusion, or subsequent amendments to the inclusion, of an active substance in annexes I, IA or IB, when: a) an applicant has submitted: 1 a dossier for the active substance satisfying the requirements of annex IVA or Annex IIA and, when specified, the relevant parts of Annex IIIA.

2. A record at least one biocidal product containing the active substance satisfying the requirements of article 8, with the exception of its paragraph 4.

b) has verified the dossiers and consider that they meet 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 records and authorizes the applicant to send a summary thereof to the other Member States and the Commission.

2. in the period of the twelve months following the acceptance of records, an evaluation will be made and a copy will be sent to the Commission, the other Member States and to the applicant, together with a recommendation for inclusion of the active substance in annex I, IA or IB, or another type of decision, for further processing.

If the evaluation of dossiers is considered necessary information to make a full evaluation, required the requesting such information. This twelve month period is suspended from the date of issue of the request until the date of receipt of the information requested.

The Directorate-General of public health shall report its actions to the other Member States and the Commission, at the same time as the applicant.

3. the Directorate-General of public health, once we receive the records, may ask the Commission, accordingly, that the evaluation is conducted by other Member States.

Article 12. Use of data held by the General Directorate of public health by other applicants.

1 will not use the information referred to in article 8 of this Royal Decree, concerning an active substance, for the benefit of a second applicant or another subsequent applicant: a) unless the second or subsequent applicant has a written authorization in the form of a letter of access of the first applicant, in order to use this information ((, or b) when in the case of an active substance not on the market prior to May 14, 2000, even after fifteen years from the date of first inclusion in annex I or IA, or c) when in the case of an active substance, which is already marketed to date may 14, 2000, in which : 1 the period of protection shall be ten years from the 14 May 2000, for any information presented.

2nd the protection period shall be ten years from the date of inclusion of an active substance in annex I or IA, for information submitted for the first time in support of the first inclusion in the above annexes, of the active substance, good of a new type of product corresponding to the active substance.

(d) in the case of additional information concerning the modification of the requirements of the entry on Annex I or IA, or the maintenance of the inclusion in annex I or IA, and presented for the first time the period of protection will be of five years from the date of receipt of the additional information, unless said period ends before the fixed in paragraphs b) and (c)) (1) in which case be expanded so that the period of protection of reports completed at the same time.

2 will not use the information that is referenced in article 8 of this Royal Decree, concerning a biocide and a low-risk biocidal product, for the benefit of a second applicant or another subsequent applicant: a) unless the second or subsequent applicant has prior written consent in the form of a letter of access of the first applicant to be able to use this information (, or b) when in the case of a biocidal product containing an active substance that is not marketed prior to May 14, 2000, in which case the protection period shall be ten years from the date of first authorisation of marketing in a Member State, or


(c) in the case of a biocidal product containing an active substance, which is already marketed date of 14 May 2000, in which case the period of protection shall be: ten years from the date before 1 mentioned, for any information presented in accordance with the same Active 2 of ten years from the date of the inclusion of a substance in annex I or IA in the case of information presented for the first time in support of the first inclusion in the above annexes, of the active substance, either of a new kind of product for that active substance;

(d) in the case of data submitted for the first time and they affect a modification of the conditions of authorisation of a biocidal product or the maintenance of a substance active in annex I or IA, in which case the period of protection shall be five years from the date of receipt of the additional information; (unless said period ends before the fixed in paragraphs b) and (c)), in which case it will be extended so that end on the same date as those periods.

3. the General Directorate of public health may be sent to the Commission and to the Member States the information referred to in paragraphs 1 and 2 of this article, for the purposes of paragraph 6 of article 10.

Article 13. Cooperation in the use of data for second application and following.

1. in the case of a biocidal product that has already been authorised in accordance with articles 3 and 5, and without prejudice to the requirements of article 12, it may accept a second applicant or later to make reference to the data provided by the first applicant or subsequent applicants, provided they demonstrate that the biocidal product is similar and its active substances are the same as those authorized in the first place including the degree of purity and nature of impurities.

2 Notwithstanding the provisions of paragraph 3 of article 8: to) the applicant for authorisation for a biocidal product, before carrying out testing on vertebrate animals, shall obtain from the General Directorate of public health information about whether the biocidal product for which is going to submit the application is similar to other biocidal product which has been authorized, and the name and address of the holder or holders of the authorisation or previous authorizations.

The request for information shall be accompanied by documents certifying that the potential applicant intends to ask for an authorization on their own and that has available the rest of the information specified in paragraph 3 of article 8.

(b) the General Directorate of public health will provide the name and address of the holder or holders of former authorisations and shall communicate to the name and address of the new applicant, after that it intends to submit such application.

Among them, the holder or holders of former authorisations and the new applicant must share information. To this end, the Directorate-General of public health urge holders of such information to cooperate in the provision of the data required in order to avoid, if possible, the repetition of tests on vertebrate animals.

In case of disagreement, the Directorate-General of public health, in order to avoid repetition of testing on vertebrate animals, may adopt measures that force them to share the information, determining the procedure to be used at the same time, 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 its own initiative and under its responsibility, immediately notify in writing to the Directorate-General of public health information that relative to a known active substance or a biocidal product containing it and which may influence the continuity of authorisation, by notification in particular, the following: new knowledge or information on the effects of the active substance and the biocidal product on humans or the environment environment, changes in the source or composition of the active substance, changes in composition of a biocidal product, the development of resistance, changes in administrative or other aspects such as the type of packaging.

2. the General Directorate of public health immediately, communicated to the other Member States, the Commission and the competent national authorities, any information received concerning effects potentially hazardous to human health or the environment or the new composition of a biocidal product, its active substances, impurities, co-Formulants or residues.

Article 15. Exceptions to the requirements for marketing.

However 1 the provisions of articles 3 and 5, the General Directorate of public health, report of the DGs mentioned in article 5 sections 1.e), 1.f) and 1.g), may authorise, for a period not exceeding 120 days, the placing of biocidal products not complying with the requirements of this Royal Decree to use controlled and limited, if such a measure was necessary because of an unforeseen danger which cannot be contained by other means, reporting immediately to the other Member States and the Commission of the measures taken and their justification. The General Directorate of public health may extend the deadline or repeat the measure adopted, prior agreement of the competent Community bodies.

Also, at the request of the General Directorate for livestock, the Directorate-General of public health shall authorize the biocides that are necessary in case of emergency.

2 However the paragraph to) of paragraph 1 of article 5, and until an active substance is included in the Community list in annex I or IA, the General Directorate of public health may be authorised temporarily and for a period not exceeding three years, the commercialization of a biocidal product containing a substance activates not included in annexes whenever an active substance not on the market prior to May 14 2000, whose purpose is not research and development scientific and production processes. Such authorization may be granted only if, following the evaluation of records, in accordance with article 11, it is considered that the active substance satisfies the requirements of article 10 and that the biocidal product fulfils the conditions of paragraphs b), c), d), e) and if f) and g) of paragraph 1 of article 5 and any other Member State (, raises objections, pursuant to paragraph 2, subparagraph c), article 17.

The General Directorate of public health shall revoke the provisional authorisation when the competent Community bodies decide that formulated objections, if any, are founded, either because the records are not complete, or because the active substance does not meet the requirements specified in article 10.

If after the period of three years, not has completed the evaluation of dossiers for the inclusion of the active substance in annex I or IA, you can follow authorizing provisionally the product, for a period not exceeding one year, provided that the active substance satisfying the requirements of article 10, informing the other Member States and the Commission.

Article 16. Research and development.

However 1 the provisions of article 3, any test or experiment for the purpose of research and development involving the marketing of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product, not may carry out unless: to) in the case of scientific research and development, anyone interested keep a record with the identity of the biocidal product or active substance the labelling data, quantities supplied and names and addresses of those persons receiving the biocidal product or active substance, and all available data on possible effects on human or animal health or impact on the environment. This information must be available to the Directorate-General of public health.

((b) in the case of research and development in production processes, the information requested in paragraph a) is notified to the Directorate-General of public health, both for performing experiments or trials and carry out marketing.

2. an unauthorised biocidal product or an active substance for exclusive use in a biocidal product may not can be marketed for research and development purposes when there is a release to the environment during the same experiments or trials, except when once evaluated the data available to the Directorate-General of public health, with the report in advance of the General Directorate of quality and environmental assessment and , where appropriate, of the General Directorate for livestock, for aspects of their respective competencies and, when necessary, the non-binding report by the Ministry of science and technology has given an authorization that would limit the amounts that will be used, the areas which are to be treated, and conforms to the additional conditions that have been adopted to this effect.

3. any experiment or test which will be held in Spanish territory must obtain prior authorization from the Directorate-General of public health.

If proposed experiments mentioned in paragraphs 1 and 2 or trials may have harmful effects on the human or animal health or an unacceptable adverse influence to the environment, the General Directorate of public health may prohibit them or authorize them only in the conditions necessary to prevent those consequences.


4. paragraph 2 of this article shall not apply when granted the person concerned the right to perform certain experiments and tests, and have been set the conditions under which it must carry out.

5. the common criteria, in particular the maximum quantities of active substances or biocidal products that may be released during experiments, and the minimum information that must be submitted in accordance with paragraph 2 of this article, shall be adopted at Community level.

Article 17. Functions of the competent authority.

Shall be responsible for the Directorate-General of public health: 1. examine the information and documentation referred to reference the present Royal Decree, and may in addition: to) collect the applicant's trials and additional information, if after the evaluation of dossiers considers it is necessary information to make a complete evaluation of the.

b) requesting the administrative records concerning that paragraph 11 of article 8, as well as the information necessary for full comprehension of applications, including, if required, a copy of the technical documentation provided for in paragraph 3 of article 8.

(c) require that samples of the preparation and its components, as well as samples, models or projects of packaging, labels and package inserts are provided.

2 participate in the exchange of information between the Commission and the competent authorities of the States members, communicating and reporting: a) within the period of one month after the end of each quarter, of all biocidal products which have been authorised or registered or which has been refused, modified, renewed or cancelled an authorisation or a registration, indicating as a minimum : 1 the name and surname or business name of the applicant or the holder of the authorization or registration.

2. the trade name of the biocidal product.

3rd name and amount of each active substance which it contains, as well as the name and amount of each of the hazardous substances and their classification.

4th the product type and the use or uses for which it is authorised.

5 the type of formulation.

6 proposed residue limits that are determined.

7th the conditions of the authorisation and where relevant, the reasons for the modification or cancellation of an authorization.

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

(b) reject the mutual recognition of authorisations granted for 15 biocidal product types, 17 and 23 of annex V of the present Royal Decree.

((c) without unjustified delay, the competent authority responsible for the evaluation of dossiers, as well as the Commission and the other Member States, when you receive the summary of the records pursuant to paragraph b) of paragraph 1 of article 11 and paragraph 2 of article 15 and has legitimate reason to believe that it is incomplete.

d) when because of an unforeseen danger which cannot be contained by other means, to authorize for use controlled and limited, for a period not exceeding hundred twenty days, the marketing of biocidal products not complying with the requirements of this Royal Decree.

(e) a yearly list of the biocidal products authorised or registered, the other Member States and the Commission.

(f) on your actions in this matter, as well as any intoxication due to biocides, after the 14 May 2000, every three years the Commission, before 30 November.

3. report to the Commission, to the competent authorities and to the applicant when it proposes to refuse the authorisation or the registration or set limitations to the permission under certain circumstances, for a biocidal product authorised by another Member State under the terms laid down in article 4(4).

4. send a copy of the administrative records after their acceptance to the Commission, the Member States and the applicant with recommendations and decisions it deems appropriate.

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

6 collect, if it is deemed appropriate, collaboration and scientific expert advice and, where appropriate, establish working groups for the study of the records.

7 ensure the inclusion or not of an active substance in annexes I, IA or IB, granted, modified or cancelled, as appropriate, the authorisations or, where appropriate, the registrations for biocidal products containing those active substances, and comply with the provisions of this Royal Decree.

8 establish, where appropriate, models and standard systems of corresponding requests for the submission of the dossier for authorisation and registration documents.

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

10. develop basic legislation aimed at the harmonization of the health policy of the autonomous communities in matters of surveillance and control of biocidal products.

11 sent to the Directorates-General for quality and environmental evaluation, pharmacy and health products, and livestock, the technical documentation required for the issuance of reports, as well as any information that affects them.

(Will be functions of the Directorate-General for quality and environmental assessment, and where appropriate, of the General Directorate for Pharmacy and medical devices and the Directorate General of livestock, those specified in paragraphs 1.a) and (b)), 6, 7 and 10 of this article, within the scope of their respective competencies, collaborating with the Directorate-General of public health for the performance of the functions mentioned above.

The General Directorate for livestock shall be the competent authority to carry out the evaluation of safety and efficacy of the biocides within its competence.

Article 18. Confidentiality.

1. Notwithstanding provisions in law 38/1995 of 12 December, on the right of access to information in the field of environment, an applicant may indicate the information that may be considered sensitive from the commercial point of view and whose dissemination could result in commercial or industrial injury and that, therefore, you want to be sensitive with respect to any person who is not the competent authority or the Commission. A full justification shall be required in each case. Without prejudice to the provisions in paragraph 3 of this article and in Royal Decree 363/1995 and 1078 / 1993, the Directorate-General of public health shall take the necessary measures to ensure the confidentiality of the composition of the formulations of a product if the applicant so requests.

2. the Directorate-General of public health, when it receives the request, it shall decide, on the basis of the documentary evidence submitted by the applicant, the information to be considered confidential pursuant to paragraph 1.

The information considered confidential by the Department of public health will be treated as such by the other competent authorities of the Member States and the Commission. Likewise, the Directorate-General of public health will treat as confidential information considered as such by the competent authorities of the States members and the Commission.

3 once the authorisation has been issued in any case will have confidential: a) the name and address of the applicant.

(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 the content of the substance or active substances in the biocidal product, not the name of the biocidal product.

(e) the names of other substances which are considered dangerous as laid down in the Royal Decree 363/1995, and which contribute to the classification of the product.

(f) physical and chemical data concerning the active substance and the biocidal product.

(g) any method used for the active substance or biocidal product harmless.

(h) summary of the results of the trials required article 8 to determine the effectiveness of the product or substance and its effects on humans, animals and the environment, as well as its ability to promote resistance, if necessary.

(i) the methods and precautions recommended to reduce the risk due to handling, storage, transportation, use, fire and other risks.

(j) safety data sheets.

k) methods of analysis referred to in paragraph c) of paragraph 1 of article 5.

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

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

(n) first aid that must be dispensed and the medical advice that should be given in the event that damage to people.

If the applicant, manufacturer or importer of the biocidal product or active substance subsequently revealed information that was confidential, he must inform the Directorate-General of public health.

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

1. biocidal products shall be classified and shall be packaged according to the regulation of preparations dangerous, approved by the Royal Decree 1078 / 1993.

In addition, the products that are available to the public in general and may be mistaken for food, drink or feedingstuff, shall contain components that discourage their consumption and shall be packaged in such a way that the possibility of such confusion is reduced to a minimum. This requirement may be required in the authorisation procedure for those other professional use biocides whose characteristics so require it.


2. biocidal products shall be labelled according to the provisions of the regulation of preparations dangerous, approved by the Royal Decree 1078 / 1993. Labels shall not be misleading or give an exaggerated picture of the product, and not to mention, in any case, the indications 'low-risk biocidal product', 'non-toxic', 'harmless', or similar warnings. In addition, the label will show clearly and indelibly the following: to) identity of every active substance and its concentration in metric units.

(b) number of authorization granted to the biocidal product by the Directorate-General of public health.

(c) the type of preparation.

(d) uses for which the biocidal product (for example, guard for wood preservation, disinfection, surface biocide, anti-fouling, etc.) is authorised.

(e) instructions for use and the dose rate, expressed in metric units, for each use provided for under the terms of the authorization.

(f) details of likely direct or indirect adverse effects and any directions for first aid.

(g) the phrase "Read accompanying instructions before use", where it accompanied by a leaflet.

(h) instructions for disposal secure of the biocidal product and its packaging, including, where relevant, any prohibition on reuse of packaging.

(i) the number or the batch designation of the preparation and the date relevant to normal conditions of storage.

(j) the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product, where appropriate; the time interval to be observed between application and the next use of the product treated or next access to human beings or animals to the area affected by the biocide treatment, where appropriate; including details on media and decontamination measures and duration of necessary ventilation of treated areas; details on how to properly clean the equipment; details on the necessary preventive measures during use, storage and transport (for example, clothing and personal protective equipment, measures for protection against fire, protection of furniture, transportation of food or feed and instructions to prevent the exposure of animals).

And, where appropriate: k) the categories of users to which the biocidal product is restricted.

(l) information on any specific danger to the environment, in particular with regard to the protection of the organisms of the organism for which it is intended and to avoid contamination of the water.

(m) for microbiological biocidal products, labelling requirements established in accordance with the provisions in Royal Decree 664/1997, of May 12, on the protection of workers from the risks related to exposure to biological agents at work.

The General direction of public health will require that the requirements of the paragraph to), b), d) and, where appropriate, g) and k) are always indicated on the label of the product and allow that the requirements of paragraphs c), e), f), h), i), j) and l) of this section are listed elsewhere in the container or in a booklet which forms an integral part of the container considering that this information is part of the label for the purposes of this Royal Decree.

3 when a biocide identified as insecticide, acaricide and Rodenticide, avicide or molluscicide is authorised pursuant to this provision and on classification, packaging and labelling in accordance with the Reglamentación de pesticides, approved by the Royal Decree 3349/1983 and subsequent amendments, the General Directorate of public health may be permitted to make changes to the packaging and labelling of the product that may be necessary as a result of these provisions provided it does not come into conflict with the conditions of a permit issued pursuant to this Royal Decree.

4. the General Directorate of public health may require that samples, models or projects of packaging, labels and package inserts are supplied.

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

Article 20. Safety data sheet.

To ensure a specific information system that allows the users of professional and industrial biocides and, where appropriate, other users, to take the necessary measures for the protection of human health and the environment both for hygiene and safety in the workplace, a data sheet of each marketed product that manufacturers or persons in charge of the marketing will facilitate will be used. A copy of it will be delivered to the Directorate-General of public health, preferably by electronic means or in its defect in magnetic support. The Directorate-General of public health will send a copy of these chips of the products within its competence to the General Directorate for livestock.

The safety data sheet shall be drawn up in the following way: to) for biocidal products classified as dangerous in accordance with that established in article 10 of the Royal Decree 1078 / 1993.

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

Article 21. Advertising.

1. any advertising of a biocidal product shall be accompanied by the sentences 'use biocides safely. Always read the label and product information before use'. These phrases will clearly highlight within the set of advertising, and the word "biocide" may be replaced by the exact description of the type of product being advertised, for example, wood protectors, disinfectants, biocides for surface, anti-fouling products, etc.

2. the advertising of a biocidal product shall not present the product in a way that may induce to error in terms of the risks to man or the environment, or will include no mention as 'low-risk biocidal product', 'non-toxic', "harmless", or any similar indication.

Article 22. Prevention and toxicological control of biocidal products.

The Ministry of health and Consumer Affairs shall establish a system of health information and epidemiological toxicovigilancia designed to prevent, detect, diagnose and treat health problems relating to or caused by biocidal products.

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

The information system which will be coordinated by the General Directorate of public health will collect information and facilitate, where appropriate, to the following sources: a) records own of the Directorate-General of public health about biocides, dangerous new, existing, prepared chemicals and national and international scientific databases.

b) national network of surveillance, inspection and Control of chemical products and system of rapid exchange of information on chemical products (SIRIPQ).

(c) emergency services of the hospital network, clinical toxicology and primary care network units.

(d) health statistics established by the national health system and the National Institute of statistics.

(e) health authorities responsible for the toxicological control of the ministries of health of the autonomous communities.

(f) services of telephone toxicological information from 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 General Directorate of public health shall keep informed, by the fastest means possible, to the medical care units of the national system of health and those privately owned hospitals needing it, with regard to preventive and curative measures in case of emergency, with the collaboration of the National Institute of Toxicology toxicology information service through. The information provided, including the composition will be considered confidential.

Article 23. Administrative skills and competent authority: 1. powers of the General Administration of the State.

(a) in accordance with the provisions of article 18 paragraphs 6 and 11, article 19, article 23, article 24, article 25, article 26, article 27, article 28 and article 40, paragraphs 1, 2, 5 and 6 of the Act 14/1986 of 25 April, General health, and the Royal Decree 840/2002, of August 2nd, the Directorate-General of public health of the Ministry of health and consumption will be the authority for the provisions in This Royal Decree.

(b) in accordance with the Royal Decree 1415 / 2000, of July 21, article 11, the General Directorate of quality and environmental evaluation of the Ministerio de Medio Ambiente, shall be the competent authority for the environmental aspects.

(c) the Directorate-General of the Ministry of agriculture, fisheries and food livestock shall be the competent authority for animal safety-related aspects.

((d) for the exercise of these powers, and in order to correct application of the provisions of this Royal Decree, the Ministry of health and consumption, when necessary, will coordinate their performances with the remaining bodies of public administrations, providing, in accordance with the provisions of article 4.1. c) law 30/1992, of 26 November Legal regime of public administrations and common administrative procedure, as amended by law 4/1999, of 13 November, the information required for the exercise of their functions.

2. jurisdiction of the autonomous communities:


They correspond to the competent bodies of the autonomous communities the functions of monitoring, inspection and control of the correct performance of what is established in this Royal Decree, in their respective territories, as well as the exercise of the powers to impose penalties.

Article 24. Exchange of information with the autonomous communities.

1. the Ministry of health and consumption will supply to the autonomous communities guidelines, information or anything else which is available, so that they can properly exercise its functions. To do this you will use both the national network of surveillance, inspection and Control, as a system of rapid exchange of information on chemicals, which are established by the Directorate-General of public health of the Ministry of health and consumption, and the ministries of health of the autonomous communities, in the presentation of environmental health coordination bodies and the Committee on public health of the national system of health. You can also put into practice measures that are most appropriate to achieve the effective coordination of actions oriented to the prevention of risks, epidemiological surveillance and compliance with the provisions of this Royal Decree.

2. without prejudice to the measures of coordination and collaboration established, authorities of the autonomous communities shall annually inform the Ministry of health and consumption of the activities that are carried out to ensure the application of this provision.

3. the Ministry of health and consumption, shall keep informed the Ministry of agriculture, fisheries and food on biocidal products of livestock use, in order to facilitate its task of coordination with the autonomous communities.

Article 25. Safeguard clause.

When 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 consumption and, where appropriate, when appropriate, in coordination with the Ministry of environment and/or Ministry of agriculture, fisheries and food for aspects of their respective competencies You can restrict or temporarily ban the use or sale of that product. The Ministry of health and Consumer Affairs shall forthwith to the Commission and to the other States members, stating the reasons for its decision. Likewise it shall inform the manufacturer or responsible for the marketing of the biocidal product measures.

In any case, it will be to what is definitely decided by the competent Community bodies.

Article 26. Registry officer of biocides.

All biocides, evaluated in accordance with the procedures established in this Royal Decree, both for its approval to its registration as a low-risk biocidal products, shall be entered in the biocides of official record of the General direction of public health of the Ministry of health and consumption.

Article 27. Requirements for the manufacture, storage, marketing and implementation.

The premises or installations are manufactured and/or formulated biocidal products, as well as which stored or marketed biocidal products authorised for professional use and utilities which are thus determined by regulation, will be registered in the official register of establishments and services biocides in each autonomous community. This registry will be managed by the competent health authority.

Article 28. Book official movements of biocides biocidal products classified in the categories of toxic and very toxic will be marketed and applied under a system of control based on the record of each operation, with the corresponding reference of the production batch and the number of the official register of establishments and services biocides, in a book movements officer of biocidal products, which will be supervised by the competent authority of the autonomous region.

Article 29. Training courses.

Without prejudice to provisions of law 31/1995 of 8 November, on occupational risk prevention, biocides utilities staff must overcome courses or training tests approved by the Ministry of health and consumption, which, if necessary, will coordinate its actions with other ministries.

Article 30. Infractions.

Without prejudice to other regulations which might result from application, offences committed against the provisions of this Royal Decree shall be regarded as administrative violations of sanitary regulations, in accordance with the provisions of Chapter VI of title I, Act 14/1986 of 25 April, General health and remaining provisions that may apply.

Offences are graded as mild, severe and very severe, according to the criteria of risk to health, amount of eventual benefit earned, degree of intentionality, severity of the produced health and social disruption, widespread infringement and recidivism.

1. are considered minor offences: failure to comply with the requirements, obligations or prohibitions established in this Royal Decree or provisions that develop it, in terms that are not considered as serious or very serious failure as it stipulates that article 35-A-3rd of the General Law of health.

2 are considered grave breaches: a) the resistance to supply information to the competent authority, in relation to the data required for the evaluation process for the registration, authorisation and marketing of biocidal products, according to provisions of article 35-B-4th and 5th of the General Law of health.

(b) no provision of the data required on the tab of the biocidal product safety data, them referred to in article 20, as so-called than those provided for in article 35-B-1st and 2nd of the General Law of health.

(c) breach of the obligation of information and the requirements laid down in articles 14.1 and 16, where not appropriate qualification as very serious, considered as so-called than those provided for in article 35-B-1st and 4th of the General Law of health.

(d) the breach of the requirements on classification, packaging and labelling laid down in article 19, considered as so-called than those provided for in article 35-B-1st and 2nd of the General Law of health.

(e) the marketing of biocidal products whose authorization or registration is expired, except for interim extension of the same, as so-called than those provided for in article 35-B-1st and 4th of the General Law of health.

(f) the performance of the advertising of a biocidal product which does not conform to the provisions of article 21 of this Royal Decree and other implementing rules, considered as so-called than those provided for in article 35-B-1st and 4th of the General Law of health.

(g) the recidivism in the Committee on minor offences in the past three months, as provided for in article 35-B-7 of the General Law of health.

3 are considered very serious infringements: a) the marketing of biocidal products without prior authorisation or registration, considered as course on those provided for in article 35-C-1st and 2nd of the General Law of health.

(b) the marketing of biocidal products banned or limited to a particular use, as well as those they had commanded its withdrawal from the market, considered as so-called than those provided for in article 35-C-1st and 2nd of the General Law of health.

(c) the marketing of biocidal products for active substances not included in annex I or IA and marketing as basic substances of substances not included in Annex IB, considered as so-called than those provided for in article 35-C-1st and 2nd of the General Law of health.

(d) the manufacture, storage, marketing, or application of biocidal products, in conditions that pose serious risk to public health or which fail to comply with provisions of the records of establishments and services biocides, as it stipulates that article 35-C-1st and 2nd of the General Law of health.

(e) the distortion of the information necessary for the approval or registration, its amendments and renewals, as well as which must appear on the label and on the safety data sheet, as it stipulates that article 35-C-1st and 2nd of the General Law of health.

(f) the use of biocides in application techniques, conditions or applications other than those authorized, as well as non-compliance with the safety limits, as provided for in article 35-C-1st and 2nd of the General Law of health.

(g) composition of unauthorized changes that affect the active substances or possible risk, as well as unauthorized changes of other components of the biocidal product, considered as assumptions as provided in article 35-C-1st and 2nd of the General Law of health.

(h) the failure to comply with measures taken in application of the safeguard clause, as provided for in article 35-C-1st and 2nd of the General Law of health.

(i) in the Commission's failures relapse serious in the last five years, as it stipulates that article 35 - C - 8th of the General Law of health.

Article 31. Sanctions.

1. the acts or omissions constituent of infringement, as provided for in article 30 of this Royal Decree, will be subject to penalties as provided for in article 36 of the law 14/1986 of 25 April, General health.

2. such sanctions be imposed upon instruction of the corresponding record, in accordance with the provisions of law 30/1992, of November 26, the legal regime of public administrations and common administrative procedure, modified by the law 4/1999 of 13 January and in the development of these standards.


3. sanctions shall be independent of which may be imposed by other authorities competent State or autonomous, based on grounds other than the infraction to the sanitary regulations.

For this purpose, different authorities shall exchange history and information that is in its possession.

Sole additional provision. Records.

Environmental use pesticides and the use in the food industry, use in personal hygiene and disinfectants for surgical and clinical environments, and the livestock use attached to the records provided for in Royal Decree 3349/1983, of 30 November, and Royal Decree 443/1994 of 11 March, will continue enrolling in their respective records from the General direction of public health , and Directorate General of Pharmacy and health products from the Ministry of health and consumption, and the General direction of animal husbandry of the Ministry of agriculture, fishing and food, during the transitional period laid down in the first transitional provision of this Royal Decree. Likewise, for these products and during this transitional period, will continue to apply the order of 24 February 1993, which are standardised registration and operation of the register of establishments and services pesticides.

Once a decision has been taken at Community level in relation to the inclusion or not of the active substance in annex I, IA or IB, these biocidal products shall be directed to the biocides of official record of the General direction of public health, who shall grant, modify, or revoke, as appropriate, the authorisations or, where applicable, records of biocidal products containing those active substances, and comply with the procedures established in this Decree.

Pesticides used as guards for conservation of Wood sawn, processed or transformed registered in the official register of products and Material standing of the direction General of Agriculture of the Ministry of agriculture, fisheries and food, will be transferred within a period of six months from the publication of the present Royal Decree, to the registry of the General direction of public health.

First transitional provision. Deadlines for the review of active substances.

However the provisions of paragraph 1 of article 3, paragraph 1 of article 5; in paragraphs 3 and 5 of article 8, and without prejudice to paragraph 7 of article 17, as well as the provisions of the third paragraph of this provision, for a period of ten years commencing on 14 May 2000, may continue applying the Royal Decree 3349/1983 and subsequent amendments, to the non-agricultural pesticides (biocides) regulated in the same and which contain active substances on the market on the date indicated that a decision has been taken at Community level on the inclusion or not of the substance to active in annex I, IA or IB.

The rest of the biocidal products containing active substances on the market on the date may 14, 2000 and for which does not apply the aforementioned Royal Decree, may continue to be marketed until a decision has been taken at Community level on the inclusion or not of such active substances in annex I, IA or IB. Once it has made such decision, the biocidal products containing those active substances, and comply with the provisions of this Royal Decree, shall be entered in the biocides of official record of the General direction of public health, who shall grant the authorizations or where appropriate the records of these biocides.

During this ten year period be established a review procedure of the active substances on the market prior to the 14 May 2000 as active substances of a biocidal product for purposes other than those defined in paragraphs or) and p) of article 2.

This review shall be carried out in accordance with the regulations of the European Commission will publish periodically, which will gather the provisions necessary for the establishment and the implementation of the programme, including setting priorities for the evaluation of the different active substances and the corresponding calendar. The first of these regulations, Regulation (EC) number 1896 / 2000, the Commission, on 7 September has already been published.

Second transitional provision. Control of biocidal products for existing active substances.

In order to respond to a request of medical order and in accordance with article 22 of this Royal Decree, the manufacturers or persons responsible for marketing of the biocidal products referred to in the second paragraph of the transitional provision first, must submit to the Directorate-General of public health, on May 14, 2003 preferably in electronic format, information about the chemical composition, label and where appropriate explanatory booklet, all the 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, while the product is put on the market, the information referred to above, for all the biocidal products which are placed on the market after the entry into force of this Royal Decree.

Third transitional provision. Deadlines for updating old records.

All products entered in the appropriate registers of the General Directorate for Pharmacy and medical devices that have been transferred to the General Directorate of public health, based on Royal Decree 162/1991 and that has not been accommodated the precepts laid down in the technical regulation of pesticides, will be within six months from the entry into force of this Royal Decree for its adaptation and reclassification. Likewise, environmental use and use in the food industry, disinfectant products registered prior to the year 1991 in the General Directorate for Pharmacy and medical devices or the General Health Registry of food, will be within six months from the entry into force of this Royal Decree for his adaptation and reclassification.

Similarly, all disinfectant for environmental use and use in the food industry that are placed on the market and are not reported, will have a period of six months from the entry into force of this Royal Decree to apply for its registration. The same deadline applies for the regularization of the protectors of wood which will no longer be applicable the provisions of the second additional provision of the Royal Decree 2163 / 1994 of 4 November, whereby the community harmonised authorisation system is implanted to market and use of plant protection products.

Sole repeal provision. Repeal legislation.

They are hereby repealed many provisions of equal or lower rank to oppose provisions of this Royal Decree disposition first. Skill-related title.

This Royal Decree is issued under cover of the provisions of article 149.1.16. ª and 23.ª of the Constitution and in accordance with the provisions of article 40, paragraphs 1, 2, 5 and 6 of the Act 14/1986 of 25 April, General health.

Second final provision. Faculty of development.

It empowers the Ministers of health, agriculture, fisheries and food and environment so that, in the scope of their powers, they proceed to the development of the provisions of this Royal Decree, as well as to impart the necessary rules for the updating of the technical annexes contained in it and the coordination of the requirements for registration in the records of the autonomous communities determining the conditions of manufacture, storage, marketing and application and conditions and courses of training for staff of utilities biocides.

Third final provision. Budgetary adjustment.

The Ministry of finance will conduct accurate budget changes for compliance with the provisions in the present Royal Decree.

Fourth final provision. Entry into force.

This Royal Decree shall enter into force the day following its publication in the "official bulletin of the State".

Given in Madrid on October 11, 2002.

JUAN 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 Annex IB list of basic substances Annex IIA documentation fundamental low-risk biocidal products for active substances chemical substances 1. Dossiers on active substances should address at least all the points listed under 'Dossier requirements'. The answers should be supported by data. The dossier requirements must be abreast of technical advances.

2. information which is not necessary owing to the nature of the biocidal product or the uses to which it is intended shall not be provided. The same applies where it is not scientifically necessary or technically possible to supply the information. In these cases, a justification acceptable to the competent authority must be submitted. Such a justification may be the existence of a frame-formulation to which the applicant has a right of access.

I. applicant documentation requirements.

II. identity of the active substance.

III. physical properties and chemical active substance.

IV. methods of detection and identification.

V. effectiveness against the agencies for which it is intended and intended uses.

VI. toxicological profile for man and animals, including metabolism.


VII. profile ecotoxicological, including fate 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 sections II to IX.

The above points should be supported by the following data: I. applicant: 1.1 name, surname and address, etc.

1.2. manufacturer of the active substance (name, surname, address and location of the installation).

II. identification: 2.1 common name proposed or accepted by ISO and synonyms.

2.2. chemical name (IUPAC nomenclature).

2.3. manufacturer's development code number.

2.4 numbers CAS and EC (if known).

2.5 empirical and formulas developed (including full details of any isomeric composition) and molecular mass.

2.6. method of manufacture (abbreviated synthesis pathway) 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 formula and the possible concentration expressed in g/kg or g/l, as appropriate.

2.9. origin of the natural active substance or the precursor (s) of the active substance, e.g. an extract of a flower.

2.10. exposure data in accordance with Annex VIIA of Royal Decree 363/1995, of 10 March, which approves the regulation on the notification of new substances and the classification, packaging and labelling of dangerous substances.

III. physical properties and chemical: 3.1 melting point, boiling point, relative density (1).

3.2 steam pressure (in Pa) (1).

3.3. appearance (physical state, colour) (2).

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

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

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

3.7. thermal stability and identity of relevant breakdown products.

3.8 flammability including auto-flammability and identity of combustion products.

3.9. flash point.

3.10. surface tension.

3.11. explosive properties.

3.12 oxidising properties.

3.13. reactivity with the packaging materials.

IV. analytical methods for detection and identification: 4.1 analytical methods for the determination of pure active substance and, where appropriate, for the determination of degradation products, isomers and relevant impurities of the active substance and additives (e.g. stabilisers).

(4.2. analytical methods including recovery rates and the limits of determination for the active substance and its waste, and, where appropriate, in: to) ground.

(b) air.

(c) water: the applicant confirmed that the substance and any of their metabolites and of degradation and reaction products covered by the definition of pesticide defined in the legislation of water for human consumption and that can be estimated reliably to the parametric value specified in this regulation for each individual pesticide.

(d) fluids and body tissues of humans and animals.

V. effectiveness against organisms that is intended in the labelled uses: 5.1 function, e.g. fungicide, rodenticide, insecticide, bactericide.

5.2 organism (s) to be controlled and products, organisms or objects to be protected.

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

5.4. mode of action (including the period).

5.5. field of use envisaged.

5.6. user: Industrial, professional, public in general (non-professional).

5.7. information on the occurrence or possible occurrence of resistance and appropriate strategies for moving forward.

5.8. estimated quantities that will be available annually, expressed in tons.

VI. toxicological and metabolic studies: 6.1. Toxicity acute. - for testing 6.1.1 to 6.1.3, substances that are not gases should be administered, at least in two ways, one of them being the oral. The choice of the second route will depend on the nature of the substance and 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 eye and skin irritation (3).

6.1.5. skin sensitization.

6.2. metabolic studies in mammals. - Basic toxicokinetics, including a study of dermal absorption.

In following studies 6.3 (where applicable), 6.4, 6.5, 6.7 and 6.8, it is obligatory to use as a route of Administration oral, unless it can be justified that it is best suited to another via.

6.3 short-term doses repeated (28 days) toxicity.-this study will not be required when a sub-chronic toxicity study is available in rodent.

6.4. subchronic toxicity - 90 day study in two species, one rodent and one non-rodent.

6.5. chronic toxicity (4).-one rodent species and other species of mammal.

6.6. genotoxicity studies.

6.6.1. in vitro study of genetic mutation in bacteria.

6.6.2 in mammalian cells in vitro cytogenicity study.

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

6.6.4 if results 6.6.1, 6.6.2 or 6.6.3 are positive, it will be necessary to make a study of mutagenicity in vivo (test in bone marrow for chromosomal lesions or micronucleus test).

6.6.5 if 6.6.4 results are negative but tests in vitro positive will be a second in-vivo study to examine whether mutagenicity or evidence of DNA damage in tissue other than bone marrow can be demonstrated.

6.6.6. If 6.6.4 results are positive, it will be necessary to do a trial to assess possible germ cell effects.

6.7. carcinogenicity (4) study.-one rodent species and other species of mammal. These studies can be combined with the 6.5.

6.8. toxicity to the reproductive function (5).

6.8.1. teratogenicity test: rabbit and one rodent species.

6.8.2. fertility study: at least two generations, one species, male and female.

6.9. medical data in anonymous form.

6.9.1. data of medical surveillance of manufacturing facilities staff, if you have them.

6.9.2 direct observation, e.g. clinical cases or cases of poisoning, if you have them.

6.9.3. health, both from industry and from any other available source records.

6.9.4 epidemiological studies of the population in general, if you have them.

6.9.5. diagnosis of poisoning including specific signs of poisoning and clinical trials, if they are available.

6.9.6 observations of awareness or allergenicity, if available.

6.9.7. specific treatment in case of accident or poisoning. Measures for first aid, antidotes and medical treatment, if known.

6.9.8. prognosis of intoxication.

6.10 Summary of toxicology in mammals and conclusions, including no observed adverse effect (NOAEL) level, level without effect (NOEL), overall evaluation of all toxicological data and any other information on the active substance. Whenever possible, will be included in the summary form any measure of protection of the worker suggested.

VII. studies on the active substance ecotoxicological: 7.1. Acute toxicity to fish.

7.2. acute toxicity to "Daphnia magna".

7.3 algae growth inhibition test.

7.4. inhibition of microbial activity.

7.5. bioconcentration. Fate and behaviour in the environment.

7.6 degradation.

7.6.1 biotic.

7.6.1.1. biodegradability.

7.6.1.2. inherent biodegradability, where appropriate.

7.6.2 abiotic.

7.6.2.1. hydrolysis as a function of pH and identification of breakdown products.

7.6.2.2. phototransformation in water including identity of the products of transformation (I).

7.7 absorption/desorption screening test.-when the results of this test indicate it will be necessary to make the tests described in point 1.2 of part XII.1 of Annex IIIA or those described in Annex IIIA part XII.2 paragraph 2.2.

7.8. Summary of ecotoxicological effects and fate and behaviour in the environment.

VIII. necessary measures for the protection of humans, animals and the environment: 8.1. Precautions and recommended practices relating to the handling, use, storage, transport and fire.

8.2. in case of fire, nature of reaction products, gas combustion, etc.

8.3. in case of accident emergency measures.

((8.4. possibility of destruction or decontamination following release: a) air, b) water, including drinking water, c) soil.

8.5. procedures for waste management of the active substance for industry or professional users.

8.5.1. possibility of reuse or recycling.

8.5.2. possibility of neutralisation of effects.

8.5.3 conditions controlled discharge including leachate qualities on disposal.

8.5.4. conditions for controlled incineration.

8.6. observations of unwanted or undesirable side effects e.g. on beneficial organisms or other bodies other than the body for which it is intended.

IX. classification and labelling: proposed, including justification for the proposals for classification and labelling of the active substance pursuant to the Royal Decree 363/1995, of 10 March, which approves the regulation on the notification of new substances and the classification, packaging and labelling of dangerous substances.

Hazard symbols.

Indications of danger.


Phrases concerning risks.

Safety phrases.

X summary and evaluation of sections II to IX.

(1) must report these data with respect to the purified active substance of stated specification.

(2) must report these data with regard to the active substance of stated specification.

(3) the eye irritation test shall not be necessary when it has been shown that the active substance can have potential corrosive properties.

(4) the long-term toxicity and carcinogenicity of an active substance may not apply when proven conclusively so that such tests are not necessary.

(5) If, in exceptional circumstances, be declared that this test is not necessary, fully such declaration must be justified.

Annex IIB fundamental data common to biocidal products chemical products 1. Dossiers on biocidal products should respond, at least all the points listed under 'Dossier requirements'. The answers should be supported by data. The dossier requirements must be abreast of technical advances.

2. information which is not necessary owing to the nature of the biocidal product or the uses to which it is intended shall not be provided. The same applies where it is not scientifically necessary or technically possible to supply the information. In these cases, a justification acceptable to the competent authority must be submitted. Such a justification may be the existence of a frame-formulation to which the applicant has a right of access.

3. the information can be obtained from existing data when present a justification acceptable to the competent authority. In particular, and whenever possible, in order to minimize animal testing, should apply the provisions contained in the Royal Decree 1078 / 1993, of 2 July, which approves the regulation on classification, packaging and labelling of dangerous preparations.

I. applicant documentation requirements.

II. identity and composition of the biocidal product.

III. physical properties and chemical of the biocidal product.

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

V. intended uses of the product and efficacy in these applications.

VI. toxicology data for the biocidal product (additional to that for the active substance).

VII. ecotoxicological (additional to that for 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 sections II to IX.

The above points should be supported by the following data: I. applicant: 1.1. Name, surname and address, etc.

1.2. manufacturer of the biocidal product and the active substance [names, addresses, including location of the (s) (s)].

II. identification: 2.1. Trade name or trade name proposed, as well as code number manufacturer's development of the preparation, if necessary.

2.2 Declaration detailed on the quantitative and qualitative composition of the biocidal product, e.g., substance or active substances, impurities, co-Formulants or inert components.

2.3. physical state and nature of the biocidal product, e.g. emulsifiable, solution or wettable powder.

III. physical, chemical and technical properties: 3.1. Appearance (physical state, colour).

3.2. explosive properties.

3.3 oxidising properties.

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

3.5. acidity or alkalinity and if necessary pH (to 1 per 100 in water).

3.6. relative density.

3.7. storage stability: stability and shelf-life. Effects of light, temperature and humidity on technical characteristics of the biocidal product; reactivity compared to the container material.

3.8. technical characteristics of the biocidal product, e.g. wettability, persistent foaming, flowability, pourability and dustability.

3.9. physical-chemical compatibility with other products including other biocidal products with which go to authorize its use.

IV. methods of identification and analysis: 4.1. Analytical method for determining the concentration (s) of substance (s) active (s) in the biocidal product.

(4.2. insofar as not covered in point 4.2 of Annex IIA, analytical methods including recovery rates and the limits of components toxicologically and ecotoxicologically relevant of the biocidal product or residues thereof where appropriate in: to) ground.

(b) air.

(c) water (including drinking water).

(d) fluids and tissues, body, human and animal.

(e) food or feed treated.

V. intended uses and efficacy of these: 5.1. Product type and field of use envisaged.

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

5.3. application rate and if appropriate, final concentration of the biocidal product and active substance in the system that will be using the preparation, for example, cooling water, water used for heating water or surface.

5.4 number and rate of applications, and where relevant, any particular information relating to geographical or climatic variations or waiting periods necessary to protect human and animal.

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

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

5.7. effects on organisms for which it is intended.

5.8 mode of action, including the length of time, in so far as not covered by Annex IIA, paragraph 5.4.

5.9. user: Industrial, professional or public in general (non-professional). Efficacy data.

5.10 labelling statements proposals for the product and efficacy data to support these declarations, including any standard protocols used, laboratory tests, or, where appropriate, field trials.

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

VI. toxicological studies: 6.1. Toxicity acute. - for testing 6.1.1 to 6.1.3, biocidal products which are not gases should be administered, at least in two ways, one of them being the oral. The choice of the second route will depend on the nature of the substance and 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. for biocidal products that are intended for authorization for use with other biocidal products, the mixture of biocidal products will undergo trial, if possible, to study acute dermal toxicity and skin and eye irritation, as appropriate.

6.2. skin irritation and eye (1).

6.3. skin sensitisation.

6.4. information on dermal absorption.

6.5. toxicological data are available relating to non-active substances of toxicological concern (i.e. substances of concern).

6.6 information about the exposure of the biocidal product to man in general and to the operator. - when necessary, is required (n) the (the) test (s) described (s) in Annex IIA to the non-active substances of the preparation with toxicological significance.

VII. studies ecotoxicological: 7.1. Foreseeable routes of entry into the environment on the basis of the intended use.

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

7.3 information ecotoxicological available relating to non-active substances of importance (i.e. substances of concern), 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 recommended practices relating to the handling, use, storage, transport or fire.

8.2. specific treatment in case of accident, for example, first aid, antidotes, medical treatment, if possible; emergency measures to protect the environment; insofar as this is not covered in item 8.3 of Annex IIA.

8.3. procedures, if any, for cleaning application equipment.

8.4 identification of relevant combustion products in case of fire.

8.5. procedures for management of residues of the biocidal product and its packaging for industrial and professional users and the public in general (non-professional users), e.g. possibility of reuse or recycling, neutralisation, conditions for controlled discharge, and incineration.

(8.6. possibility of destruction or decontamination in the event of a release to the: to) air.

(b) water, including drinking water.

(c) soil.

8.7. observations of unwanted or undesirable side effects, e.g. on beneficial organisms or other non-target organisms.

8.8 shall specify any type of repellent substance or poison control measures included in the preparation with a view to prevent action against non-organisms of the organism for which it is intended.

IX. classification, packaging and labelling: packaging and labelling proposals.

Proposals for safety data sheets, if necessary.

Proposals including justification for the classification and labelling in accordance with the principles of article 19 of the present Royal Decree: danger symbol (s); indications of danger; phrases to risks; safety phrases; instructions for use; packaging (type, materials, size, etc.), compatibility of the preparation with proposed packaging materials to be included is.

X summary and evaluation of sections II to IX.


(1) eye irritation test shall not be necessary when it has been shown that the active substance can have potential corrosive properties.

Annex IIIA additional documentation for active substances chemical substances 1. Dossiers on active substances must answer at least all the points listed under 'Dossier requirements'. The answers should be supported by data. The dossier requirements must be abreast of technical advances.

2. information which is not necessary owing to the nature of the biocidal product or the uses to which it is intended shall not be provided. The same applies where it is not scientifically necessary or technically possible to supply the information. In such cases, a justification acceptable to the competent authority must be submitted. Such a justification may be the existence of a frame-formulation to which the applicant has a right of access.

III. physical properties and chemical: 1. solubility in organic solvents, including effect of temperature on solubility (1).

2. stability in organic solvents used in biocidal products and identity of relevant breakdown (2) products.

IV. analytical methods for detection and identification: 1. analytical methods including recovery rates and the limits of determination for the active substance and the corresponding residues in food or feedingstuffs and, where appropriate, other products.

VI. toxicological and metabolic studies: 1. study of neurotoxicity. - If the active substance is an organophosphorus compound or if there are other indications that the active substance may have neurotoxic properties, neurotoxic studies are required. The species used in the trial will be adult hen, unless it is justified to that other kind of test is most appropriate. In your case, delayed neurotoxicity tests will be required. If anticholinerterase activity is detected, it shall be deemed the possibility of a trial of anticholine agents response.

2. toxic effects on livestock and pets.

3. studies related to human exposure to the active substance.

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

5. If it is considered necessary to carry out any other tests related to the exposure of human beings to the active substance in the biocidal products that are proposed, will be required the tests referred to in point 2 of paragraph XI.

6. If the active substance is to be used in products for action against plants, it will be necessary to carry out tests to assess toxic effects of metabolites from treated plants, if any, when they are different from those found in animals.

7. study of the mechanisms of action. - any studies necessary to clarify effects reported in toxicity studies.

VII. studies ecotoxicological: 1. acute toxicity test on one other, non-aquatic, non-organism for which it is intended.

2. If the results of the ecotoxicological studies and the intended use of the active substance indicate a danger for the environment, it will be necessary to carry out the tests described in sections XII and XIII.

3. If the results of the tests in point 7.6.1.2 of Annex IIA is negative and if the likely elimination of the active substance and of its preparations via is the treatment of sewage, will be necessary to carry out the tests described in point 4.1 paragraph XIII.

4. any other trial biodegradability tests that are relevant from the results in paragraphs 7.6.1.1 and 7.6.1.2 of Annex IIA.

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

6. If the results of the tests provided for mention in 7.6.1.2 in Annex IIA or in paragraph 4, above indicate the need to do so, or the active substance has an overall low or absent abiotic degradation, will be necessary to carry out the tests described in paragraphs 1.1, part 2.1 and, where appropriate, point 3 of paragraph XII.

VIII. measures to be taken for the protection of humans, animals and the environment: 1. identification of the substances that are on the list I or list II of the annex to Directive 80/68/EEC on the protection of groundwater against pollution caused by certain dangerous substances transposed to our legal system through : Law 29/1985, 2 of August, waters (item 94); Regulation of public water domain (articles 256 to 258) and Royal Decree 1315 / 1992 of 30 October, whereby partially amending the regulation of the hydraulic public domain, that develops the titles preliminary, I, IV, V, VI, and VII of the law 29/1985, 2 of August, waters, approved by Royal Decree 849/1986, of 11 April.

XI. further human health-related studies: 1. studies on food and feed: 1.1 identification of the products of decomposition and reaction and of metabolites of the active substance in treated or contaminated feed or food.

1.2. behaviour of the residue of the active substance, its degradation products and, where appropriate, their metabolites in the food or feed treated or contaminated, including the elimination kinetics.

1.3 global balance of matter of the active substance.

Data from the trials monitored on waste, showing enough to waste presumably resulting from the proposed use will not be cause for concern for human or animal health.

1.4. estimation of potential or actual exposure of humans to the substance activates by diet or other means.

1.5. If residues of the active substance remain on feedingstuffs for a significant time period, studies of nutrition and metabolism in cattle that allow the evaluation of residues in food of animal origin will be required.

1.6. effects of industrial processing or domestic preparation on the nature and magnitude of residues of the active substance.

1.7. proposed acceptable residues and the justification of their acceptability.

1.8. any other information deemed relevant.

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

2. other tests related to the exposure of the human being. - shall be charged appropriate tests, as well as a justified case.

XII. further studies on fate and behaviour in the environment: 1. fate and behaviour in soil: 1.1 speed and pathways of decomposition, including identification of the processes involved and identification of any metabolites or breakdown products in at least three types of soil in appropriate conditions.

1.2. absorption and desorption in at least three soil types and, where relevant, absorption and desorption of metabolites and breakdown products.

1.3. mobility in at least three soil types and where relevant mobility of metabolites and breakdown products.

1.4 magnitude and nature of fixed residue.

2. fate and behaviour in water: 2.1 speed and process of decomposition in aquatic systems (as is not referred to in point 7.6 of Annex IIA), including identification of metabolites and breakdown products.

2.2. absorption and desorption in water (sedimentary systems) and, where relevant, absorption and desorption of metabolites and breakdown products.

3. fate and behaviour in the air. - If the active substance is to be used in preparations for fumigation, is going to be applied by spraying, is volatile, or if any other information indicates that it is relevant, the speed will be determined and decomposition in the air via insofar as those referred to in point 5 of paragraph VII.

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

XIII. studies additional ecotoxicological: 1. effects on birds: 1.1 acute oral toxicity: not necessary if you have selected a species of birds in the study of point 1 of paragraph VII.

1.2. short-term toxicity: study of eight days on the diet, at least one species (other than chickens).

1.3. effects on reproduction.

2. effects on aquatic organisms: 2.1 toxicity in an appropriate species of fish.

2.2. effects on reproduction and growth rate of an appropriate species of fish.

2.3. bioaccumulation in an appropriate species of fish.

2.4 reproduction and growth rate of "Daphnia magna".

3. effects on other non-target organisms of the organism for which it is intended: 3.1 acute toxicity to honeybees and other beneficial arthropods, e.g. predators. Will be selected a body of trial other than that used in paragraph 1 of section VII.

3.2. toxicity to earthworms and other soil macro-other than the Agency for which it is intended.

3.3. effects on soil micro-organisms other than the Agency for which it is intended.

3.4. effects on any other body specific, other than the Organization to which it is intended (flora and fauna), are considered at risk.

4. other effects: 4.1 activated sludge respiration inhibition test.

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

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

(2) these data must be provided for the active substance whose specification is indicated.

Annex IIIB additional documentation for biocidal products chemical products


1. dossiers on biocidal products should answer at least all the points listed under 'Dossier requirements'. The answers should be supported by data. The dossier requirements must be abreast of technical advances.

2. do not be provided information which is not necessary owing to the nature of the biocidal product or of its proposed uses. The same applies where it is not scientifically necessary or technically possible to supply information. In such cases, an acceptable communication must present to the competent authority.

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

3. the information can be obtained from existing data when present a justification acceptable to the competent authority. In particular, and whenever possible, in order to minimize animal testing should be applied the provisions contained in the Royal Decree 1078 / 1993, of 2 July, which approves the regulation on classification, packaging and labelling of preparations hazardous.

XI. further human health-related studies: 1. studies on food and feed: 1.1 if residues of the biocidal product remain on feedingstuffs for a significant time period, it will require studies of nutrition and metabolism in cattle that allow the evaluation of residues in food of animal origin.

1.2. effects of industrial processing and/or domestic preparation on the nature and magnitude of residues of the biocidal product.

2. other tests related to the exposure of the human being. - shall be charged appropriate tests, as well as a case reasoned for the biocidal product.

XII. further studies on fate and behaviour in the environment: 1. where appropriate, the information required in section XII of Annex IIIA.

2 distribution and dissipation tests: to) ground.

(b) water.

(c) air.

The trial of the previous points 1 and 2 requirements are only applicable to the corresponding elements of ecotoxicological.

XIII. studies additional ecotoxicological: 1. effects on birds: 1.1 acute oral toxicity, if not already done in accordance with the provisions of point 7 of Annex IIB.

2. effects on aquatic organisms: 2.1 in the case of application above, within or close to surface waters.

2.1.1. particular studies with fish and other aquatic organisms.

2.1.2 residue data in fish concerning the active substance and including toxicologically relevant metabolites.

2.1.3 may require studies that referred to in points 2.1, 2.2, 2.3 and 2.4 of section XIII of Annex IIIA to the relevant components of the biocidal product.

2.2. If the biocidal product must be sprayed near to surface waters, a study of the spray mist may be required to assess risks to aquatic field agencies.

3. effects on other non-target organisms from the agencies for which it is intended: 3.1 toxicity to vertebrate land other than birds.

3.2. acute toxicity for bees.

3.3. effects on beneficial arthropods other than bees.

3.4. effects on earthworms and other soil macro-different from the agencies for which it is intended to be at risk.

3.5. effects on soil micro-organisms other than the Agency for which it is intended.

3.6. effects on any other specific bodies other than the body for 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. supervised trials of risk assessment for non-organisms of the agencies for which it is intended under field conditions.

3.7.2. studies on acceptance of the biocidal product by ingestion in any organisms organisms that goes considered at risk.

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

Annex IVA documentation for active substances FUNGI, micro-organisms and viruses 1. Dossiers on active organisms must answer at least all the points listed under 'Dossier requirements'.

The answers should be supported by data. The dossier requirements must be abreast of technical advances.

2. do not be provided information which is not necessary owing to the nature of the biocidal product or of its proposed uses. The same applies where it is not scientifically necessary or technically possible to supply information. In such cases, an acceptable communication must present to the competent authority.

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

Requirements for documentation i. data of the applicant.

II. identity of the active organism.

III. source of active organism.

IV. methods of detection and identification.

V. biological properties of active organism, including pathogenicity and infectivity for agencies target and for which it are not included the human being.

VI. effectiveness and intended uses.

VII. toxicological profile for man and animals, including metabolism of toxins.

VIII. profile ecotoxicological, including fate and behaviour in the environment of the organisms and of toxins that produce.

IX. measures necessary for the protection of the human being, the organisms of the organism for which it is intended and the environment.

X classification and labelling.

XI. Summary and evaluation of sections II to X.

The above points should be supported by the following data: I. applicant: 1.1 applicant (name, surname, address, etc.).

1.2 manufacturer (name, surname, address, plant location).

II. identification of the organism: 2.1 common name of organism (including alternative and superseded names).

2.2. taxonomic name and strain indicating whether it is a stock Variant or a mutant strain; in the case of viruses, naming taxonomic of the agent, serotype, strain or mutant.

2.3 reference number of the crop and in the collection where the culture is deposited.

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

III. source of the organism: 3.1 presence in nature or otherwise.

3.2 methods of isolation of the organism or active strain.

3.3. methods of cultivation.

3.4. method of production with details of containment and procedure to maintain quality and ensure a uniform source of active organism. In the case of mutant strains, must be given detailed data production and isolation, as well as any differences between the mutant strains and wild and parental strains known.

3.5 composition of the final active organism material i.e. nature, purity, identity, properties, content of any impurities or foreign body.

3.6. methods to prevent contamination and loss of virulence of the cultivation pattern.

3.7. procedures for waste management.

IV. methods of detection and identification: 4.1 methods of determining the presence and identity of the organism.

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

4.3 methods used to show microbiological purity of the final product and the control of pollutants in an acceptable level, results obtained and information on variability.

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

4.5. methods to determine viable or non-viable (e.g. toxins) residues in products treated, food, feed, fluids and tissues human body or animals, soil, water and air, as appropriate.

V. biological properties of the organism: 5.1 history of the organism and its use, including even where is known its general natural history and, where appropriate, their geographical distribution.

5.2. relations with pathogens of vertebrates, invertebrates, plants or other organisms.

5.3. effects on the organism for which it is intended.

Pathogenicity or kind of antagonism to the host. There will be details of the range of specificity for the host.

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

5.5. possible effects on non-target organisms to the body that is intended to closely related to it, including infectivity, pathogenicity and transmissibility.

5.6. transmissibility to other agencies is intended to that.

5.7. any other biological effects on non-target organisms to the agency that is intended, when used properly.

5.8. infectivity and physical stability when used properly.

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

5.10. any pathogenicity and infectivity to man and animals under conditions of immunosuppression.

5.11. pathogenicity and infectivity for known parasites / predators of the species for which it is intended.

VI. effectiveness and intended uses: 6.1 harmful organisms controlled and materials, substances, organisms or products that must be treated or protected.


6.2. intended uses, for example, insecticide, disinfectant, anti-fouling product, etc.

6.3 information or observations on unwanted or undesirable side effects.

6.4. information on the occurrence or possible occurrence of the development of resistance and possible strategies for moving forward.

6.5. effects on organisms for which it is intended.

6.6. category of user.

VII. toxicological and metabolic studies: 7.1 toxicity acute. - in cases where a single dose is not appropriate will be a series of evaluation tests to detect highly toxic agents and infectivity.

(1) oral;

(2) dermal;

(3) by inhalation;

(4) skin irritation and, if necessary, eye;

(5) skin sensitisation and, where necessary, respiratory sensitisation and, 6) for viruses and viroids, cell culture studies using purified infective virus and primary cell cultures of mammalian, avian and fish cells.

7.2. subchronic toxicity - study of ninety days, two species, one rodent and one non-rodent.

1) oral administration;

(2) other routes (inhalation, dermal) as appropriate; and, 3) for viruses and viroids test for infectivity carried out by bio assay or on a cell culture suitable, 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 another route more appropriate.

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

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

7.6 the reproductive toxicity: teratogenicity test: rabbit and one rodent species.

Study of fertility: A species, at least two generations, male and female.

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

7.8. neurotoxicity studies required when any indication of activity there anticholinerterase or other neurotoxic effects. Where appropriate, trials delayed neurotoxicity using adult hens will be made.

7.9. immunotoxicity, e.g. allergenicity studies.

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

(7.11 human exposure data, including: 1) medical data in anonymous form (if available);

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

(3) epidemiological data (if available);

(4) data of poisoning incidents;

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

(6) treatment for poisoning and prognosis.

7.12. Summary of mammalian Toxicology: conclusions (including NOAEL, NOEL and if appropriate, IDA), overall evaluation of all the data, toxicological, pathogenicity and infectivity and any other information concerning the active organism. It will include a summary of suggestions for user protection measures, wherever possible.

VIII. studies ecotoxicological: 8.1 acute toxicity in fish.

8.2. acute toxicity to "Daphnia magna".

8.3. effects on the growth of algae (inhibition test).

8.4. acute toxicity on one other, non-aquatic, non-organism for which it is intended.

8.5. pathogenicity and infectivity for honeybees and earthworms.

8.6. acute toxicity or pathogenicity and infectivity for other non-target organisms to the body to which it is intended to be at risk.

8.7. effects, if any, in other species of fauna and flora.

8.8 where toxins are produced, data as outlined in section 7.1 to 7.5 points will be given VII of Annex IIA.

Fate and behaviour in the environment.

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

8.10 where toxins are produced, data as outlined in paragraph 7.6 to 7.8 points will be given VII of Annex IIA.

IX. necessary measures for the protection of the human being, the organisms of the organism for which it is intended and the environment: 9.1 methods and precautions to be taken for storage, handling, transport and use, or in the event of a fire or other accident likely.

9.2. any circumstances or situation of the environment in which should not use the active organism.

9.3 can transform the organism non-infective and any method to do so.

9.4. consequences of the contamination of air, soil and water, particularly drinking water.

9.5 in the event of accident emergency measures.

9.6 procedures for waste management of the active organism, including the characteristics of the leachate in the disposal area.

9.7. possibility of destruction or decontamination following the release in air, water, soil or others, as appropriate.

X classification and labelling: proposals for classification in one of the risk groups proposed in article 3 of the Royal Decree 664/1997, of May 12, on the protection of workers from the risks related to exposure to biological agents at work, with justification of the proposal, together with indications of the need that products have the sign of biological hazard that appears in annex III of the aforementioned Royal Decree on the protection of workers from risks related to exposure to biological agents at work.

XI. Summary and evaluation of sections II to X.

Annex IVB documentation for biocidal products FUNGI, micro-organisms and viruses 1. Dossiers on biocidal products should answer at least all the points listed in the table below, "Documentation requirements". Responses must rely on data. The dossier requirements must be abreast of technical advances.

2. do not be provided information which is not necessary owing to the nature of the biocidal product or of its proposed uses. The same applies where it is not scientifically necessary or technically possible to supply information. In such cases, an acceptable communication must present to the competent authority.

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

3. the information can be obtained from existing data when present a justification acceptable to the competent authority. In particular, and whenever possible, in order to minimize animal testing, should apply the provisions of the Royal Decree 1078 / 1993, of 2 July, which approves the regulation on classification, packaging and labelling of preparations hazardous.

I. applicant documentation requirements.

II. identity and composition of the biocidal product.

III. technical of the biocidal product properties and any complementary for the active organism biocide properties.

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

V. intended uses of the product and efficacy in these applications.

VI. toxicology data for the biocidal product (additional to that for the active organism).

VII. ecotoxicological (additional to that for 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.

The above points should be supported by the following data: I. applicant: 1.1 name, surname, address, etc.

1.2 manufacturer of the biocidal product and the active organism, including plant location.

II. identification of the biocidal product: 2.1 trade name or proposed trade name, as well as of the biocidal product manufacturer's development code number, where appropriate.

2.2 Declaration detailed quantitative and qualitative composition of the biocidal product, e.g. active organisms, inert components, extraneous organisms, etc.

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

2.4. concentration of active organism in material used.

III. technical and biological properties: 3.1 appearance (colour and odour).

3.2. storage-stability and validity. Effects of temperature, method of packaging and storage, etc., on the maintenance of biological activity.

3.3. methods for the determination of the stability of storage and their term of validity.

3.4. technical characteristics of the biocidal product: 3.4.1 wettability.

3.4.2. persistent foaming formation.

3.4.3. Suspensibility and suspension stability.

3.4.4. dry sieve test and wet sieve test.

3.4.5. particle size distribution, content of dust / fines, attrition and friability.

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

3.4.7. content of active substance in the particles of bait, granules or treated material.

3.4.8. Emulsifiability, re-emulsifiability, emulsion stability.

3.4.9. flowability, pourability and dustability.

3.5. physico-chemical compatibility with other products including other biocidal products with which go to authorize its use.

3.6 power wetting, adherence and distribution following application.

3.7. any change in the biological properties of the organism as a result of the formulation and, in particular, changes in pathogenicity or infectivity.

IV. methods of identification and analysis:


4.1. analytical method for determining the composition of the biocidal product.

4.2. methods for determining residues (e.g. biotest).

4.3 methods used to show microbiological purity of the biocidal product.

4.4 methods used to demonstrate that the biocidal product is free of any pathogen for humans or mammals or, if necessary, from pathogens harmful to non organisms organisms objective and the environment.

4.5. techniques used to ensure a uniform product and assay methods for its standardization.

V. intended uses and efficacy in these applications: 5.1 use. - type of product (for example, guard for the wood, insecticide, etc.) 5.2 details of intended use, e.g. types of harmful organism controlled, materials which will be dealt with, etc.

5.3. application rate.

5.4. when it is necessary, in the light of the test results, any specific circumstances or environmental conditions in which the product can or cannot be used.

5.5. method of application.

5.6 number and rate of application.

5.7. proposed instructions for use. Efficacy data.

5.8. oriented preliminary tests to determine the concentration.

5.9. experimentation in the field.

5.10. information on the possible development of resistance.

5.11. effects on the quality of the materials or products treated.

VI. toxicity information additional to that required for the active organism: 6.1 single oral dose.

6.2. percutaneous single dose.

6.3 inhalation.

6.4 skin irritation and, when appropriate, ocular.

6.5. skin sensitisation.

6.6. available toxicological data relating to non-active substances.

6.7 the applicator exposure.

6.7.1. Percutaneous absorption / inhalation depending on formulation and method of application.

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

VII. ecotoxicity information additional to that required for the active organism: 7.1 observations on unwanted or undesirable side effects, e.g. on beneficial organisms or other organisms from the agencies for which it is intended or persistence in the environment.

VIII. measures to be taken for the protection of the human being, the organisms of the organism for which it is intended and the environment: 8.1 recommended methods and precautions concerning handling, storage, transport and use.

8.2 terms of security, necessary period of suppression or other precautions for the protection of human beings or animals.

8.3. in case of accident emergency measures.

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

IX. classification, packaging and labelling: 9.1 proposals including justification for the classification, packaging and labelling.

(1 on the non-biological components of the product pursuant to the Royal Decree 1078 / 1993, of 2 July, which approves the regulation on classification, packaging and labelling of preparations hazardous: to) hazard symbol.

(b) indications of danger.

(c) phrases concerning risks.

(d) security-related phrases.

2nd on the labelling of the bodies active with the appropriate risk group, as set out in article 3 of the Royal Decree 664/1997, 12 of may, on the protection of workers from the risks related to exposure to biological agents at work, together with the sign of biological hazard contained in Royal Decree If necessary.

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

9.3 proposed container samples.

X summary of II - IX.

Annex V type and description of biocidal products referred to in the letter a) of article 2 of the present Royal Decree are excluded from these types of products the regulated by their specific regulations referred to in paragraph 2 of article 1 of the present Royal Decree.

Main group 1: disinfectants and General biocidal products: these product types exclude cleaning not pursuing a biocide effect, including liquid detergents and powdered and similar products.

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

Product 2.-disinfectants used in the fields of public health and private life and other biocidal products: products used for the disinfection of air, surfaces, materials, equipment and furniture which are not used in direct contact with food or feed in the sphere of private, public and industrial areas, including hospitals, as well as products used as algaecides.

Areas of use include, among others, pools, aquariums, bathing waters and others; air conditioning systems; walls and floors of hospitals and other institutions; chemical toilets, waste water, waste from hospitals, soil or other substrates (in the areas of games).

Product 3.-veterinary hygiene biocidal products: the products in this group are biocidal products used for veterinary hygiene purposes, including products used in areas in which are housed, kept or transported animals.

Type of product 4.-disinfectants for surfaces that are in contact with food and feed: products used in the disinfection of equipment, containers, consumption utensils, surfaces or pipe associated with the production, transport, storage or consumption of food, feed or drink (including drinking water) for humans or animals.

Type of product 5.-disinfectants for drinking water: products used for the disinfection of drinking water (both for humans and animals).

Main group 2: preservatives: product 6.-preservatives: products for the preservation of processed products that are not food or feedingstuffs, in containers, by controlling the microbial deterioration in order to prolong their useful life.

Product 7.-preservatives for films: products used for the preservation of films or coatings by the control of the microbial deterioration in order to protect the initial properties of the surface of materials or objects as paints, plastics, sealants, adhesive wall, covers, papers, artworks.

Type of product 8.-protectors for Woods: products used for the preservation of wood, from the stage of the sawmill inclusive, or products derived from wood, through the control of organisms that destroy or alter the wood.

They are included in this type of products both of a preventive nature as a healing.

Product 9.-protectors of fibers, leather, rubber and polymerised materials: products used for the preservation of fibrous or polymerised materials, such as leather, rubber, paper or textile products and rubber by the control of microbial deterioration.

Type of product 10.-protectors of masonry: products used for conservation and repairing treatment of materials of masonry or other construction materials other than wood by the control of microbial deterioration and the affectation due to algae.

Product 11.-preservatives for liquid cooling systems and industrial processes: products used for the preservation of water or other liquids used in systems of refrigeration and industrial processing through the control of organisms that are harmful, such as microbes, algae and mollusks.

Not included in this type of product used for the conservation of drinking water.

Product 12.-products mould: products used for the prevention or control of the proliferation of molds on materials, equipment and structures used in industrial processes, e.g. on wood and paper pulp, layers of porous sand in oil extraction.

Product 13.-metalworking-fluid preservatives: products used for the preservation of the metalworking-fluid by the control of microbial deterioration.

Main group 3: pesticides: product 14.-rodenticides: products used for the control of mice, rats or other rodents.

Product 15.-Avicides: products used for the control of birds.

Product 16.-Molluscicides: products used for the control of molluscs.

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

Product 18.-insecticides, acaricides and products to control other arthropods: products used for the control of arthropods (insects, Arachnids, crustaceans, etc.).

Product 19.-repellents and Attractants: products used to control harmful organisms (invertebrates such as fleas; vertebrates such as birds) by repulsion or attraction, including the employees, directly or indirectly, to human or veterinary hygiene.

Main group 4: other biocidal products: product 20.-preservatives for food or feedingstuffs: products used for the preservation of food or feed by the control of harmful organisms.

Product 21.-anti-fouling products: products used for the control of fixation and growth of encrusting organisms (microbes or higher forms of plant or animal species) on vessels, aquaculture equipment or other aquatic structures.


Product 22.-embalming and taxidermist fluids: products used for the disinfection and preservation of human or animal carcasses or part thereof.

Product 23.-Control of other vertebrates: products used for the control of parasites.

Annex VI common principles for the evaluation of the risk of biocidal products contained definitions: introduction.

Evaluation.

General principles.

Effects in humans.

Effects in animals.

Effects on the environment.

Unacceptable effects.

Efficiency.

Overview.

Decision-making: General principles.

Effects in humans.

Effects in animals.

Effects on the environment.

Unacceptable effects.

Efficiency.

Overview.

Overall integration of conclusions.

Definitions to) hazard identification: identification of undesirable effects which a biocidal product is inherently capable of provoking.

(b) assessment dose (concentration) response (effect): estimation of the relationship between the dose, or level of exposure, of an active substance or a substance of concern in the biocidal product and the incidence and severity of the effect.

(c) exposure assessment: calculation of concentrations / doses to which are or may be exposed human populations, animals or compartments of the environment, result of the determination of the emissions, pathways and rates of movement of an active substance or substance of concern in a biocidal product and its transformation or degradation.

(d) risk characterisation: estimation of the incidence and severity of the likely adverse effects in a human population, animals or environmental compartments, due to actual or predicted exposure to any active substance or substance of concern in a biocidal product; This may include 'risk estimation' i.e. the quantification of that likelihood.

e) environment: water, including sediment, air, land, species of fauna and wild flora all the interrelations between them, as well as the relationships between all them and any living organism.

Introduction 1. This annex lays down the principles to ensure that evaluations made and decisions taken by a Member State about the authorisation of a biocidal product that is a prepared chemical lead to a harmonised high level of protection for humans, animals or the environment, pursuant to paragraph b) of paragraph 1 of article 5 of the present Royal Decree.

2. with the aim of ensuring a harmonized high degree of protection of human health and animal and the environment, any risks arising from the use of the biocidal product must be set. This should be an evaluation of the risk in order to determine the acceptability or not of all risk, detected in the intended normal use of the biocidal product. This will be done through assessment of the risks associated with each of the relevant components of the biocidal product.

3. always must be performed a risk assessment of the substance or active substances present in the biocidal product. This will already be done for the purposes of annexes I, IA or IB. This risk assessment should involve the identification of hazards and, where appropriate, the assessment dose (concentration) - response (effect), exposure assessment and risk characterisation. When a quantitative assessment of the risk can not be made, will be made a qualitative assessment.

4. it will also risk assessments, in the same way described above, of any other substance of concern present in the biocidal product where relevant according to the use of the biocidal product.

5. to carry out the risk assessment should be a series of data specified in annexes II, III and IV. Such data are flexible depending on the type of product and the associated risks, taking account of the wide range of product types. The minimum information required will be required to carry out an adequate risk assessment. Member States shall duly take into account the requirements of articles 12 and 13 of the present Royal Decree, in order to avoid duplication in the data presentation.

However, the minimum set of data required for any type of biocidal active substance shall be those established in Annex VIIA of Royal Decree 363/1995, of 10 March, which approves the regulation on notification of new substances and the classification, packaging and labelling of dangerous substances; These data will be presented and already evaluated as part of the required risk assessment so that the active substance listed in annex I, IA or IB of this Royal Decree. Data on substances of concern present in a biocidal product may also require.

6. the results of the risk assessments carried out on an active substance and on a substance of concern present in the biocidal product will be integrated to produce an overall assessment for the biocidal product as such.

7 to make assessments and decisions on the authorisation of a biocidal product the Member State shall: a) taken into account other relevant scientific or technical information available with respect to the properties of the biocidal product, its components, metabolites, or residues.

(b) evaluate, where relevant, justifications submitted by the applicant for the non-submission of certain data.

8. the competent authority must comply with the requirements of mutual recognition set out in paragraphs 1, 2 and 5 of article 4 of the present Royal Decree.

9. it is known that many biocidal products present very slight differences in terms of its composition, and this must be taken into account when examining the records.

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

10 is known to be considered that certain biocidal products only pose a risk low; These biocides, still observing the requirements of this annex, are subject to a simplified procedure, as specified in article 3 of the present Royal Decree.

11. the application of these common principles will allow the competent authority to decide on the authorisation of a biocidal product, authorization that may be subject to restrictions on use or other conditions. In certain cases, the competent authority may request supplementary information before adopting the decision on the authorisation.

12. during the process of evaluation and adoption of the decision, the States members and applicants will collaborate in order to quickly resolve any issue requested around required data, determine promptly the need for complementary studies, change any of the conditions proposed 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), should be kept to the minimum necessary without prejudicing the level of protection required for human beings, animals and the environment.

13. the opinions of the competent authority during the process of evaluation and decision-making must be based on scientific principles, preferably recognised at international level, and have expert advice.

Evaluation principles: 14. The competent authority will check if the data submitted them to endorse the application for authorisation of a biocidal product are complete and overall scientific quality. Upon acceptance of these data, the competent authority will use them to perform a risk assessment based on the proposed use of the biocidal product.

15. always should carry out a risk assessment of the active substance in the biocidal product. If in addition there substances of concern in the biocidal product, a risk evaluation must be performed for each one of them. This assessment shall cover the intended normal use of the biocidal product, in addition to the realistic worst case, including all relevant aspects of production and disposal, both for the biocidal product itself and any material treated with it.

16. for each active substance and each substance of concern present in the biocidal product, the risk assessment shall entail an identification of hazards and, if possible, the establishment of appropriate no-observed adverse effect (NOAEL) levels. Will also include, where appropriate, an assessment of the relationship dose (concentration) response (effect), an exposure assessment and risk characterisation.

17 they must integrate the results arrived at from a comparison of the exposure to the level of concentration of no-effect for each of the active substances and substances of concern to produce an overall 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: to) the risk to humans and animals.

(b) the risk to the environment.

(c) the measures necessary for the protection of humans, animals and the environment during normal use of the biocidal product and in the worst case.

19. in certain cases it may be decided that we need to have more data to be able to complete a risk assessment. Any additional data requested shall be the minimum necessary to complete the assessment of the risk.

Effects in humans: 20. The risk assessment shall take into account the following potential effects arising from the use of the biocidal product and the population who may be exposed.


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

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

23. the identification of risk will study the properties and potential adverse effects of the active substance and any substance of concern present in the biocidal product. If, as a result of the evaluation, the biocidal product is classified in accordance with the requirements of article 19 of the present Royal Decree, will require an assessment of the relationship dose (concentration) response (effect), an exposure assessment and the risk characterisation.

24. in cases in which made the evidence of identification of the dangers in relation to a particular potential effect of an active substance or substance of concern present in a biocidal product, unless the results have led to classification of the biocidal product, it is not necessary to perform the characterisation of the risk in relation to this effect unless other reasonable grounds for concern are made for example, adverse effects on the environment or unacceptable residues.

25. the competent authority shall apply paragraphs 26 to 29 when performing an assessment of the relationship dose (concentration) response (effect) of an active substance or substance of concern present in a biocidal product.

26. will evaluate the relationship between dose and response for each active substance or substance of concern, concerning repeated-dose toxicity and reproductive toxicity, and, when possible, the NOAEL (no observed adverse effect level).

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

27. in regards to acute toxicity, corrosivity and irritation, it is generally not possible to establish a NOAEL or LOAEL on the basis of the results of the tests carried out in accordance with the requirements of the Royal Decree. For acute toxicity will be calculated values LD50 (median lethal dose) or LC50 (median lethal concentration) or, when the fixed-dose, the discriminating dose procedure has been used. As for other effects, it will be sufficient to determine whether the active substance or substance of concern has an inherent capacity to cause such effects during use of the product.

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

29. with respect to sensitization and respiratory, to there is no consensus on the possibility of identifying a dose concentration below which it is unlikely to have adverse effects in a subject already sensitised to a given substance, it is sufficient to evaluate whether the active substance or substance of concern has an inherent capacity to cause such effects during use of the biocidal product.

30. when there are data on toxicity resulting from observations of human exposure, as data from manufacturing, poisonings or epidemiology studies centres, special attention to these data will be given to carrying out the risk assessment.

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

32. the exposure assessment shall be based on the information in the technical dossier provided in conformity with article 8 of the present Royal Decree and on any other available and relevant information.

Shall be taken into account, in particular, as appropriate: the exposure data in the proper; the way in which it is marketed the product; the type of biocidal product; the method and the rate of application; the physico-chemical properties of the product; the likely routes of exposure and potential for absorption; the frequency and duration of exposure; the type and size of specific-risk populations where such information is available.

33. in the assessment of the exposure it should pay special attention to the representative exposure data, measured properly, available. If calculation methods are applied to establish exposure levels, adequate models must be used.

These models shall: a) calculate in the best possible way all relevant processes taking into account realistic assumptions and parameters.

(b) subjected to an analysis taking into account possible elements of uncertainty.

(c) be checked reliably with measurements carried out under circumstances relevant to the application of the model.

(d) comply with the conditions of the field of application.

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

34. where, for any of the purposes mentioned in paragraph 21 is determined a NOAEL or LOAEL had been identified, the risk characterisation shall entail comparison of the NOAEL or LOAEL with the evaluation of the dose/concentration to which the population will be exposed. If the NOAEL or LOAEL cannot be established, a qualitative comparison shall be made.

Effects in animals: 35. Following the same relevant principles described in the section dealing with effects on humans, the competent authority will consider the risk that the biocidal product for animals.

Effects on the environment: 36. The risk assessment shall take into account any adverse effect 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 the substances of concern present in a biocidal product. If the results obtained lead to classify the biocidal product in accordance with the requirements of this Royal Decree, will be necessary to carry out the evaluation of the relationship dose (concentration) response (effect), exposure assessment and risk characterisation.

38. in those cases in which made trials suitable for the identification of hazards related to a particular potential effect of a substance active or substance of concern present in a biocidal product, but without having given rise to a classification of the biocidal product, it's not necessary to make the characterization of the risk related to this effect, unless there are other reasonable grounds for alarm. These reasons may derive from the properties and effects of any active substance or substance of concern present in a biocidal product, in particular: the elements that indicate a potential for bioaccumulation; the characteristics of persistence; the shape of the toxicity/time curve in ecotoxicity testing; indications of other adverse effects based on the of toxicity studies, e.g. classification as a genotoxic; data on substances of similar structure; endocrine effects.

39. will be an assessment of the relationship dose (concentration) response (effect) to predict the concentration of the substance below which are not expected adverse effects in the environmental compartment concerned. The evaluation will be done for each active substance and substance of concern present in a biocidal product. This concentration is known as the predicted no-effect (PNEC) concentration.

However, in some cases, it may not be possible to establish a PNEC and there will be that make a qualitative estimation of the relationship dose (concentration)-response (effect).

40. the PNEC shall be determined based on the data on effects on organisms and ecotoxicity studies submitted as article 7 of the Royal Decree. The PNEC shall be calculated by applying an assessment factor to the resulting values of the trials with organisms, for example, DL5O (median lethal dose), LC50 (median lethal concentration), EC50 (median effective concentration), IC50 (concentration causing 50 per 100 of inhibition of a given parameter, e.g. growth), NOEL/C (level/no observed effect concentration) or LOEL/C (level/minimum observed effect concentration).

41. an assessment factor is an expression of the degree of uncertainty in extrapolation of data from a trial with a limited number of species to the real environment. Therefore, in general, much broader being data and greater the duration of trials, the lower the degree of uncertainty and the size of the assessment factor.


Specifications for the assessment factors shall be elaborated in the notes for technical guidance which, to this end, shall be based, particularly on the indications given in article 4 and annex X of Royal Decree 363/1995, of 10 March, which approves the regulation on the notification of new substances and the classification, packaging and labelling of dangerous substances.

42. for each environmental compartment an exposure assessment be carried out to predict the concentration that is likely to be found of each active substance or substance of concern 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 must then make a qualitative estimate of exposure.

43. only be determined a PEC or, where necessary, a qualitative estimation of exposure in the case of those environmental compartments in which are or are reasonably foreseeable emissions, discharges, disposal or distributions including any relevant contribution from material treated with biocidal products.

44 PEC, or qualitative estimation of exposure shall be calculated taking into account, in particular and where appropriate: the exposure data in the proper; the form of marketing of the product; the type of biocidal product; the method and the rate of application; physicochemical properties; the degradation/transformation products, the likely routes of arrival to environmental compartments and potential for adsorption/desorption and degradation; the frequency and duration of exposure.

45. in the assessment of the exposure it should pay special attention to the representative exposure data, measured properly, available. If calculation methods are applied, to establish exposure levels, adequate models must be used. The characteristics of these models shall comply with the provisions of paragraph 33.

In your case shall be taken also account, taken case by case, relevant data from the monitoring of substances use and exposure modes analogous or similar properties.

46. for any given environmental compartment, the risk characterisation shall entail, as far as possible, entail comparison of the PEC with the PNEC so that a PEC/PNEC ratio may be derived.

47. If it has not been possible to derive a PEC/PNEC ratio, the risk characterization shall entail a qualitative evaluation of the likelihood that or an effect will occur in the current or planned exposure conditions.

Unacceptable effects: 48. Data to the competent authority, which shall proceed to its assessment, to determine whether the biocidal product does not cause unnecessary suffering in its effect on vertebrates objective will be presented. This will involve an assessment of the mechanism by which gets the effect, as well as the observed effects on the behaviour and health of vertebrates for which it is intended; If the intended effect is the death of the vertebrate objective, the time required should be assessed to allow such death and the conditions in which occurs.

49. the Member State shall evaluate, where appropriate, the possibility of the Agency for which it is intended to develop resistance to an active substance of the biocidal product.

50 if there is evidence of the presence of any other unacceptable effects, the competent authority shall evaluate the possibility that such effects occur as, for example, an adverse reaction against closures and accessories used with wood following the application of a conservative of the wood.

Efficiency: 51. They must arise and evaluate data to corroborate the statements about the efficacy of the biocidal product. The data presented by the applicant or held by the competent authority must demonstrate the efficacy of the biocidal product with objectives organisms in normal use in accordance with the conditions of authorization.

52 trials shall be carried out according to Community guidelines if these are applicable and have them. In your case, you can follow other methods listed in the table below. If relevant acceptable field data, these may be.

(a) ISO, CEN or other international standard method.

(b) method of national standards.

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

(d) method of manufacturer standards (accepted by the competent authority).

(e) details of the very development of the biocidal product (accepted by the competent authority);

Summary: 53. In each of the fields in which is carried out a risk assessment, i.e., effects on human beings, animals and the environment, the competent authority will integrate the results obtained on the active substance with those obtained for any substance of concern to produce an overall assessment for the biocidal product itself. All the possible synergistic effects of active substances and possible risks of the biocidal product shall be taken into account.

54. to those biocidal products containing more than one active substance, adverse effects will also combine to get the global effects of the biocidal product itself.

General principles decisions: 55. Without prejudice to paragraph 96, the competent authority shall take a decision on the authorization of use of the biocidal product after integrating the risks arising from each active substance with the risks from each substance of concern present in the biocidal product.

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

56 to adopt the decision on the authorisation, the competent authority may choose one of the following conclusions for each product type and for each area of use of the biocidal product subject to which the application is lodged: 1) the biocidal product cannot be authorised.

(2) the biocidal product can be authorised subject to specific conditions/restrictions.

3) more data are required to proceed with your authorization.

57. If adopted by the competent authority concludes that additional information or more information required for the decision relating to the authorization, the need for such data or information must justify. Additional information or data shall be the minimum necessary to carry out a new risk assessment.

58. the Member State shall comply with the principles of mutual recognition pursuant to article 4 of the present Royal Decree.

59. the competent authority shall apply the rules concerning the concept of 'frame formulations' when adopting an authorisation decision on a biocidal product.

60. the competent authority shall apply the rules concerning the concept of 'low risk' products by adopting an authorisation decision on such a biocidal product.

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

62. to grant authorizations, the competent authority shall impose, where appropriate, conditions or restrictions whose nature and severity will be established on the basis of the nature and extent of the advantages and risks provided in connection with the use of the biocidal product.

63. in the adoption of decisions, the competent authority shall take into account the following: the results of the evaluation of the risk, in particular the relationship between exposure and effect; the nature and severity of the effect; the risk management which can be applied; the scope of use of the biocidal product; the efficacy of the biocidal product; the physical properties of the biocidal product; the advantages offered by the use of the biocidal product.

64. to adopt a decision concerning 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 evaluation and adoption of the decision process.

65. the competent authority shall prescribe the proper use of the biocidal product. This proper use will consist of an effective dose of application and, wherever possible, to minimize the use of biocides.

66 before granting an authorisation, the competent authority shall take the necessary measures to ensure that the applicant proposes a label of the biocidal product and, where appropriate, the corresponding tab of data security for the biocidal product which: a) meets the requirements of articles 19 and 20 of the present Royal Decree.

(b) it contains information relating to the protection of users required by Community legislation on the protection of workers.

(c) specify expressly the conditions or restrictions depending on which can or the biocidal product cannot be used.

Before issuing an authorization, the competent authority shall confirm that they must satisfy these requirements.

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

Effects in humans: 68. The competent authority shall not authorise a biocidal product if the risk assessment confirms that, even in the most unfavorable realistic course of foreseeable implementation, the product presents an unacceptable risk to human.


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

70. the competent authority shall examine the relationship between the exposure and the effect, and apply it to the adoption of the decision. Several factors are involved in the examination of this relationship, and one of the most important is the nature of the adverse effect of the substance. These effects may be acute toxicity, irritation, corrosivity, sensitisation, toxicity repeated doses, genotoxicity, carcinogenicity, neurotoxicity, toxicity for reproduction, together with physico-chemical properties, and any other property adverse of the active substance or substance of concern.

71. as far as possible, the competent authority will compare the results obtained with the of previous risk assessments conducted on identical or similar effects, and shall take a decision with an adequate margin of safety by adopting its decision of approval.

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

72. the competent authority may, where necessary, impose as a condition for authorizing the use of personal protection, like respirators, face masks, clothing, gloves and safety glasses to reduce the exposure of professional users, which should be readily available of such equipment.

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

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

75 will not be authorized for use by the public in general no biocidal product classified according to paragraph 1 of article 19 of the present Royal Decree, as toxic, very toxic or as a carcinogen category 1 or 2 mutagen, or classified as toxic for reproduction of category 1 or 2.

Effects in animals: 76. The competent authority shall not authorise a biocidal product if the risk assessment confirms that, under normal authorization, the product presents an unacceptable risk for animals that is not intended.

77. using the same relevant criteria described in the part dealing with effects on humans, the competent authority shall take into account the risks that the biocidal product presents for animals to adopt the decision on the authorisation of 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 concern, or any degradation, or reaction product presents an unacceptable risk to any of the environmental compartments, water (including sediment), soil and air. Here will include risk assessment for the agencies to which it is not intended in these compartments.

In considering whether there is an unacceptable risk, the competent authority, having to take a final decision pursuant to section 96, it shall take into account the criteria in paragraphs 81 to 91.

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

The most appropriate model should be used to determine the PEC, taking into account what is happening with the biocidal product on the environment and their behaviour in such medium.

80. for any given environmental compartment, if the PEC/PNEC ratio is equal to or less than the unit, the risk characterisation shall be that don't need more information or new evidence.

If the ratio is higher than the unit, the competent authority shall judge based on the magnitude of the ratio and on other relevant factors, if further information is required or new evidence to clarify the question or if necessary risk mitigation measures are or if not you can be granted permission to the product.

Relevant factors to be considered are listed 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 of any other substance of concern and relevant metabolites or products of degradation or reaction in water (or its sediments) has an unacceptable consequence on species that is not intended in the aquatic environment Marine or estuarine, unless it is scientifically proven that there is no unacceptable under relevant field conditions effect.

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 of any other substance of concern or relevant metabolites or products of degradation in surface waters exceeds the lower of the following concentrations: to) the maximum permissible concentration which establishes the regulations on the quality of water intended for human consumption.

(b) the maximum concentration as set according to the procedure to include the substance active in annexes I, IA or IB to this Royal Decree on the basis of appropriate data, in particular toxicological data, unless proven scientifically that that lower concentration is not exceeded under relevant field conditions.

83 the competent authority shall not authorise a biocidal product if the foreseeable concentration of the active substance and any substance of concern or of relevant metabolites or degradation or reaction products that present surface water or its sediments after use of the biocidal product under the proposed conditions of use: a) exceeds, where the waters surface in the area of possible application of biocide (or from it) are intended for the production drinking water, established values.

(b) by Directive 75/440/EEC of the Council of 16 June 1975 concerning the quality required for surface water intended for the abstraction of drinking water in the Member States, transposed to our legal system through regulation of public water management (annex I); Order of 11 May 1988, on rivers. Basic characteristics of quality which must be kept on the surface currents for the production of drinking water, order of 15 May 1990, waters. It modifies the order of 11 May 1988, of basic characteristics of quality which must be kept on the surface currents for the production of drinking water, order of 30 November 1994, waters. Modifies the order of 11 May 1988, on basic characteristics of quality that must be kept in the currents of inland surface waters intended for the abstraction of drinking water, and Royal Decree 1541 / 1994, waters. Modify Annex 1 to the regulation of the Administration public water and the hydrological planning, approved by the Royal Decree 927/1988, of July 29.

(c) by the regulations on the quality of water intended for human consumption, Real Decree 1138 / 1990 of 14 September, which approves the Reglamentación for supply and quality control of drinking water for public consumption.

(d) it has a considered unacceptable effect for species that is not intended, unless it is scientifically demonstrated that under relevant field conditions this concentration is not exceeded.

84. the instructions for use of the biocidal product proposals, including the cleaning of utensils application procedure, should help minimize the possibility of accidental contamination of water or its sediments.

Soil: 85. Where unacceptable contamination of soil is likely to occur, the Member State shall not authorise a biocidal product if, after using this in the conditions laid down, the active substance or substance of concern contained, during the field trials persist in soil for more than one year, or during laboratory tests, form non-extractable residues in amounts exceeding 70 per 100 of the initial dose after 100 days with a rate of mineralization below the 5 per 100 in 100 days, consequences or unacceptable effects on organisms that is not intended, unless it is scientifically demonstrated that under field conditions, there is no unacceptable accumulation in soil.

Air: 86. The competent authority shall not authorise a biocidal product where there is a foreseeable possibility of unacceptable effects on the atmospheric compartment, occur unless it is scientifically proven that there is no unacceptable under relevant field conditions effects.

Effects on the organisms that is not intended: 87. The competent authority shall not authorise a biocidal product where there is a reasonably foreseeable possibility of organisms that is intended not being exposed to the biocidal product if, with respect to any active substance or substance of concern: the PEC/PNEC ratio is greater than the unit, unless it is clearly established in the risk assessment that under field conditions no unacceptable effects by the use of the biocidal product under the proposed conditions of use occur , or,


The bioconcentration factor (BCF corresponding to the fatty tissues of vertebrates for which it is intended) is superior to the unit, unless it is clearly established in the risk assessment that under field conditions, do not occur directly or indirectly unacceptable effects by the use of the biocidal product under the proposed conditions of use.

88. the competent authority shall not authorise a biocidal product where there is a reasonably foreseeable possibility of aquatic organisms including marine and estuarine, organisms being exposed to the biocidal product if for any active substance or substance of concern in it including, the PEC/PNEC ratio is greater than the unit, unless it is clearly established in the risk assessment in field conditions the viability of aquatic organisms including marine and estuarine, it is not threatened by the biocidal product under the proposed conditions of use; or the bioconcentration factor (BCF) is greater than 1000 for substances readily biodegradable or greater than 100 for those which are not easily biodegradable, except that marine organisms is clearly established in the assessment of the risk that under field conditions there is no direct or indirectly an unacceptable impact on the viability of exposed organisms including and estuary , by the use of the biocidal product under the proposed conditions of use.

Notwithstanding the provisions of this paragraph, the competent authority may authorise, however, an anti-fouling product used in boats, maritime, commercial and public service, for a period of up to ten years from the date on which it enters into force this Royal Decree, if cannot be performed by other applicable means anti-fouling control. When applying this provision, the competent authority shall take account, where appropriate, the relevant resolutions and the recommendations of the International Maritime Organization (IMO).

89. the competent authority shall not authorise a biocidal product where there is a reasonably foreseeable possibility of micro-organisms in sewage treatment plants are exposed to the biocidal product if, due to any active substance or of concern, relevant metabolite, degradation or reaction product the PEC/PNEC ratio is greater than 1, unless it is clearly established in the risk assessment that there is no unacceptable consequences , directly or indirectly, on the viability of such micro-organisms under field conditions.

Unacceptable effects: 90. If expected the development of resistance to the active substance of the biocidal product, the competent authority shall take the necessary measures to minimize the consequences of this resistance. This can involve modifying the conditions of authorisation or even its rejection.

91 only shall be granted authorisation for a biocidal product intended to control vertebrates when: to) the death occurs simultaneously with the extinction of consciousness, or appearance of suffering.

((b) the death occurs immediately, or c) vital functions are reduced gradually without signs of apparent suffering.

For repellent products, the intended effect shall be obtained without unnecessary suffering and pain vertebrate for which it is intended.

Efficiency: 92. The competent authority shall not authorise a biocidal product which does not have acceptable efficacy when used in accordance with the conditions specified on the proposed label or with other conditions of authorisation.

93. the level, consistency and duration of control or protection or other desired effects must be similar, at least, derivatives of other suitable products of reference where such products exist, or to other means of control. There is no any product reference, the biocidal product must provide a defined level of protection in the areas of proposed use or control. The conclusions as to the performance of the biocidal product must 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 specific circumstances. The competent authority shall evaluate dose response data generated in tests (which must include a control untreated) in which to intervene below the recommended proportion proportions, in order to assess if the recommended dose is the minimum necessary to achieve the desired effect.

Summary: 94. In each of the fields that have been carried out risk assessments, i.e. effects on man, animals and the environment, the competent authority must integrate the conclusions it reached concerning the active substance and the substances of concern to produce an overall conclusion for the biocidal product itself. In addition, there should be a summary of the evaluation of the effectiveness and the unacceptable effects.

The result will be an overview of: the effects of the biocidal product on humans, the effects of the biocidal product on animals, the effects of the biocidal product on the environment, the evaluation of the effectiveness, the unacceptable effects.

Overall integration of conclusions 95. The competent authority will integrate the conclusions they reached with respect to the effects of the biocidal product on the three sectors concerned, humans, animals and the environment, to elaborate a general conclusion about the global effect of the biocidal product.

96. before to proceed with the decision concerning the authorisation of a biocidal product, the competent authority shall take due account any unacceptable effect of consideration, the efficacy of the biocidal product and the benefits of its use.

97. the competent authority will decide ultimately whether you can proceed to the authorisation of the biocidal product and whether such permission should be subject to certain restrictions or conditions, in accordance with this annex and the Royal Decree.

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