Key Benefits:
Publics concerned: manufacturers of biocide active substances, producers and users of biocide products, manufacturers, importers, users and exporters of chemicals.
Purpose: modalities for approval, market availability and reporting of biocide products and biocide active substances.
Entry into force: the text comes into force on the day after its publication.
Notice: Biocides are chemical or biological substances or mixtures containing them, intended to destroy, repel or render harmful organisms harmless, to prevent or combat their action. The use of these products and substances is controlled, because of the dangers they may present. The European Regulation No. 528/2012 of 22 May 2012 introduced new procedures to strengthen human and environmental protection, accelerate the assessment process of active substances and simplify the authorization to market products. This Decree adapts national regulations to these new requirements. In particular, between the assessment phase and the decision phase, it distributes the deadlines set by the European Regulation to issue authorizations or prepare for approval of a substance. The entire procedure for assessing substances and products is entrusted to the National Food, Environment and Labour Safety Agency (ANSES). The decision to market a product is for the Minister responsible for the environment. As part of a process of mutual recognition between Member States, such a decision may be taken in the absence of an opinion issued by the ANES within the time limit. In this case, the Minister's decision will be based on the decision issued for the same product by the Member State in charge of the assessment. The decree also provides for the possibility of stopping measures of general scope by damaging certain types of biocide products, in order to simplify the issuance of marketing authorizations on the individual market. Finally, he is adapting the composition and tasks of the Chemicals and Biocides Commission, which is placed with the Minister for the Environment.
References: this decree is taken for the application of the articles 12 and 13 Act No. 2013-619 of 16 July 2013 on various provisions for adaptation to European Union law in the field of sustainable development. It is available on the website Légifrance (http://www.legifrance.gouv.fr).
The Prime Minister,
On the report of the Minister of Ecology, Sustainable Development and Energy,
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and the amended Council of 18 December 2006 concerning the registration, assessment and authorization of chemical substances, as well as the restrictions applicable to these substances (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 of the Council and Regulation (EC) No. 1488/94 of the EEC
Having regard to amended Regulation (EC) No. 1451/2007 of 4 December 2007 concerning the second phase of the 10-year programme of work referred to in Article 16, paragraph 2, of Directive 98/8/EC of the European Parliament and of the Council on the marketing of biocide products;
Considering the amended Regulation (EU) No. 528/2012 of the European Parliament and Council of 22 May 2012 concerning the provision on the market and the use of biocide products;
Considering the Commission's Implementing Regulation (EU) No. 354/2013 of 18 April 2013 on amendments to biocide products authorized in accordance with Regulation (EU) No. 528/2012 of the European Parliament and the Council;
Considering the Commission's Implementing Regulation (EU) No. 414/2013 of 6 May 2013 specifying a procedure for authorizing the same biocide products in accordance with Regulation (EU) No. 528/2012 of the European Parliament and the Council;
Vu le Consumer codeincluding article L. 411-1;
Vu le environmental codeincluding articles L. 120-1 and L. 141-1 and title II of Book V (legislative and regulatory parties);
Vu le Criminal code ;
Vu le Public Health Codeincluding articles L. 1114-1, L. 1313-1, L. 1341-1, L. 1342-2, R. 1333-4, R. 1333-18, R. 1342-13 and R. 1342-15;
Vu le Labour codeincluding article L. 4411-4;
Vu la Act No. 2013-619 of 16 July 2013 bringing various provisions for adaptation to European Union law in the field of sustainable development, including Article 13;
Vu le Decree No. 97-1204 of 19 December 1997 amended for application to the Minister for the Environment first paragraph of Article 2 of Decree No. 97-34 of 15 January 1997 the deconcentration of individual administrative decisions;
Vu le Decree No. 2006-672 of 8 June 2006 modified on the establishment, composition and functioning of administrative advisory commissions;
Vu le Decree No. 2006-781 of 3 July 2006 Amending the terms and conditions for the payment of costs incurred by the temporary movement of civil personnel of the State;
Vu le Decree No. 2009-620 of 6 June 2009 amended on certain advisory boards under the Ministry of Ecology, Energy, Sustainable Development and Land Management;
Vu le Decree No. 2009-1685 of 30 December 2009 amended on transitional market authorizations for certain biocide products and various provisions for adaptation to community law in the field of the environment;
The State Council (section of public works) heard,
Decrete:
Title II of Book V of the Environmental Code (regulatory part) is amended in accordance with the provisions of Articles 2 to 4 of this Order.
Chapter II is replaced by the following:
“Chapter II
"Approval of biocide active substances and authorization to make available on the market biocide products
"Art. R. 522-1.-I.-The approval of biocide active substances, the provision on the market of biocide products and articles treated by these products and their testing under the conditions set out in I of Article L. 522-1 are subject to the provisions of this chapter.
"II.-The Minister for the Environment is, unless otherwise provided, the competent authority referred to in 1 of Article 81 of Regulation (EU) No 528/2012 of the European Parliament and of the amended Council of 22 May 2012 concerning the provision on the market and the use of biocide products.
"Art. R. 522-2.-Exemptions to Regulation (EU) No. 528/2012 of the European Parliament and the Council of 22 May 2012 referred to in Article L. 522-1 are issued by joint decision of the Minister of Defence and the Minister responsible for the environment, except in cases of operational emergency for which the decision is taken by the Minister of Defence who informs the Minister responsible for the environment. In both cases, the Minister of Defence may delegate his power by order.
"The decision is notified to the applicant. It specifies the biocide product or the treated article concerned, as it contains a certain active substance, the duration of the exemption and, where applicable, the conditions under which a new joint decision of the Minister of Defence and the Minister responsible for the environment could be issued.
"In the absence of an explicit decision after six months of receipt of the application, the application is deemed to be rejected.
"A joint order of the Minister for the Environment and the Minister of Defence specifies the conditions for the submission and instruction of applications.
“Section 1
"Approval and renewal of approval of biocide active substances
"Subsection 1
"Instruction of records for approval or renewal of approval of biocide active substances
"Art. R. 522-3.-I.-When France is the competent authority to assess pursuant to Articles 7 or 13 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012, the applications for approval, modification of the conditions for approval or renewal of approval of biocide active substances are transmitted by the applicant using the register referred to in Article 71, paragraph 3.
"II.-The National Agency for Health Safety of Food, Environment and Labour, referred to inArticle L. 1313-1 of the Public Health Code, below referred to as “the National Agency”, examines the application under the conditions provided for in Article 7 of Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 referred to above. It informs the Minister responsible for the environment, other competent authorities of the Member States, the European Chemicals Agency and the applicant for the validation of the application.
"III.-In the event that the application is not validated, the National Agency shall notify the Minister responsible for the environment at least 15 days before informing the Minister, except as opposed to the Minister, the European Chemicals Agency and the applicant.
"IV.-If the application is validated, the National Agency shall conduct its assessment in accordance with Article 8, in the case of an application for approval or amendment of the conditions for approval of biocide active substances, or Article 14, in the case of an application for renewal of approval, Regulation (EU) No 528/2012 of the European Parliament and Council of 22 May 2012 referred to above. It is the recipient of additional information referred to in Article 8, paragraph 2, of the Regulations.
"At the end of the assessment, the National Agency shall inform the Minister responsible for the environment of its conclusions at least five working days before transmitting them, except as opposed by the Minister, to the European Chemicals Agency.
"Subsection 2
"Instruction of pre-authorization records to be made available on the market for a biocide product containing a new biocide active substance being evaluated
"Art. R. 522-4.-I.-The National Agency shall consider the request for interim authorization to make available on the market a biocide containing a new active substance being assessed pursuant to Article 55, paragraph 2, of Regulation (EU) No. 528/2012 of the European Parliament and the Council of 22 May 2012 referred to above.
"If the product meets the conditions laid down in 2 of this section, the National Agency shall transmit to the Minister responsible for the environment its conclusions, together with a draft summary of the characteristics of the product in accordance with 2 of Article 22 of Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 referred to above. The National Agency mentions, where appropriate, the reasons why it did not retain one or more of the applicant's claims.
"If the product does not meet the conditions set out in 2 of Article 55 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012, the National Agency shall transmit to the Minister responsible for the environment any reasoned conclusions thereof.
"The Minister responsible for the environment makes his decision in the light of the findings of the National Agency and, if necessary, after consultation with the Chemicals and Biocides Commission. It shall notify the applicant in accordance with the provisions of Article 71 of Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 referred to above.
"II.-At least 90 days prior to the expiry of the interim market authorization, the licensee may file an application for an extension to the National Agency in cases where the active substance is still being assessed. The National Agency examines the application under the conditions set out in Article 55, paragraph 2, of Regulation (EU) No. 528/2012 of the European Parliament and the Council of 22 May 2012 referred to above and transmits its findings to the Minister responsible for the environment who informs the applicant, the Commission and other Member States of the European Union.
“Section 2
"Authorizations for the availability of biocide products on the market
"Art. R. 522-5.-Decisions relating to the authorizations to be made available on the market for biocide products as well as decisions to renew or withdraw these authorizations made under the procedures set out in Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 referred to above and its implementing regulations are issued by the Minister for the Environment.
"Without specific provisions in this chapter, these decisions are issued after consultation with the National Agency.
"The records relating to applications for authorization or renewal of authorization to make available on the market of biocide products and any additional elements necessary for the examination of these applications are transmitted by means of the register referred to in Article 71, 3, Regulation (EU) No 528/2012 of the European Parliament and the Council of May 22, 2012 referred to above.
"Subsection 1
"Instruction of applications for national authorization to be made available on the market and renewal of national authorization for a biocide product when France is the reference Member State
"Art. R. 522-6.-I.-From the notification by the European Chemicals Agency of the verifications carried out pursuant to the 4 of Article 71 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 referred to above, when France is the reference Member State, the National Agency examines the request for national authorization to make available on the market of a biocide product and validates it It shall inform the applicant of the date of this validation.
"From that date, the National Agency has no more than 305 days to assess the application and, if it considers that the product meets the conditions set out in Article 19 of Regulation (EC) No 528/12 of the European Parliament and the Council of 22 May 2012 referred to above, update, in French and English, the draft summary of the characteristics of the product derived from the registry of biocide products. It shall forward to the Minister responsible for the environment this draft summary, together with a product assessment report that was previously consulted by the applicant for a period of 30 days, a summary of the results of this consultation and, where appropriate, a justification of the proposed restrictions in relation to the application filed. The 305-day period is extended if any of the suspensive period provided for in Article 30, paragraph 2, of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 referred to above.
"The draft summary of the characteristics of the product is also transmitted to the Minister of Labour when the application concerns a biocide product for exclusively professional use. The Minister shall notify the Minister of the Environment within 14 days of the date on which the summary of the characteristics of the product was transmitted to the Minister of the Environment and, in any event, the Minister responsible for the environment before the expiry of the deadline for making the decision. In the absence of a notice within these deadlines, the notice is deemed favourable.
"II.-After transmission of the documents referred to in the second paragraph of I, the Minister for the Environment shall consult with the applicant on his draft decision for a period of 5 days and notify the applicant, the Commission and other member States concerned of the European Union under the conditions provided for in Article 71 of Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 referred to above.
"Art. R. 522-7.-The application for the renewal of a national authorization to be made available on the market under Article 31 of Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 referred to above shall be dealt with in accordance with the procedure provided for in Article R. 522-6. However, if the National Agency considers that a comprehensive assessment is not necessary, the 305-day period referred to in this section is reduced to 120 days.
"Art. R. 522-8.-Where the National Agency has not forwarded the documents referred to in I of section R. 522-6 within the time limits referred to therein or within the time limits set out in section R. 522-7, it is deemed to have made unfavourable conclusions on the application submitted.
"Subsection 2
"Instruction of requests for mutual recognition of national authorizations to be made available on the market when France is not a reference Member State
“Paragraph 1
" Simultaneous Mutual Recognition Requests
"Art. R. 522-9.-I.-In the context of a request for simultaneous recognition of national authorization to be made available on the market of a biocide under Article 34 of the Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 referred to above, when France is not a member of reference, the Minister responsible for the environment may authorize a product based on the draft
"II.-The documents referred to in I are also transmitted to the Minister of Labour when the application for mutual recognition concerns a biocide product for exclusively professional use. The Minister shall notify the Minister of the environment no later than 10 days before the expiry of the deadline for making the decision. In the absence of a notice within these deadlines, the notice is deemed favourable.
“Paragraph 2
"Requests for sequential mutual recognition
"Art. R. 522-10.-I.-When France is not a reference Member State and it is seized of a request for mutual recognition sequential of national authorization to be made available on the market of a biocide product under Article 34 of the Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 referred to above, the Minister responsible for the environment
"II.-The documents referred to in I are also forwarded to the Minister of Labour when the application concerns a biocide product for exclusively professional use. The Minister shall notify the Minister of the environment 10 days before the expiry of the time limit for making the decision. In the absence of a notice within these deadlines, the notice is deemed favourable.
"Art. R. 522-11.-The requests for mutual recognition made by official or scientific bodies provided for in Article 39 of Regulation (EU) No. 528/2012 of the European Parliament and of the Council of 22 May 2012 referred to above are instructed in accordance with the provisions of this subsection.
"Subsection 3
"Instruction of requests to amend national authorization to make available on the market of a biocide product
“Paragraph 1
" Administrative amendment requests
"Art. R. 522-12.-In the event that the application for an amendment of a national authorization to be made available on the market involves an administrative amendment within the meaning of Title 1 of the Schedule to the Implementing Regulation (EU) No. 354/2013 of the Commission of 18 April 2013 relating to the modifications of biocide products authorized in accordance with Regulation (EU) No. 528/2012 of the European Parliament and of the Council, the National Agency shall have
"If, at the end of this period, the National Agency has not forwarded the documents referred to in the preceding paragraph, it is deemed to have made unfavourable conclusions on the application.
“Paragraph 2
"Requests for minor modification of authorization
« Sub-Paragraph 1
“Requests made when France is a Member State of Reference
"Art. R. 522-13.-I.-In the event that France is a reference Member State and where the request to amend an authorization to make available on the market of a biocide product is minor within the meaning of title 2 of the annex to the regulations of execution (EU) no 354/2013 of the Commission of 18 April 2013 already cited, the National Agency transmits to the Minister responsible for the environment, within a specified period of 75 days This period shall be extended if any of the suspensive period provided for in Article 7 5 of the Regulations.
"If the National Agency finds that the conditions set out in Article 19 of Regulation (EU) No. 528/2012 of the European Parliament and of the Council of 22 May 2012 already cited are not met, it shall transmit to the Minister responsible for the environment any reasoned conclusions and a product assessment report.
"II.-Where the National Agency has not forwarded the documents referred to in I within the time limits referred to therein, it is deemed to have issued unfavourable conclusions on the application.
« Sub-Paragraph 2
"Requests made when France is not a reference Member State
"Art. R. 522-14. - Within the framework of a request for mutual recognition of a minor amendment of national authorization to be made available on the market of a biocide product within the meaning of title 2 of the annex to the Regulation of execution (EU) no 354/2013 of the Commission of 18 April 2013 already cited, when France is not a member of reference, the Minister responsible for the environment may authorize a product based on the draft summary of
"Art. R. 522-15. -In the context of a request for a sequential mutual recognition of a minor modification of a national authorization to make available on the market of a biocide product within the meaning of title 2 of the annex to the regulation of execution (EU) no 354/2013 of the Commission of 18 April 2013 referred to above, when France is not a member of reference, the Minister responsible for the environment may authorize a product
“Paragraph 3
"Requests for major change of authorization
« Sub-Paragraph 1
“Requests made when France is a Member State of Reference
"Art. R. 522-16.-I.-In the event that France is a reference Member State and where the request to amend an authorization to make available on the market of a biocide product is major within the meaning of Title 3 of the annex to the Regulation of execution (EU) No 354/2013 of the Commission of 18 April 2013 already cited, the National Agency transmits to the Minister responsible for the environment, within 120 days This period shall be extended if any of the suspensive period provided for in Article 8, 5 of the Regulations.
"If the National Agency finds that the conditions set out in Article 19 of Regulation (EU) No. 528/2012 of the European Parliament and of the Council of 22 May 2012 already cited are not met, it shall transmit to the Minister responsible for the environment any reasoned conclusions and a product assessment report.
"II.-Where the National Agency has not forwarded the documents referred to in I within the time limits referred to therein, it is deemed to have issued unfavourable conclusions on the application.
« Sub-Paragraph 2
"Requests made when France is not a reference Member State
"Art. R. 522-17. -In the context of a request for simultaneous mutual recognition of a major modification of national authorization to be made available on the market of a biocide product within the meaning of title 3 of the annex to the Regulation of execution (EU) no 354/2013 of the Commission of 18 April 2013 already cited, when France is not a member of reference, the Minister responsible for the environment may authorize a product based on the draft summary of characteristics
"Art. R. 522-18. -In the framework of a request for mutual recognition sequential of a major modification of a national authorization to make available on the market of a biocide product within the meaning of title 3 of the annex to the regulation of execution (EU) no 354/2013 of the Commission of 18 April 2013 already cited, when France is not a member of reference, the Minister responsible for the environment may authorize a product
"Subsection 4
"Instruction of applications for authorization to make a biocide product available on the European Union market
"Art. R. 522-19.-When an applicant wishes France to be the competent authority for the evaluation of a biocide product under Chapter VIII of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 or Chapter III of the Implementing Regulations (EU) No 354/2013 of the Commission of 18 April 2013 already cited, he shall forward his application to the National Agency which shall make such an assessment.
"The National Agency shall inform the Minister responsible for the environment of its findings on the application at least 5 working days prior to their transmission to the European Chemicals Agency.
"With the exception of the Minister for the Environment, the National Agency transmits to the European Chemicals Agency its product assessment report and, where appropriate, the documents referred to in Article 44 of Regulation (EU) No 528/2012 of the European Parliament and Council of 22 May 2012 or to Article 13 of the Implementing Regulations (EU) No 354/2013 of the Commission of 18 April 2013 already cited.
"Subsection 5
"Instruction of requests for simplified authorization to make available on the market of a biocide product
"Art. R. 522-20.- Within 60 days of the acceptance of a request for simplified authorization to make available on the market of a biocide product under the conditions set out in Article 26 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of May 22, 2012 referred to above and if the product meets the conditions set out in Article 25 of this Regulation, the National Agency shall transmit to the French summary This period shall be extended if any of the suspensive period provided for in Article 26(4) of the above-mentioned Regulation.
"If the National Agency concludes that the conditions set out in section 25 of Regulation (EU) No. 528/2012 are not met, it shall forward to the Minister responsible for the environment any reasoned conclusions as well as an assessment report of this product.
"When the National Agency has not forwarded the documents within the time limits referred to in the first paragraph, it is deemed to have made unfavourable conclusions on the application.
"Subsection 6
"Instruction of requests for authorization to be made available on the market of identical biocide products
"Art. R. 522-21. - Within 15 days from the validation of a request for authorization to make available on the market of a biocide identical to a reference product under the conditions set out in 2 of Article 3 of the Implementing Regulations (EU) n° 414/2013 of the Commission of 6 May 2013 specifying a procedure regarding the authorization of the same biocide products in accordance with the Regulation (EU) n° 528/2012 of the European Parliamentcide
"If the application does not include the information required under section 2 of the Implementing Regulations (EU) No 414/2013 of the Commission dated 6 May 2013 referred to above and does not meet the conditions referred to in the second paragraph of section 3, paragraph 2, of the Regulations, the National Agency shall transmit to the Minister responsible for the Environment the reasoned conclusions presiding the rejection of the application.
"Art. R. 522-22.-Changes made on market authorization decisions relating to reference products, related to risk management measures to mitigate them or when they are made on public health or protection grounds for workers or the environment, apply to products subject to the procedure provided for in R. 522-21 and products with a parallel trade permit.
"Subsection 7
“Instruction of research and development applications
"Art. R. 522-23.-The notification, in accordance with the provisions of 2 of Article 56 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012, already cited, of an experience or test in the national territory that may involve or cause the release in the environment of an unauthorized biocide product is addressed to the National Agency, which keeps up to date a register of such experiments.
"In the event that the conditions of the experiment or the test would result in adverse effects on human health, in particular that of vulnerable groups, or on animal health, or an unacceptable adverse impact on humans, animals or the environment, the National Agency shall transmit reasoned conclusions presuming a ban on experience or testing to the Minister responsible for the environment within 35 days of the notification.
"Art. R. 522-24.-Any experiment or test involving an active substance or a biocide that may have the effects mentioned in 3 of Article 56 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 already cited is subject to a prior authorization of the Minister responsible for the environment that determines, after consultation with the National Agency, the conditions under which such experiments or tests may be conducted.
"A joint order of Ministers responsible for the environment, work and health determines the nature of the information to be provided by the applicant and the procedure for the test or experience.
"Subsection 8
"Instruction of applications for market authorization requiring a comparative assessment of biocide products
"Art. R. 522-25.-A joint decree of Ministers responsible for the environment, health and work, respectively, specifies the elements to be forwarded to the Minister responsible for the environment when the application concerns a biocide product subject to comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 already cited.
"Subsection 9
"Instruction of applications for parallel trade authorization
"Art. R. 522-26.- Within thirty days of receipt of royalties payable under the provisions of Article R. 522-28, the National Agency shall evaluate the application for a parallel trade authorization and, if it considers that the product meets the conditions set out in Article 53 of Regulation (EU) No 528/12 of the European Parliament and of the Council of 22 May 2012 already cited, shall update and
"If it considers that the product does not meet the above-mentioned conditions, the National Agency shall inform the Minister responsible for the environment.
“Section 3
" Provisions common to approvals of biocide active substances and authorizations of biocide products
"Art. R. 522-27.-The information provided for in Article L. 522-2 is as follows:
« 1° New data or information concerning the adverse effects of the active substance or product on humans, particularly vulnerable groups, on animals or on the environment;
« 2° Data indicating that the active substance is likely to induce resistance development;
« 3° New data or information indicating that the biocide product is not sufficiently effective.
"This information is transmitted to the National Agency.
"Art. R. 522-28.-The various applications for approval or renewal of approval of an active biocide substance, authorization to make available on the market of a biocide product or to amend these authorizations as well as a parallel trade authorization are subject to the payment of a royalty to the National Agency.
"It is also subject to the payment of this fee the notifications to be made available on the market of a biocide product referred to in Article 17 6 and Article 27 (1) of Regulation (EU) No 528/2012 of the European Parliament and Council of 22 May 2012 already cited and requests to preserve the confidentiality of certain data referred to in Article 66 of the Regulations.
"These fees must cover all expenses incurred for the conservation, review, operation and expertise of the information provided by the applicant.
"A joint decree of Ministers responsible for the environment and budget, respectively, specifies the amounts and modalities for collecting these royalties.
"Art. R. 522-29.-The National Agency shall prepare a summary of the opinion of the European Chemicals Agency formulated under Article 8 or Article 14(3) of the Regulations.
"The elements of this synthesis, also applicable in other cases where the National Agency is obliged to decide on the opinion of the European Chemicals Agency, are determined by a joint decree of ministers responsible, respectively, for the environment, health and work.
“Section 4
" Provisions applicable to certain biocide products
"Art. R. 522-30.-The conditions of exercise, referred to in Article L. 522-4, of the sale activity and of the activity of professional application of biocide products and processed articles, applicable to certain uses or types of biocide products, are defined by joint decree of ministers responsible, respectively, for work, the environment, health and consumption.
"This includes the training obligations that apply to persons carrying out these activities and the traceability obligations of the use and distribution of these products.
"Art. R. 522-31.-The conditions for the use of certain categories of biocide products provided for in Article L. 522-4 are defined by joint decree of ministers responsible, respectively, for work, the environment, health and consumption.
"This Order sets out the risk management measures applicable to these categories of biocide products, particularly in specific use cases, as well as the administrative conditions of authorization, including their authorization dates. It harmonizes the applicable provisions between, on the one hand, products with an authorization to make available on the market under Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 already cited and, on the other hand, the products put on the market in accordance with the 2 of Article 89 of the Regulations.
“Section 5
« Declaration of Biocide Products
"Art. R. 522-32.-The declaration of biocide products under section L. 522-2 shall be sent electronically to the Minister responsible for the environment prior to the first available on the market in the national territory.
"It includes the following information:
« 1° The name of the person responsible for the first bet on the product market;
« 2° The commercial name of the product;
« 3° The product(s) presented in accordance with Annex V of Regulation (EU) No 528/2012 of the European Parliament and Council of 22 May 2012 already cited;
« 4° The name and quantity or concentration of each active substance contained in the product;
« 5° Classification of the product according to the classification principles set out inArticle L. 1342-2 of the Public Health Code and specified by the decrees taken for its application;
« 6° The Safety Data Sheet set out in Article 31 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, evaluation and authorization of chemical substances, as well as the restrictions applicable to these substances (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Regulation (EEC) No. 793/93 of the Council and Regulation (EC)
« 7° The type of use;
« 8° The authority responsible for the issuance of the marketing authorization as well as the number, date and, where applicable, the requirements or conditions of which the contract is accompanied, if the product is subject to the national transitional provisions referred to in Article L. 522-6;
« 9° Where applicable, the user categories to which the product is intended.
"Art. R. 522-33.-Any modification of one of the data mentioned in 2°, 3° or 4° of Article R. 522-32, as declared, leads to consider the product as new and gives rise to a new declaration.
"A change in one of the data referred to in 1°, 5°, 6°, 7°, 8° or 9° of Article R. 522-32 and any declaration of a product withdrawn from the market voluntarily or as a result of an administrative decision shall result in an update of the original declaration, within one month of each of the modifications in question.
"Art. R. 522-34. -The Minister responsible for the environment issues a registration number to the biocide product within two months of its declaration if it complies with the provisions set out in R. 522-32.
"It makes public the data mentioned in this same article relating to the declared biocide product, with the exception of those under 8°.
"Art. R. 522-35.-In accordance with section L. 522-3, the quantities of biocide products marketed between January 1 and December 31 are reported annually to the Minister responsible for the environment electronically by April 1 of the following year.
“Section 6
Miscellaneous provisions
"Art. R. 522-36.-I.-Where due to new evidence, the Minister responsible for the environment is based on estimating that a biocide presents an immediate or long-term serious risk to human health, in particular that of vulnerable groups, or for animal health or the environment, or that a biocide under the simplified authorization procedure for making available on the market referred to
"With the exception of an emergency, the licensee shall, in advance, make an authorization to make available on the biocide product market in a position to submit its written comments on the interim measure envisaged within 5 working days of the notification of the draft decision. The same is true when the proposed limitation or prohibition of use or availability on the market concerns several biocide products defined by the aforementioned order.
"II.-The Minister for the Environment shall take the same measures when the provision on the market or the use of the biocide product is made in accordance with the national provisions applicable in transitory periods referred to in sections L. 522-6 and L. 522-7 and that this product poses an unacceptable risk to human and animal health or the environment or is insufficiently effective.
"Art. R. 522-37.-I.-The grace periods provided for in Article 52 of Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 referred to above are 180 days for the provision on the market and 180 days for the disposal and use of existing stocks of the products concerned.
"II.-The same deadlines are granted for the flow of authorized products under theArticle 13 of Act No. 2013-619 of 16 July 2013 bringing various provisions for adaptation to European Union law in the field of sustainable development.
"III.-These deadlines may be reduced in cases where the decision to make available on the market or to amend an authorization to make available on the market or an order of the Minister responsible for the environment provides for different time limits.
"Art. R. 522-38.-The label of a biocide product put on the market in accordance with the 2 of Article 89 of Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 mentioned above includes the following:
« 1° Identification of the product and the substances it contains;
« 2° Instructions for use, storage, transportation and disposal.
“In addition, mentions “low-risk biocide product” are prohibited, “non-toxic”, “do not harm health”, “natural”, “ environmentally friendly”, “respectful of animals” or any other similar indication.
"A joint decree of ministers responsible, respectively, for work, the environment, consumption and health defines the modalities for carrying out this label.
"Art. R. 522-39.-I.-The information on biocide products made available on the market, referred to in II of Article L. 522-2, shall be sent electronically to the body designated by decree of ministers responsible for health, work, environment and agriculture, respectively referred to in Article L. 522-2.Article R. 1342-13 of the Public Health Code.
"II.-These information is, for all biocide products, and whatever their danger, those mentioned in theArticle R. 1342-15 of the Public Health Code.
"Art. R. 522-40.-Without prejudice to the provisions applicable to families of biocide products provided for in Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012, the provisions of this chapter may be applied for a single biocide product or for a family of biocide products.
"Art. R. 522-41.-The provision on the market or the use of a biocide product pursuant to 1 of Article 55 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 referred to above is authorized by the Minister responsible for the environment, who, except in case of emergency, consults the National Agency and, where appropriate, the Chemicals and Biocides Commission.
"Art. R. 522-42. -In cases where France is a rapporteur State under amended Regulation (EC) No 1451/2007 concerning the second phase of the ten-year programme of work referred to in Article 16, paragraph 2, of Directive 98/8/ EC of the European Parliament and of the Council concerning the marketing of biocide products, the additional information requested in support of the review of an application for approval of an active biocide substance is transmitted to the National Agency.
“Section 7
“Sanctions
"Art. R. 522-43.-I.-Is punishable by the fine provided for in the 5th class contraventions:
« 1° To make a biocide product available on the market without reporting the information provided in article R. 522-32;
« 2° To make available on the market a biocide product without updating the declaration provided for in I of Article L. 522-2 under the conditions provided for in the first paragraph of Article R. 522-33;
« 3° To make a biocide product available on the market without including the labelling indications provided for in Article 69 of Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 referred to above or by the order provided for in Article R. 522-38;
« 4° To make a treaty article available on the market without including the labelling indications provided for in Article 58 of Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 referred to above;
« 5° To make a biocide product available on the market without having made the notification provided for in 1 of Article 27 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 referred to above, under the conditions provided for in this Article;
« 6° To disseminate an advertisement for a biocide product in ignorance of the provisions of Article 72 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 referred to above;
« 7° To make a product available on the market without providing the necessary information on this product, referred to in Article L. 522-2 II.
"Recidivism is repressed in accordance with the articles 132-11 and 132-15 Criminal code.
"II.-Is punishable by the penalty of fine provided for the contraventions of the third class:
« 1° To make available on the market a biocide product without updating the declaration provided for in I of Article L. 522-2 under the conditions provided for in the second paragraph of Article R. 522-33;
« 2° To make a biocide product available on the market without making the declaration provided for in Article L. 522-3;
« 3° Not to make available the information relating to the biocide treatment of the article treated in accordance with Article 58 of Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 referred to above. »
Chapter III, section 2, is replaced by the following:
“Section 2
“Chemical and Biocide Commission
"Art. D. 523-4.-The Chemicals and Biocides Commission, located with the Minister for the Environment, may be consulted on any draft text relating to the control of chemicals and biocides as well as any matter relating to such products submitted by the Minister for the Environment.
"On request of the Minister for the Environment, the Commission shall issue a notice on the opinions of the European Chemicals Agency referred to in Article 8, 4 or Article 14, paragraph 3, of Regulation (EU) No. 528/2012, of which the National Agency for Health Safety of Food, Environment and Labour, referred to in Regulation (EU) No.Article L. 1313-1 of the Public Health Code, produces a synthesis pursuant to article R. 522-29.
"On request from the Minister for the Environment, the Commission shall issue a notice on the draft decisions relating to applications for authorization, modification or renewal of authorizations to be made available on the biocide market. To this end, it receives, where appropriate, the conclusions of the National Food, Environment and Labour Safety Agency.
"It can address any issue of chemicals and biocides on which it considers it useful to give an opinion.
"Art. D. 523-5.-I.-The commission shall include:
« 1° A President and a Vice-President appointed by the Minister for the Environment;
« 2° A first college of eight members representing the state appointed by decree of the Minister responsible for the environment on the proposal of each of the ministers concerned:
“(a) Two representatives of the Minister for the Environment;
“(b) A representative of the Minister for Health;
"(c) A representative of the minister responsible for consumption;
"(d) A representative of the minister responsible for agriculture;
“e) A representative of the Minister for Industry;
“(f) A representative of the Minister for Research;
“(g) A representative of the Minister of Labour;
« 3° A second college composed of four representatives of professional organizations in the chemical and biocide sector, distribution and users;
« 4° A third college composed of two representatives of associations, selected from the approved environmental associations at the national level in accordance with the provisions of Article L. 141-1 of the Environmental Codeconsumer associations approved at the national level in accordance with provisions of Article L. 411-1 of the Consumer Code, or associations with activities in the field of health quality and care for registered patients at the national level in accordance with provisions of Article L. 1114-1 of the Public Health Code ;
« 5° A fourth college composed of two representatives of employees, from the most representative trade union organizations at the national level;
« 6° A fifth college composed of representatives of the following expert bodies:
“(a) The Director General of the National Health Safety Agency for Food, Environment and Labour;
“(b) The director of the organization mentioned to theArticle L. 4411-4 of the Labour Code ;
"(c) The Director General of the National Institute of Industrial Environment and Risk;
"(d) The Director General of the National Drug and Health Products Safety Agency;
“e) The Director General of the Health Watch Institute;
“(f) A representative of the bodies responsible for toxicovigilance referred to inArticle L. 1341-1 of the Public Health Code.
"II.-The members listed in 3°, 4° and 5° of I are appointed by order of the Minister responsible for the environment.
"The representative of the organization referred to in f 6° of I shall be appointed by order of the Minister for the Environment on the proposal of the Minister for Health.
"These members and their alternates, as well as the President and Vice-President, are appointed for a term of five years.
"III-In the event of the failure or absence of its president, the commission is chaired by the Vice-Chair.
"Art. D. 523-6.-The secretariat of the commission is provided by the Minister for the Environment or his representative. Les membres du secrétariat assistent aux réunions de la commission.
"The members of the commission, as well as any person consulted by it, are obliged to respect the confidentiality of the information they are required to know.
"In each vote, in the event of the equal sharing of votes, the President's voice or, in his absence, the Vice-President shall prevail.
"The Commission adopts its rules of procedure that are subject to the approval of the Minister responsible for the environment.
"Art. D. 523-7.-The members of the commission shall exercise their functions free of charge. They may, however, be awarded compensation for the actual travel and living expenses incurred at meetings, under the conditions fixed by the Decree No. 2006-781 of 3 July 2006 setting out the conditions and procedures for the payment of costs caused by the temporary movement of State civilian personnel. »
I.-At the 8th of R. 521-2-14, the words: "of 3 of Article 41" are replaced by the words: "of 4 of Article 41 and within the time limits set out in 4 of Article 41".
II.-Section 2 of chapter I is amended as follows:
1° The word "preparations" is replaced by the word "mixes" in the titles and articles of this section;
2° The words: "dangerous preparations" are replaced by the words "dangerous mixtures" in the titles and articles of this section;
3° At subsection 2, paragraphs 2 to 4 and paragraphs 6 to 16 are repealed. Paragraph 5 becomes paragraph 2;
4° Subsections 3 and 4 are repealed.
The Public Health Code is amended to read:
1° In article R. 1333-4, the words: "radionuclide addition" are deleted;
2° The 3rd of section R. 1333-18 is replaced by the following:
« 3° All or part of the activities referred to in 1° of I of Article R. 1333-17 for consumer goods and construction products that benefit from an exemption granted under Article R. 1333-4, where such exemption provides such an exemption for that or those activities; » ;
3° Sub-section 1 of chapter IV, section 3, title I of Book I of Part III (regulatory portion) is repealed.
Decree No. 2009-1685 of 30 December 2009 referred to above is amended as follows:
1° In section 1 and sections 6 and 9, the words: "I of section 9 of the above-mentioned Act of August 1, 2008" are replaced by the words: " I of Article 13 of Act No. 2013-619 of 16 July 2013 bringing various provisions for adaptation to European Union law in the field of sustainable development";
2° In Article 1, II, the words: "a change in the composition of the product" are replaced by the words: "a change in the composition of active substances or non-active substances necessary for the effectiveness of the biocide product" and the words: ", other than any change resulting from a regulatory provision" are added after the words: "a change in the classification, packaging or labelling of the product";
3° In the third of Article 1, the words: "IV of Article 9 of the above-mentioned Act of August 1, 2008" are replaced by the words: "IV of Article 13 of the Act of July 16, 2013 already cited";
4° In Article 3 I, the words "three months" are replaced by the words "six months" and the words "six months" are replaced by the words "nine months";
5° In the third of section 3, the words: "2 of the second of section 9 of the above-mentioned Act of 1 August 2008" are replaced by the words: "2 of the second of section 13 of the Act of 16 July 2013 already cited";
6° In section 5, the words: "the entry into force of the authorization provided by the provisions of Article L. 522-4 of the Environmental Code are replaced by the words: "approval of an authorization in accordance with the provisions of Regulation (EU) No. 528/2012 of the European Parliament and of the modified Council of 22 May 2012 concerning the availability on the market and use of biocide products";
7° In Article 7, the words: "1 of the II of Article 9 of the above-mentioned Act of August 1, 2008" are replaced by the words: "1 of the II of Article 13 of the Act of July 16, 2013 already cited";
8° Section 8 is repealed;
9° In Article 10, the words: "in Article 8" are replaced by the words: "in Article 8"Article R. 522-30 of the Environmental Code which uses the products mentioned in I of Article 13 of the Act of 16 July 2013 already cited."
Decree No. 97-1204 of 19 December 1997 referred to above is amended as follows:
1° In the table in I of Title I of the Schedule is added in the book category V, after the line: "Exemption to Regulation (EC) No 1907/2006 concerning National Defence", a line thus written:
| Exemptions to Regulation (EU) No 528/2012 concerning National Defence Joint decision of the Minister of Defence and Minister for the Environment | Article R. 522-2 |
2° In the table in Part II of Title I of the Schedule, lines 6 to 14 of Book V are replaced by the following:
| Interim release of a biocide product on the market containing a new active biocide substance under review | Article R. 522-4 |
| National authorization to make available on the market and to renew national authorization for a biocide product | Articles R. 522-6 and R. 522-7 |
| National authorization to be made available on the market by mutual recognition (simultaneous or sequential) | Articles R. 522-9, R. 522-10 and R. 522-11 |
| Amendment of national authorization to make available on the market of a biocide product (administrative amendment) | Articles R. 522-12 |
| Amendment of national authorization to make available on the market of a biocide product (minimum modification) | Articles R. 522-13 to R. 522-15 |
| Amendment of national authorization to make available on the market of a biocide product (major modification) | Articles R. 522-16 to R. 522-18 |
| Simplified market availability of a biocide product | Article R. 522-20 |
| Authorization of availability on the market of identical biocide products | Article R. 522-21 |
| Authorization of experiments or tests on biocide products or biocide active substances | Articles R. 522-23 and R. 522-24 |
| Parallel trade authorization | Article R. 522-26 |
Decree No. 2011-578 of 25 May 2011 on the commission of chemicals and biocides is repealed.
I. - The provisions of Article 3 shall apply on the date of entry into force of the order in Part II of Article D. 523-5 of the Environmental Code in its drafting of that Article.
II. - The provisions of 8th of Article 6 apply on the date of entry into force of the order provided for in the orderArticle R. 522-30 of the Environmental Code in its writing from article 2 of this decree.
The Minister of Ecology, Sustainable Development and Energy, the Minister of Justice, the Minister of Finance and Public Accounts, the Minister of Defence, the Minister of Social Affairs, Health and Women's Rights, the Minister of Labour, Employment, Vocational Training and Social Dialogue, and the Minister of Economy, Industry and Digital Affairs, are responsible, each with respect to the official decree, for the publication of this Journal
Done on 13 October 2014.
Manuel Valls
By the Prime Minister:
Minister of Ecology, Sustainable Development and Energy,
Royal
The Seal Guard, Minister of Justice,
Christiane Taubira
Minister of Finance and Public Accounts,
Michel Sapin
Minister of Defence,
Jean-Yves Le Drian
Minister of Social Affairs, Health and Women ' s Rights,
Marisol Touraine
The Minister of Labour, Employment, Vocational Training and Social Dialogue,
François Rebsamen
Minister of Economy, Industry and Digital,
Emmanuel Macron
