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Decree No. 2004-187 Of 26 February 2004 On The Transposition Of Directive 98/8/ec Of The European Parliament And Of The Council Of 16 February 1998 Concerning The Placing On The Market Of Biocidal Products

Original Language Title: Décret n° 2004-187 du 26 février 2004 portant transposition de la directive 98/8/CE du Parlement européen et du Conseil du 16 février 1998 concernant la mise sur le marché des produits biocides

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Application Texts

Summary

The I of art. R. 231-52-2 of the Labour Code (art. 1 of Order-in-Council 92-1261) is completed by an 8 ° (written).
Amendment of Art. 11 and 11-1 of Order 73-138.
Amendment of Art. 5 and 6 of Decree 2001-275 and insertion of an art. 3-1 (written) Order in Council.
Amendment of Art. 1 of Order 67-743.
Amendment of Order 97-1204 in accordance with the provisions of this
.

Keywords

ECOLOGY , SUSTAINABLE DEVELOPMENT , CHEMICAL PRODUCT , BIOCIDAL PRODUCT , TURN ON , HAZARDOUS SUBSTANCE , PESTICIDE FOR NON-AGRICULTURAL USE , ACTIVE SUBSTANCE , MUTUAL RECOGNITION , AUTHORIZATION , REGISTERING , CLASSIFICATION , PACKAGING , TAGGING , CONTROLE , APPLICATION OF REGULATION , TRANSPOSITION OF DIRECTIVE THIS , EUROPEAN HARMONISATION


JORF No. 50 of 28 February 2004 Page 4095
Text No. 29



Decree n ° 2004-187 of 26 February 2004 transposing Directive 98 /8/EC of the European Parliament and of the Council of 16 February 1998 on the placing on the market of biocidal products

NOR: DEVX0300188D ELI: https://www.legifrance.gouv.fr/eli/decret/2004/2/26/DEVX0300188D/jo/texte
Alias: https://www.legifrance.gouv.fr/eli/decret/2004/2/26/2004-187/jo/texte


President of the Republic,
On the report of the Prime Minister and the Minister of Ecology and Sustainable Development,
In view of the Regulation (EC) No 1896/2000 of the Commission of 7 September 2000 concerning the first phase of the programme referred to in Article 16 (2) of Directive 98 /8/EC of the European Parliament and of the Council on biocidal products;
In view of the EC Regulation No 2032/2003 of the Commission of 4 November 2003 concerning the second phase of the ten-year work programme referred to in Article 16 (2) of Directive 98 /8/EC of the European Parliament and of the Council on the placing on the market of products Biocides and amending Regulation (EC) No 1896/2000;
Having regard to Directive 98 /8/EC of the European Parliament and of the Council of 16 February 1998 on the placing on the market of biocidal products;
In view of Directive 2000 /21/EC of the Commission of 25 April 2000 concerning the list of Community acts referred to in the fifth indent of Article 13 (1) of Council Directive 67 /548/EEC;
In view of the environmental code, in particular Articles L. 521-1, L. 521-11 and L. 522-1 to L. 522-18;
Given the Labour Code, including articles L. 231-6, L. 231-7, R. 231-51, R. 231-52-2, R. 231-52-7, R. 231-52-16;
In view of the code of public health, including its articles L. 1323-1, L. 1335-3-1, L. 3114-1, L. 5132-2, L. 5132-3, L. 5132-4, L. 5311-1, R. 1335-3-1 to 28, R. 1342-2, R. 1342-13, and R. 1342-15 to R. 1342-19;
In view of Act No. 2000-321 of 12 April 2000 on the rights of citizens in their relations with administrations, in particular Article 21;
Vu le Decree No. 67-743 of 30 August 1967 concerning the regulation of public administration relating to the conditions to be fulfilled by the procedures, products and apparatus for compulsory disinfection;
In view of Decree No. 73-138 of 12 February 1973 Application of the Act of 1 August 1905 on fraud and falsifications in respect of processes and products used for the cleaning of materials and articles intended to come into contact with foodstuffs, products and beverages for Food for man and animals;
In light of Decree No. 85-217 of 13 February 1985 on the control of chemicals;
In view of Decree No. 97-34 of 15 January 1997 concerning the deconcentration of administrative decisions Individual;
Having regard to Decree No. 97-1204 of 19 December 1997 adopted for the application to the Minister responsible for the environment of the 1 ° of Article 2 of Decree No. 97-34 of 15 January 1997 concerning the deconcentration of administrative decisions Individual;
In view of Decree No. 2001-725 of 31 July 2001 on technological auxiliaries that may be employed in the manufacture of foodstuffs intended for human consumption;
In the opinion of the Higher Council for the Prevention of Occupational hazards as of April 19, 2002;
In view of the opinion of the National Commission for Occupational Health and Safety in Agriculture dated April 29, 2002;
The Council of State (Public Works Section) heard;
Council of the Ministers heard,
Describes:

Item 1
The placing on the market of biocidal active substances and biocidal products defined in Chapter II of Title II of Book V of the Environment Code shall be subject to the provisions of this Decree.

  • TITLE I: CONTROL OF ACTIVE BIOCIDES SUBSTANCES Item 2


    I. -Without prejudice to the provisions of Article L. 522-2 of Code of the environment, only may be placed on the market and used in biocidal products which are biocidal active substances listed, in accordance with the procedure laid down in Articles 3 and 4 of this Decree, on three Community lists appearing In Annexes I, IA and IB of the abovementioned Directive of 16 February 1998. These lists, named lists I, IA and IB, are published by an order of the Minister responsible for the environment, which sets the deadline for the validity of the registration of each
    . -The AI list contains biocidal active substances which can be included in low risk biocidal products for human beings, animals and the environment, under the conditions laid down for their use. No substance may be included on this list if it is classified, pursuant to Articles R. 231-51 of the Labour Code, L. 5132-3 and R. 1342-2 of the Code of Public Health in the category of carcinogenic, mutagenic and toxic substances For reproduction, sensitizing or bioaccumulative and not easily degradable. Where appropriate, the concentration levels between which the substance can be used are listed.
    III. -The list IB contains the basic substances which are mainly used in products other than pesticides, either directly or in a product formed by the substance and a simple diluent, and which are not directly marketed For biocidal use.
    IV. -List I contains substances not on the IA list or on the IB list for types of products containing them.

    Article 3


    I. -If it is not addressed to the competent authorities of another Member State of the European Community, the application for provisional authorisation for placing on the market provided for in Article L. 522-2 of the Environment Code for a Biocidal active substance which is not, as such, a biocidal product, the registration of a biocidal active substance on the Community lists referred to in Article 2, the renewal or amendment of that registration, shall be addressed to the Minister responsible for the environment, who may proceed with his or her appraisal or ask another Member State of the European Community to do
    . -This application, drafted in French, is accompanied by a dossier relating to the biocidal active substance and a file relating to at least one biocidal product containing it. The composition of the dossiers is defined by the joint decree of the ministers responsible for labour, agriculture, the environment, health, consumption and industry. In particular, they shall include a detailed and complete description of the studies carried out and the methods used, or a bibliographic reference to such methods.
    In the case of an application for provisional authorisation for placing a substance on the market Active biocidal, the records are accompanied by a statement that the active substance is intended to be incorporated into a biocidal product.

    Item 4


    I. -Within three months of receipt of the request, the Minister responsible for the environment, after receiving the opinion of the French Environmental Health Agency, shall make known to the applicant whether the Information contained in the files is sufficient to enable the assessment of the effects, risks and properties of the substance. This period may be extended, without exceeding six months, if consultations have been undertaken on this matter with one or more other Member States of the European Community.
    In exceptional circumstances, the Minister responsible for The environment may set a new deadline for the submission of information which, for duly justified reasons, the applicant was unable to provide on time. Within three months of the communication of the new deadline, the applicant shall provide the Minister responsible for the environment with proof that work to provide the missing information has been ordered. If the Minister considers this evidence to be sufficient, the Minister responsible for the environment shall assess the record in accordance with the provisions of this
    . -If the dossier is considered sufficient, the Minister responsible for the environment shall invite the French Environmental Health Agency to carry out its assessment and authorise the applicant to submit a summary to the European Commission and to the Other European Community member states. Such authorisation, or a similar authorisation issued by the competent authorities of another Member State of the European Community, shall entail the provisional authorisation for placing on the market provided for in Article L. 522-2 of the Code of Environment.
    III. -The French Environmental Health Safety Agency draws up an evaluation report on the basis of the elements provided, in their respective fields of competence, in particular by the National Institute of Industrial Environment and Risk, a Approved body by the Ministers responsible for health, labour, agriculture and the environment, by the French Food Safety Agency, or the French Health Product Safety Agency.
    The Order Section 3 sets out the conditions under which this assessment is conducted.
    IV. -The Minister may request further information during the assessment procedure, or at the request of the Committee on Chemicals and Biocides. In this case, the twelve-month period provided for in VI below shall be suspended from the date of receipt by the applicant of the request for further information up to the date on which an acknowledgement of receipt of such information is received by the applicant. Where such information has been deemed sufficient by the Minister responsible for the environment after notice, if any, of the French Environmental Health Safety Agency and no later than three months after the expiry of the Receipt of the requested information.
    V. The Minister responsible for the environment takes the opinion of the Committee on Chemicals and Biocides of the application and the evaluation report of the
    . -The Minister responsible for the environment shall forward to the European Commission, to the other Member States and to the applicant within twelve months of the date on which he has informed the European Commission of the sufficiency of the file, a proposal Registration, renewal of registration or refusal to register the active substance on one of the Community lists provided for in Article 2, together with the opinion of the Committee on Chemicals and Biocides and the report File evaluation. The Minister may propose that the renewal of a registration be made only on a provisional basis, to allow for the collection of additional information provided for in the IV and to conduct a review.

    Article 5


    The entry of a biocidal active substance on one of the Community lists referred to in Article 2 allows its placing on the market only for its purpose Use in one or more of the categories of products listed in the Annex and whose order under Article 3 specifies, where appropriate, the description, for which relevant data have been provided in accordance with Article 9 of the
    This entry is, if necessary, subject to:
    1 ° A of the following requirements:
    (a) At the minimum purity level of the biocidal active substance;
    (b) The maximum content of certain impurities and the nature of the These;
    (c) To the type of product in which it can be used;
    (d) In the mode and domain of use;
    e) A designation of user categories;
    (f) Other special conditions resulting from the assessment of Information available;
    2 ° Has the following:
    a) An acceptable level of exposure for man;
    b) If applicable, a tolerable or tolerable daily intake for humans and one or more maximum limits Residues. For the purposes of these provisions, " Residues " One or more of the substances contained in a biocidal product, as well as the metabolites and products resulting from the degradation or reaction of the same substances Results from the use of this biocidal product;
    c) The evolution and behaviour of the substance or product in the environment, as well as its impact on organisms that they are not intended to destroy, repel or render Harmless.
    The Minister responsible for the environment may, under the conditions laid down in III, IV, V and VI of Article 4, propose to the European Commission that the conditions for the registration of a biocidal active substance be revised Article, if it considers that the conditions laid down in Article L. 522-4 of the Environmental Code and of Article 2 of this Decree are no longer fulfilled.

    Article 6


    I. -If, following the assessment referred to in Article 4, it appears that a biocidal active substance may be proposed for inclusion on the Community lists Referred to in Article 2, or if that substance is already listed on those lists, a proposal for refusal or withdrawal of registration may nevertheless be formulated in accordance with the Community comparative assessment procedure provided for in Article 2. L. 522-3 of the Environment Code if the following conditions are met:
    -if the assessment of the biocidal active substance shows that, under the intended conditions of its use in authorised biocidal products, doubts remain Serious on the risks presented by this substance for health or the environment;
    -if there is another biocidal active substance on the Community lists for the same type of product which, taking into account the state of the Scientific or technical knowledge and experience acquired, and under the conditions laid down in its use in authorised biocidal products, has less health or environmental risks and can be used with Effects on the organisms concerned, without any significant economic or practical disadvantages for the user.
    The decision to propose the refusal or withdrawal of the registration of a biocidal active substance for the reasons stated above is Taking into account the need to maintain a sufficient chemical diversity of biocidal active substances available to reduce the risk of resistance of the affected
    . -Where the Minister responsible for the environment intends to propose a refusal or withdrawal of the registration of a biocidal active substance on the Community lists for the reasons provided for in the I, he shall implement, after the opinion of the Committee on Products Chemical and biocides, where appropriate on a proposal from the French Environmental Health Safety Agency, and in accordance with the provisions of III, IV and V of Article 4, a comparative assessment of one or more active substances Substitution biocides, in order to determine whether this substance meets the conditions set out in the above.
    The Minister responsible for the environment shall forward this assessment to the European Commission, to the other Member States of the Community The applicant for the registration of the active substance whose refusal or withdrawal is envisaged.

    Article 7


    The assessment, with a view to listing on the lists referred to in Article 2 of this Decree, of active substances on the Community list of substances on the market as of 14 May 2000, published in Annex I to the Regulation of 4 November 2003 referred to above, shall be conducted in accordance with the procedure laid down in Article 4 of this Decree

  • TITLE II CONTROL OF THE PRODUCT MARKET BIOCIDES Article 8


    The marketing authorisation for a biocidal product provided for in Article L. 522-4 of the Environment Code shall be issued by the Minister responsible for The environment, after evaluation by the French Environmental Health Safety Agency and opinion of the Committee on Chemicals and Biocides. This authorisation shall be granted in full right where the product consists solely of a substance listed in the IB list referred to in Article 2, together with a diluent.

    Item 9


    I. -The request for authorisation, drawn up in French, shall be addressed to the Minister responsible for the environment by the person responsible for the first placing on the market, or By an agent. Every applicant must have a permanent office in a Member State of the European Community. The application includes:
    (a) A file relating to the biocidal product or a document called " Letter of access ", by which the owner or owners of relevant data protected in accordance with Article 16 of this Decree shall authorise the use of Such data by the Minister responsible for the environment in the context of the authorisation procedure for placing a biocidal product on the market;
    (b) For each biocidal active substance contained in the biocidal product, a letter of access or File.
    The contents of the above files are defined by the Section 3 Order. This includes a detailed and complete description of the studies carried out and the methods used, or a bibliographic reference to these methods.
    II. -Within three months of receipt of the request, the Minister responsible for the environment, after receiving the opinion of the French Environmental Health Safety Agency, shall inform the applicant if the information contained in the Files are sufficient to allow an assessment of the effects, risks, and properties of the product.
    III. -If the Minister considers the dossier sufficient, the Minister responsible for the environment shall ask the French Environmental Health Safety Agency to carry out its assessment under the conditions laid down in III of Article 4 above. At the request of the Commission or the competent authorities of another Member State of the European Community, it shall invite the applicant to submit the files referred to in I above.
    IV. -The Minister responsible for the environment shall make a decision on the application within twelve months of the date on which it has informed the applicant of the sufficiency of the file.
    However, the Minister may, if he thinks fit, request Additional information. In that case, the period provided for in the preceding paragraph shall be suspended from the date of receipt by the applicant of the request for further information up to the date on which an acknowledgement of receipt of such information is issued to the applicant when They were deemed sufficient by the Minister responsible for the environment, and not later than three months after receipt of the information requested.
    V.-For biocidal products exclusively for professional use, the The granting of the marketing authorisation shall be subject to the prior agreement of the Minister responsible for labour. This agreement shall be deemed to have been granted if the Minister responsible for the work has not communicated to the Minister responsible for the environment his opposition to the granting of the authorisation within 14 days from the date on which he received the notice of the Committee on Chemicals and Biocides and, in any event, before the expiry of the deadline for the Minister responsible for the environment to take this
    . -Authorisation to market a biocidal product may be subject to employment limitations if there are other physical or biological methods of neutralising or disposing of the organisms concerned. It may be limited to parts of the territory.
    VII. -The authorisation shall be granted for a maximum period of ten years from the date of registration or re-registration of the active substance contained in the biocidal product, for the category of product to which it belongs, on lists I or IA referred to in Article 2 and, in any case, without exceeding the deadline set by those
    . -At the request of the holder of the authorisation, or where it considers it necessary, taking into account the development of scientific and technical knowledge and in order to protect health and the environment, the Minister responsible for the environment may, after notice Of the French Environmental Health Security Agency, modify the conditions of use defined in the marketing authorisation for a biocidal product.

    Article 10


    I. -Low-risk biocidal products referred to in Article L. 522-6 of the Environment Code shall contain only biocidal active substances listed on the IA list And no substance of concern. For the purposes of this Decree, " Concern substance " Any substance, other than the biocidal active substance, inherently capable of causing an adverse effect on humans, animals or the environment, which is Contained or produced in a biocidal product at a concentration sufficient to cause such an effect, and which, in the case of entering the biocidal product in which it is contained within the scope of Articles R. 231-51 of the Labour Code, L. 5132-4 and R. 1342-2 of the Public Health Code, or other grounds of concern.
    The products referred to in the first paragraph are the subject of an application for a marketing authorization addressed to the Minister responsible for The environment and accompanied by a simplified dossier, the content of which is laid down in the order laid down in Article 3 of Article
    . -The Minister responsible for the environment shall notify his decision within 60 days of the date on which he informed the applicant of the sufficiency of the file under the conditions laid down in II of Article 9. This period shall be suspended if the Minister responsible for the environment requests additional information under the conditions laid down in the second paragraph of Article 9.

    Article 11


    When issuing marketing authorization for a biocidal product, the Minister responsible for the environment may establish " Framework formulation " That defines the Characteristics of the group to which this product belongs, for the same type of uses and users. He communicates this " Framework formulation " The applicant, with a view to its subsequent use, by itself or by any person to whom it has issued a letter of access, for the application for authorisation to market new products Biocides corresponding to this " Framework ".
    Biocidal products in this group shall contain the same biocidal active substances and the variations in their composition shall not affect the level of risk or The efficiency which characterises this group of products.
    The variations consisting of a decrease in the percentage of the biocidal active substance, in a change in the percentage composition of one or more substances, are tolerated. Active, or in the replacement of one or more pigments, dyes or perfumes by others with the same level of risk or a lower risk, and does not reduce the efficiency.
    Product market authorization Biocidal corresponding to a " Framework formulation " Shall be granted by the Minister responsible for the environment, in the light of a simplified file whose composition is laid down in the order laid down in Article 3 of Article 3, to the holder of that ' Framework formulation " Or to Any other applicant who has a letter of access to this " Framework ', within 60 days from the date on which the Minister informed the applicant of the sufficiency of the file under the conditions laid down in II of Article 9. This period shall be suspended if the Minister requests further information under the conditions laid down in the second paragraph of Article 9.

    Article 12


    I. -Where the placing on the market of a biocidal product has already been authorised in another Member State of the European Community in accordance with the abovementioned Directive of 16 February 1998 and when the active substance (s) Biocides entered in its composition are on the lists I or IA referred to in Article 2, the application for authorisation to market shall be accompanied by a copy, certified by the applicant, of the first authorisation issued and A simplified file whose contents are defined by the order under Article 3.
    II. -For biocidal products containing one or more substances listed on list I, the Minister responsible for the environment shall notify the applicant within one hundred and twenty days from the date of receipt of the application. This period shall be suspended if the Minister requests further information under the conditions laid down in the second paragraph of Article 9.
    The authorisation may be granted only if the substance contained in the product complies with the requirements With its listing on list I.
    III. -For the low-risk biocidal products referred to in Article L. 522-3 of the Environment Code and already authorised in another Member State of the European Community in accordance with the Directive of 16 February 1998 referred to above, the period referred to in I is sixty days. Authorisation may be granted only if the biocidal active substance contained in the product complies with the requirements for listing on the IA
    . -Authorisation for the placing on the market of a biocidal product already authorised in another Member State of the European Community may be subject to the modification of some of the indications provided for in the interministerial order made in application Section 20 of this Order in any of the following circumstances:
    a) If the prescribed species is not present in a harmful quantity on the national territory;
    (b) If the prescribed organism exhibits unacceptable tolerance or resistance to the Biocidal product;
    (c) If the relevant circumstances of use, such as the climate or the period of reproduction of the species concerned, differ significantly from those in the Member State in which the product Biocide has been authorized for the first time and, therefore, an unaltered authorization may present unacceptable risks to humans or the environment.
    V. The Minister responsible for the environment may refuse, by reasoned decision, the Mutual recognition of authorisations granted for the types of products 15, 17 and 23 referred to in the Annex to this Decree.

    Article 13


    I. -The provisional authorisations for placing on the market provided for in Article L. 522-7 of the Environment Code shall be issued by the Minister responsible for the environment for a maximum period of three years. They may be extended for a period of one year if the assessment of the dossiers submitted for listing on the lists I or IA referred to in Article 2 of a biocidal active substance contained in the product is not completed
    Authorisations are issued only if the following conditions are met:
    -if the Minister responsible for the environment considers, after evaluation of the files under the conditions laid down in Articles 3 and 4 of this Decree, that the active substance The biocide contained in the product meets the requirements for entry on list I referred to in Article 2 and that the product meets the requirements of Article L. 522-4 of the Environment Code;
    -if no Member State of the Community European Union does not dispute the sufficiency of the files, on the basis of the summary transmitted pursuant to Article
    . -The provisional authorisations for placing on the market provided for in 2 ° of the I of Article L. 522-7 of the Environment Code shall be granted, to the conditions of use which they determine, for a maximum period of 120 days by the Minister responsible for The environment, which, except in cases of emergency, first seeks the opinion of the French Environmental Health Agency and the Committee on Chemicals and Biocides

  • TITLE III: MISCELLANEOUS Article 14


    No person shall sell a listed biocidal product to the non-professional public under the provisions of R. 231-51 of the Labour Code and L. 5132-4 of the Public Health Code, in the categories of toxic, very toxic, proven carcinogens, proven or toxic for reproduction.

    Article 15


    The limitation or prohibition measures provided for in III of Article L. 522-9 and II of Article L. 522-18 of the Environment Code are taken by The Minister responsible for the environment.

    Article 16


    I. -The Minister responsible for the environment cannot use the Of another applicant, unless the applicant has a letter of access, the information provided to him in connection with an earlier application for a marketing authorisation or an entry on the lists provided for in Article 2:
    (a) For A biocidal active substance not on the market as of 14 May 2000, for 15 years from the date of the first entry in Annex I or IA of the abovementioned Directive of 16 February 1998;
    (b) For a biocidal product containing A biocidal active substance not on the market as of 14 May 2000, for a period of ten years from the date of the first authorisation in a Member State of the European Community;
    (c) For a biocidal active substance Already on the market on 14 May 2000 or for a biocidal product containing such a substance:
    -for ten years from 14 May 2000 in respect of all the information transmitted pursuant to Chapter II of Title II of the book V of the Environment Code;
    -for ten years from the date of the decision to register a biocidal active substance or an additional type of product on Annex I or IA of Directive 98 /8/EEC referred to above, for information Transmitted for the first time in support of the application for first entry in Annex I or IA either of the active substance or of an additional type of product for that active substance;
    (d) For five years from:
    -of the date of The decision with regard to the information transmitted for the first time with a view to amending the conditions for the registration of a biocidal active substance or for the maintenance of registration in Annexes I or IA to the Directive of 16 February 1998 ;
    -from the date of receipt of the information transmitted for the first time for the modification of the conditions for the authorization of a biocidal product or the maintenance of the registration of the active substance in Annexes I or IA of the Directive.
    If this five-year period expires before the end of the a, b, and c period, it is extended to the end of this period.

    Article 17


    The applicant for the marketing authorisation of a biocidal product may refer to the information already provided by a previous applicant, if it demonstrates that the product being The subject-matter of its application is similar to a product already authorized under sections 8, 10 and 11 of this Order and its active substances, including their degree of purity and the nature of their impurities, are identical to those of the product Already authorized.

    Item 18


    Any person who intends to conduct a vertebrate test for an authorization to Placing on the market of a biocidal product must first ask the Minister of the Environment if the biocidal product for which the application for authorisation is being considered is similar to a biocidal product already authorised.
    The applicant produces the Documents demonstrating that it intends to introduce the application for its own account and that it is in a position to provide the other information required under Article 9.
    If marketing authorisations for Similar products have already been issued, the Minister responsible for the environment shall communicate to the applicant the name and address of the holders of such authorisations and shall communicate to the applicant the name and address of the applicant
    Marketing authorisations and the applicant are seeking an agreement on a shared use of information to avoid repetition of tests using vertebrates. If this agreement cannot be reached, the applicant shall inform the Minister responsible for the environment before repeating the tests.

    Article 19


    The information provided for in Article L. 522-10 of the Environment Code concerns:
    -the new knowledge available on the effects of the biocidal active substance or biocidal product on humans or the environment;
    -the Changes in the origin or composition of the biocidal active substance;
    -changes in the composition of the biocidal product;
    -the development of a resistance;
    -the nature of packaging;
    -all Other changes such as the identity, address and legal status of the holder of the authorization.

    Item 20


    I. - Without prejudice to the provisions of Articles R. 231-51 of the Labour Code, L. 5132-4 and R. 1342-2 of the Code of Public Health, or where appropriate other regulatory provisions relating to labelling, the order provided for in Article 3 shall determine Indications that must appear on the label of a biocidal product.
    II. -Without prejudice to the provisions of Article R. 231-53 of the Labour Code, the person responsible for placing a biocidal product on the market shall make available to non-professional users an information document whose contents are defined by A joint decree of the ministers responsible for labour, agriculture, the environment, health, consumption and industry.

    Article 21


    Any advertising for a biocidal product is accompanied by the following warnings: " Use biocides with caution. Before you use it, read the label and product information. " These warnings are clearly distinguishable from the overall advertising.
    Advertisers may replace, in the warnings referred to in the preceding paragraph, the word: " Biocides " By a precise description of the type of product that is The purpose of the advertisement.
    Advertising for a biocidal product may not, under any circumstances, refer to: Low-risk biocidal product "," Non-toxic "," Does not harm health " Or any other similar indication. The reference to a biocidal product must not be misleading as to the risks of the product to humans or the environment.

    Article 22


    The placing on the market of a biocidal product or biocidal active substance with a derogation under Article L. 522-7 of the Environment Code is permitted only in the following cases:
    (a) In the The framework for a scientific research and development action defined in Article R. 231-52-4 of the Labour Code, if the persons responsible for this action keep written statements detailing the identity of the biocidal product or The biocidal active substance, the labelling particulars, the quantities supplied and the names and addresses of the persons who have received the product or the substance, and establish a file containing all available data on the effects Potential for human or animal health or environmental impact. On its request, this information shall be communicated to the Minister responsible for the environment;
    b) In the context of a research and production development action defined at 2 ° V of Article R. 231-52-4 of the Labour Code, if the information Prior to the placing on the market of the biocidal product or the biocidal active substance, to the Minister responsible for the environment and the competent authority of another Member State if the experiment or test is to be carried out On the territory of the latter.
    However, placing on the market for a trial which may result in the release into the environment of an unauthorized biocidal product or of a biocidal active substance intended exclusively for use in a Biocidal product shall be permitted only if the Minister responsible for the environment has previously authorised the completion of this test, limiting the quantities to be used and the areas to be treated, or subject to other conditions justified by the Protection of the environment and human and animal health.

    Article 23


    Any experiment or test involving a substance Biocidal active or a biocidal product, including when that biocidal product or product has already been placed on the market in another Member State, is subject to authorisation by the Minister responsible for the environment, who shall determine the conditions In which such experiments or tests may be carried out.
    The order provided for in Article 3 shall determine the nature of the information to be provided by the applicant, as well as the procedures for the conduct of the experiment.

    Article 24


    The authorized organization under article L. 522-13 of the environment code to receive product information Biocides placed on the market is designated by a joint decree of the ministers responsible for labour, agriculture, environment and health. This information is, for all biocidal products, and regardless of their dangerousness, the information provided in Articles R. 1342-13 and R. 1342-15 to R. 1342-19 of the Public Health Code and Articles R. 231-52-7 and R. 231-52-16 of the Code of the Job.
    They can only be used to respond to medical requests for preventive or curative measures, especially in emergencies.

    Article 25


    The person responsible for placing a biocidal active substance on the market, the applicant for the registration of a biocidal active substance on the Community lists referred to in Article 2 of this Decree and the applicant for authorisation to place a biocidal product on the market shall pay to the French Environmental Health Safety Agency remuneration intended to cover the expenditure incurred in respect of Retention, review, exploitation and expertise of the information provided.
    A joint Order of the Ministers responsible for the environment, health and budget sets the tariff and the manner in which the remuneration is collected.

  • TITLE IV: CHEMICALS AND BIOCIDES COMMISSION Article 26


    The Minister responsible for The Committee on Chemicals and Biocides.
    The Committee may be consulted on any draft text relating to the control of chemicals and biocides, as well as any questions relating to These products shall be submitted by the Minister responsible for the environment.
    The Committee shall deliver an opinion on the applications for registration of biocidal active substances on the Community lists referred to in Article 2 and on applications Marketing authorisation for biocidal products. For this purpose, it shall receive the evaluation reports provided for in Article 4 and III of Article 9.
    It may refer to any question and file relating to the chemicals and biocides on which it considers it useful. To give an opinion.
    Its notices can be made public.

    Item 27


    I. -The Commission shall comprise:
    1 ° A President and a Vice-President, appointed by the Minister responsible for the Environment;
    2 ° Two representatives of the Minister responsible for the Environment;
    -a representative of the Minister responsible for Health;
    -a representative of the Minister responsible for Consumer Affairs ;
    -a representative of the Minister responsible for agriculture;
    -a representative of the Minister responsible for industry;
    -a representative of the Minister responsible for research;
    -a representative of the Minister responsible for transportation;
    -one Representative of the Minister responsible for labour;
    -a representative of the Minister responsible for the interior;
    3 ° Two representatives of the Union of Chemical Industries;
    -a producer of chemicals or biocidal active substances;
    - A biocidal product formulator;
    -an industrial or professional user of biocidal products;
    -a biocidal product distributor;
    -three representatives of health associations, consumers or The environment;
    -three employees' representatives, appointed by the most representative trade unions;
    4 ° A representative of the French Environmental Health Safety Agency;
    -a representative of the recognised organisation By the Minister responsible for labour under the fourth paragraph of Article L. 231-7 of the Labour Code;
    -a representative of the Institut national de l' environnement industriel et des risques;
    -a representative of the French Agency for Food safety;
    -a representative of the French Health Products Safety Agency;
    -a representative of poison control centres.
    The members listed in 2 ° are appointed by the Minister of the Environment on The
    listed at 3 ° and 4 ° shall be appointed by order of the Minister responsible for the environment. The representatives of the organizations listed in the 4 ° are appointed by the Minister of the Environment on the proposal of each of the directors of these organizations. The representative of poison control centres shall be appointed by the Minister of the Environment on the proposal of the Director General of Health.
    The President, the Vice-Chair and the members of the Committee listed at 3 ° and 4 ° shall be appointed for a period of Three years renewable. An alternate shall be appointed at the same time as each full member and under the same conditions.
    When a member ceases to hold office, in particular because of the loss of quality as a result of which he has been appointed, his alternate shall replace him for The duration of the remaining term of office. A new alternate is named for this duration.
    II. -The secretariat of the committee is provided by the Directorate for the prevention of pollution and the risks of the Ministry responsible for the environment. The members of the secretariat shall attend the meetings of the committee.
    The committee shall meet on convocation by its Chairman.
    For the examination of the files, the Chairman shall designate one or more rapporteurs from among the members of the committee. The Commission may decide to hear any person of his or her choice. It may set up specialised working groups for which it lays down its composition and terms of reference.
    The members of the committee, as well as any person whom it consults, are bound to respect the confidentiality of the information they are brought to Know.
    Members of the Commission are free to perform their duties. It may, however, be granted compensation in respect of travel and subsistence expenses actually incurred at meetings, under the conditions laid down for the settlement of the travel expenses of civil servants. The state.
    The opinions of the Commission shall be issued to the majority of the members present or represented; in the event of an equal division of the votes, the voice of the Chairman shall be paramount.
    The Committee shall draw up its Rules of
    . Commission may not have exceeded the age of sixty-five years at the time of appointment or the renewal of their terms of reference

  • TITLE V: TRANSACTION AND TRANSITIONAL PROVISIONS Article 28


    The I of article R. 231-52-2 of the Labour Code is completed by an 8 ° reading:
    " 8 ° Chemicals which are used only as Biocidal active substances of biocidal products within the meaning of Article L. 522-1 of the Environment Code if they were placed on the market after 14 May 2000 or if, having been placed on the market before 14 May 2000, they were the subject of Decision to register on the lists referred to in Article L. 522-3 of the Environment Code. "

    Article 29


    The aforementioned decree of 12 February 1973 is amended as follows:
    I.-Article 11 is supplemented by a III. Written:
    " III. -The provisions of I and II of this Article and those taken for their application shall be repealed as they relate to the marketing authorisation and use of components which fall within the scope of the Chapter II of Title II of Book V of the Environmental Code and of the Decree adopted for its application
    However, the provisions referred to in the preceding paragraph shall remain in force under the conditions laid down in Article L. 522-18 of the Code. Of the environment for active substances and biocidal products referred to therein, until the intervention of a decision on their inclusion on the lists provided for in Article L. 522-3 of the same Code. "
    II. -Article 11-1 is supplemented by two sub-paragraphs thus written:
    " The provisions of this Article and those taken for its application shall be repealed as they relate to the entry of constituents entering the field Application of Chapter II of Title II of Book V of the Environment
    . However, the provisions referred to in the preceding paragraph shall remain in force under the conditions laid down in Article L. 522-18 of the Code of the Environment For active substances and biocidal products referred to therein, until the intervention of a decision on their inclusion on the lists provided for in Article L. 522-3 of the same Code. "

    Article 30


    The decree of 31 July 2001 is thus amended:
    I.-It is inserted, after Article 3, an Article 3-1 Thus written:
    " Art. 3-1. -The provisions of the first paragraph of Article 2 and those taken for its application shall be repealed as they relate to the marketing authorisation and the use of components which fall within the scope of the Chapter II of Title II of Book V of the Environmental Code and of the Decree adopted for its application
    However, the provisions referred to in the preceding paragraph shall remain in force under the conditions laid down in Article L. 522-18 of the Code of The environment for active substances and biocidal products referred to therein, until the intervention of a decision on their inclusion on the lists provided for in Article L. 522-3 of the same code
    Article 3 is not Applicable to biocidal active substances mentioned in the I of Article L. 522-18 of the Environment Code. "
    II. -The words: And those relating to the labelling of biocidal products " Are added as a result of the provisions contained in 3 of Article 5.
    III. -The statement: Or the provisions of Decree No. 2004-187 of 26 February 2004 transposing Directive 98 /8/EC of the European Parliament and of the Council of 16 February 1998 on the placing on the market of biocidal products " Is added to the Pursuant to the provisions of 1 ° or 2 ° of Article 6.

    Article 31


    After the first subparagraph of Article 1 Of the aforementioned decree of 30 August 1967, a second paragraph shall be inserted as follows: '
    ' Where the products referred to in the first subparagraph are biocidal products, they shall also be subject to the provisions of Decree No. 2004-187 of 26 February 2004 Implementing Directive 98 /8/EC of the European Parliament and of the Council of 16 February 1998 on the placing on the market of biocidal products. "

    Section 32


    The provisions of sections 26 and 27 of this Order come into force on January 1, 2005

    Style="text-decoration: none; "id="JORFARTI000001474506" name="JORFARTI000001474506"> Article 33


    The provisions of sections 13 to 15 of the Decree of February 13, 1985, are repealed effective January 1, 2005.

    Article 34


    The aforementioned Decree of 19 December 1997 is amended as follows:
    At 1 ° of Title II of the Annex, it is added The following title and table:
    " Decree n ° 2004-187 of 26 February 2004 transposing Directive 98 /8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing on the market of biocidal products


    You can view the table in OJ
    n ° 50, 28/02/2004, page 4095 to 4101


    Item 35


    The provisions of this Decree may be amended by decree in the Council of State, with the exception of those in the I, II and VI of Article 4, the last paragraph of Article 5, the I of Article 6, Article 8, the II, IV And VIII of article 9, article 10, fourth paragraph of article 11, articles 12, III and V of article 12, article 13, article 15, fourth paragraph of article 22, first paragraph of article 23, and article 34, which shall be Modified in accordance with the conditions set out in Article 2 of the Decree of 15 January 1997 referred to above.

    Article 36


    The Prime Minister, the Minister of Ecology and Sustainable Development and the Minister of the Public Service, of the reform of the State and of the regional planning shall be responsible, as far as it is concerned, for the application of this Decree, which shall be published in the Official Journal of the French Republic

Appendix


A N N E X E
TYPES OF BIOCIDES
Group 1
General disinfectants and biocidal products


Type of products 1: biocidal products for human hygiene.
Type of products 2: disinfectants used in the private and health fields Public and other biocidal products.
Type of products 3: biocidal products for veterinary hygiene.
Type of products 4: disinfectants for surfaces in contact with food and feed.
Type Of products 5: drinking water disinfectants.


Group 2
Protective Products


Type of products 6: Protective products used inside the containers.
Type of Products 7: Film protection products, films.
Type of products 8: wood protection products
Type of products 9: products for the protection of fibres, leather, rubber and polymerized materials.
Type of products 10: products
Type of products 11: products for the protection of liquids used in cooling and processing systems.
Type of products 12: antifungal products (antifungal, ...).
Type of Products 13: fluid protection products used in metal processing.


Group 3
Pest Control Products


Product Type 14: rodenticides
Type of products 15: Avicides.
Type of products 16: molluscicides.
Type of products 17: fish-icides.
Type of products 18: insecticides, acaricides and products used to control other arthropods.
Type of products 19: repellents and Bait.


Group 4
Other biocidal products


Type of products 20: food or feed protection products
Type of products 21: products Antifouling.
Type of products 22: fluids used for embalming and taxidermy.
Type of products 23: control of other vertebrates.


Done at Paris, February 26, 2004.


Jacques Chirac


By the President of the Republic:


The Prime Minister,

Jean-Pierre Raffarin

Minister of Ecology

and Sustainable Development,

Roselyne Bachelot-Narquin

The Minister of the Public Service,

of the reform of the

state and the development of Territory,

Jean-Paul Delevoye


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