Article 45 of Law 43/2002 of 20 November 2002 on Plant Health establishes the framework applicable to plant health protection means other than plant protection products and biological control organisms. The marketing of such means shall require prior communication to the competent authority of the Autonomous Community, giving the latter to the Ministry of Agriculture, Food and Environment for registration in the Official Register of Plant protection products and materials, unless the requirement for prior authorisation is applicable to them.

And by Order APA/1470/2007 of 24 May, which regulates the marketing communication of certain means of plant health protection, Chapter IV of Title III of Law 43/2002, of 20 of the November, for Plant Health, for the placing on the market and use of biological control organisms and other plant protection means other than plant protection products.

Following these regulatory texts, Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 on the protection of plant protection products has been published in this field the placing on the market of plant protection products and repealing Council Directives 79 /117/EEC and 91 /414/EEC. In accordance with that legislation, as well as with the criterion set out by the European Union Commission in respect of the products covered by it, and therefore subject to administrative authorisation, it is necessary to bring the rules into line with the (a) national regulatory authority to that of the European Union, in such a way as to clarify that the means of plant health protection provided for in Article 45 of Law 43/2002, of 20 November, and which may be marketed without prior authorisation are the non-exotic biological control, traps, and other means or monitoring devices.

In this way, operators who wish to place on the market the aforementioned means of plant health protection will inform the competent administration, showing that not only are all the requirements required In addition, the placing on the market of the same is done under the sole responsibility of the operator, to whom it is incumbent to have the information accrediting of the required requirements. This prior notice complies with the principles of necessity and proportionality provided for in Article 17 (3) of Law 20/2013 of 9 December 2013 on the guarantee of the market unit, where necessary, for the overriding reasons for the protection of the environment. environment, know the number of economic operators and the products placed on the market.

Except for the prior communication regime, and subject to authorization, exotic biological control organisms.

Logically, this regulation should be without prejudice to other sectoral rules that may be applicable, for example if the product contained a GMO, etc.

Therefore, the necessary transitional provisions are also envisaged for the products which will be discharged in the Register and which have been marketed so far under the Order APA/1470/2007, 24 of May, always within due guarantees.

Given the entity of the changes, a new rule has been chosen, for reasons of legal certainty.

In the procedure for drawing up this provision, the autonomous communities and representative entities of the sectors concerned have been consulted.

This royal decree has been submitted to the procedure for information on technical standards and regulations, provided for in Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998, as well as in the Royal Decree Decree 1337/1999 of 31 July regulating the provision of information in the field of technical standards and regulations and regulations relating to the services of the information society.

This royal decree is dictated by the habilitation contained in the final provision of Law 43/2002, dated November 20.

In its virtue, on the proposal of the Minister of Agriculture, Food and Environment, with the prior approval of the Minister of Finance and Public Administrations, according to the State Council and prior deliberation of the Council of Ministers at its meeting on 14 November 2014,

DISPONGO:

Article 1. Object and scope of application.

1. The purpose of this royal decree is to establish the requirements for the marketing of certain means of phytosanitary protection, and to regulate the communication required for the same, as referred to in Articles 44 and 45 of Law 43/2002, of 20 of November, for Plant Health, as well as its official register for the knowledge of Public Administrations and any other interested parties.

2. The biological control bodies, traps and other monitoring devices that are not directly linked to pest control, hereinafter the MDFs, are included in their scope exclusively.

3. They are expressly excluded from the scope of this royal decree:

(a) The substances, products and preparations falling within the scope of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing on the market of products plant protection and repealing Council Directives 79 /117/EEC and 91 /414/EEC in the field of which products may be included which may favour the development of crops or resistance against adverse effects related to the use of the attacks of pathogens, or of environmental conditions, or allow to mitigate in another way the havoc that they can cause, as well as in the development regulations of the same.

(b) The substances and preparations falling within the scope of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the placing on the market and use of biocidal products.

(c) Fertilizers, regulated by European Union legislation for the placing on the market of all fertilizer materials, including inorganic fertilizers, organic fertilizers, crop substrates, soil improvers and bio-stimulants, or, where appropriate, by Royal Decree 506/2013 of 28 June 2013 on fertilising products, as well as products which, in their composition, include one or more types of those provided for in Annex I to Royal Decree 506/2013, 28 June, or in Annex I to Regulation (EC) No 2003/2003.

(d) The means of application of plant protection products, regulated by Royal Decree 1702/2011 of 18 November 2011, of periodic inspections of equipment for the application of plant protection products.

4. The provisions of this royal decree shall be without prejudice to compliance with the other provisions applicable to the product concerned, including:

(a) The rules on the classification, packaging and labelling of dangerous substances and preparations for the substances or products concerned by it.

(b) The use of names, as regards the trade name, of the names, names, logos or other identifying images of the companies, registered in accordance with the provisions of Law 17/2001 of 7 December, of Marks.

c) The rules on genetically modified organisms.

(d) Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the registration, assessment, authorisation and restriction of chemical substances and mixtures (REACH).

Article 2. Requirements.

The requirements for the marketing of MDFs regulated by this royal decree are as follows:

(a) They are effective for the uses and crops to which they are intended, depending on the recommended conditions of use.

(b) That, under the conditions of use referred to in point (a), comply with the provisions of Article 45 (1) of Law 43/2002 of 20 November of Plant Health.

(c) That their components have the due quality or purity, and that, as a whole, each MDF responds to the specifications declared by its producer or manufacturer.

For the purposes referred to in points (a), (b) and (c), the manufacturer or commercial operator shall have the studies, tests or other relevant documentation available to the manufacturer or operator to demonstrate compliance with those requirements.

Article 3. Prior communication.

1. Operators who produce or are responsible for the placing on the market of one or more MDFs, except in the case of Article 4, shall submit a prior notice, in the model provided for in Annex I. A, for each MDF, together with the supporting document. the payment of plant health fees in accordance with Article 67 of Law 43/2002 of 20 November.

2. Communications, which may be submitted by electronic means, shall be addressed to:

(a) The Directorate-General for Health of Agricultural Production of the Ministry of Agriculture, Food and the Environment, in the event that they refer to MDF that are biological control organisms.

(b) The competent authority of the autonomous community where the operator concerned has its registered office, or where it radiuses the headquarters of its effective address in Spain, for declarations referring to the rest of MDF.

3. The autonomous communities shall examine the communications received in accordance with paragraph 2 (b) and shall send them to the Directorate-General for Agricultural Production of the Ministry of Agriculture, Food and the Environment, accompanied by a report with at least the data provided for in Annex II. The transmission of the communications with their corresponding reports shall be produced within a maximum of one month from the day following the receipt of the correctly completed communication.

The National Phytosanitary Committee will have to prepare and propose, where appropriate, the necessary guidelines for the harmonization of criteria for the examination of communications and products that can be considered as MDF for the completion of those reports.

4. In the same way as for the placing on the market will be carried out when modifications are intended to be made to an MDF marketed.

In the declaration of modifications that do not affect the nature and properties of the plant protection environment, an explanation of the reason for such modifications shall be included.

Article 4. Exotic biological control organisms.

1. In accordance with Articles 44 and 45 of Law 43/2002 of 20 November 2002, the marketing regime referred to in Article 3 (1) does not apply to exotic biological control organisms for which it is intended to be used for the purposes of requires prior authorization and registration in the Registry.

To this end, the Directorate General for Health of Agricultural Production must require a report from the competent organ of the General Administration of the State in the field of biodiversity conservation, for which it will request The person concerned shall provide the necessary supporting documents to be considered by the said organ.

It shall be adopted by express resolution within the maximum period of six months, counted from the receipt in the Directorate General of Health of Agricultural Production of the Ministry of Agriculture, Food and Environment, of the request of the data subject.

2. Operators shall submit the appropriate application in the model provided for in Annex I. B, for each exotic biological control body, accompanied by the supporting evidence for the payment of plant health fees in accordance with Article 67 of Law 43/2002, 20 November, and timely documentation.

Article 5. Marketing and registration.

1. In the registration of the MDFs in the respective section of the Official Register of Products and Plant Health of the Ministry of Agriculture, Food and the Environment, the data from the communication or from the the authorisation, as well as the registration number, to be notified to the data subject, and the information shall be kept in a computerised system to facilitate its public consultation, with the exception of any personal data or which may constitute industrial or commercial secrecy. The registration data may also be issued with the corresponding certificates or simple notes at the request of the interested parties.

2. Once the prior communication, duly completed in all its content, has entered the register of the competent body in each case, as referred to in Article 3, or which has been notified in accordance with Article 4, the corresponding authorisation, the operator may market the corresponding MDF.

The Directorate General of Health of Agrarian Production will proceed to the registration in the respective section of the Official Register of Products and Plant Health of the Ministry of Agriculture, Food and Environment, the MDFs whose prior communication, duly completed in their entirety, has entered the register of the competent body in each case referred to in Article 3, or which have been authorised in accordance with Article 4.

The MDFs that are marketed will be identified with the corresponding label or when, by their nature, they do not correspond to their labelling, for the information necessary for their correct use and maintenance. Once the MDF registration number is available, the label or information accompanying the MDF registration number must also be accompanied by the instructions for use and storage. These data and information shall be written in Spanish at least, and shall contain accurate and sufficient information on their essential characteristics and the recommendations for use. This is without prejudice to compliance, in the cases where this was the case, in the field of labelling, of Royal Decree 255/2003 of 28 February 2003 adopting the Regulation on the classification, packaging and labelling of dangerous preparations, until 1 June 2015, and from that date, of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures and amending and repeal Directives 67 /548/EEC and 1999 /45/EC and amend Regulation (EC) No 1907/2006.

3. If at any time it is noticed that an MDF registered prior to the communication of its owner, it is actually an exotic biological control body, or that it is not an MDF, of its own initiative, due to denunciation, by communication of the communities The Directorate-General for Health of Agricultural Production shall give the commercial operator the right to immediate withdrawal from the market and shall notify the commercial operator thereof. If it is an exotic biological control body, it shall not be remarketed until it has been submitted and has obtained the relevant authorisation where appropriate. Such a decision shall also be notified to the autonomous community in which the appropriate communication was submitted by the undertaking.

4. The inaccuracy, falsehood or omission, of an essential nature, in any data or manifestation included in the communication or in the application or supporting documentation, the failure to comply with any of the requirements laid down in Article 2; or (a) to the competent authority of the requested information or documentation, shall determine the impossibility of marketing the MDFs concerned, as soon as such facts are known, without prejudice to the criminal, civil, administrative or other order responsibilities, to which there would be.

5. The Directorate-General for Health of Agricultural Production shall review the entries or authorizations when:

(a) The requirement of new requirements for the advancement of scientific and technical knowledge should be regulated.

(b) Failure to comply with any requirement of the requirements of Article 2.

c) The information in which they are supported contains false or misleading elements.

d) The MDFs that are marketed do not respond to the declared features or specifications.

e) The information or documentation required to perform the review is not referred to the competent Administration.

f) So be proposed by the autonomous communities for plant health reasons.

The revision of the registrations or authorizations, the initiation of which will be notified to the operators concerned, and the autonomous community in which the responsible statement or the communication was presented by the company, may have as consequences the maintenance, modification, suspension or cancellation of the same.

6. Without prejudice to official controls which, in accordance with Law 43/2002 of 20 November 2002, are carried out on the production, marketing and use of the MDFs, the Directorate-General for Health of Agricultural Production shall include, in coordination with the bodies responsible for the matter, within the framework of the surveillance programmes carried out pursuant to Article 68 of Regulation (EC) No 1107/2009, a specific monitoring of the registration or authorisations for the intended purposes of the previous paragraph, requiring the operators concerned to do so appropriate justification.

Article 6. Infringements and penalties.

In the event of non-compliance with the provisions of this royal decree, the sanctioning regime provided for in Law 43/2002 of 20 November, and the other provisions that are applicable, will apply.

Additional disposition first. Mutual recognition.

Retains its validity the principle of mutual recognition to products legitimately manufactured or marketed in other countries of the European Union, in the countries that are signatories to the Agreement on the European Economic Area and in States which have a Customs Association Agreement with the European Union, in accordance with their own rules and accompanied by the corresponding supporting documentation, prior to their placing on the Spanish market.

Additional provision second. Products intended exclusively for export.

Those products that are manufactured exclusively for export, and do not meet the requirements of this royal decree for registration in the MDF registration, must be labelled in such a way as to make it clear that their only target is the export.

Single transient arrangement. Regularisation of currently registered MDFs and marketing deadlines.

1. The MDFs that are registered in the MDF section of the Official Register of Products and Plant Health of the Ministry of Agriculture, Food and the Environment and fall within the scope of the present royal decree as biological control bodies, traps or other means or monitoring devices and are being marketed at the time of the entry into force of this royal decree, shall remain registered as such and may continue to be placed on the market.

However, the holders of all these products must submit to the Directorate General of Health of the Agricultural Production within the maximum period of six months from the entry into force of this royal decree, the all the data contained in Annex I. A or I. B of this royal decree. If the deadline does not present the relevant information, the cancellation of the registration of the product will occur as MDF and the impossibility of its marketing. In this case, it will be dictated, in application of this royal decree and without the need for an audience, not to be taken into account other facts, allegations or documents that the ones presented by the interested party, the timely resolution of cancellation of the registration of the product, by the Directorate-General for Health of Agricultural Production, in which, except in the case of non-compliance with the requirement laid down in Article 2 (b) or risk for animal welfare, a period of two months shall be provided. for sale and sale, and a total of four for use, always counted from the notification of that resolution.

2. The holders of the MDFs who are registered in the MDF section of the Official Register of Plant Health Products and Material of the Ministry of Agriculture, Food and the Environment, other than those referred to in paragraph 1. has been excluded from the scope of this Royal Decree pursuant to Article 1 (3), or because it is not a biological control body, traps or other monitoring devices, and has been excluded from the scope of this Regulation. they are marketing, at the time of the entry into force of this royal decree, they must present to the Directorate-General for Health of Agricultural Production within the maximum period of six months from the entry into force of this royal decree, the information relating to the data in Annex I. A which they would not have previously provided, accompanied by a manufacturer's certificate with respect to the exact composition of the product, and a bulletin of analysis on the exact composition of the product, issued by laboratory evaluated and accredited in accordance with UNE-EN ISO/IEC 17025.

If this time limit does not present all the relevant information and documentation, the cancellation of the registration of the product will occur as MDF and the impossibility of its marketing. In this case, it will be dictated, in application of this royal decree and without the need for an audience, not to be taken into account other facts, allegations or documents that the ones presented by the interested party, the timely resolution of cancellation of the the registration of the product by the Directorate-General for the Health of Agricultural Production, without the possibility of a period of manufacture, marketing, sale or use of the product on the basis of the notification of that resolution.

With regard to the MDFs whose owners submit such information within six months, it will be made out of hand, in application of this royal decree and without the need for a hearing, in the absence of other facts, allegations or documents submitted by the person concerned, the appropriate resolution of cancellation of the registration of the product, by the Directorate General of Health of the Agricultural Production, in which they shall be provided, except in the case of non-compliance with the requirements provided for in Article 2 (b) or risk for animal welfare, the following time-limits, always counted since the notification of that resolution.

(a) If the information provided by the company, or the manufacturer's certificate or the analysis bulletin referred to in the first subparagraph of this paragraph, the existence of an active substance is derived from the product included in Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011, or the inclusion of which has been rejected by the European Commission, or which the product includes at least one type of those provided for in Annex I to the Royal Decree 506/2013 of 28 June, or Annex I to Regulation (EC) No 2003/2003, a period of two months shall be provided for the marketing and sale of the product, and a total of four for use.

(b) In all other cases, a period of eighteen months shall be provided for the manufacture, placing on the market, sale and use of the product.

Single repeal provision. Regulatory repeal.

Order APA/1470/2007 of 24 May, which regulates the marketing communication of certain means of plant health protection, is hereby repealed.

Final disposition first. Competence title.

This royal decree is issued under the terms of Article 149.1.13., 16. and 23. of the Spanish Constitution, which attributes to the State exclusive competence on the basis and coordination of the general planning of economic activity, (a) basic and general coordination of health, and basic legislation on environmental protection, respectively.

Except for the regulation contained in the second provision and the corresponding sanctioning regime, which is dictated by the article 149.1.10. and 16. first indent, of the Spanish Constitution, which it attributes to the State exclusive competence on, respectively, external trade and external health.

Final disposition second. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, on November 14, 2014.

FELIPE R.

The Minister of Agriculture, Food and the Environment,

ISABEL GARCÍA TEJERINA

ANNEX I

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ANNEX II

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