Biocidal Products Regulation

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Article 2 Scope 1. This Regulation shall apply to biocidal products and treated articles. A list of the types of biocidal products covered by this Regulation and their descriptions is set out in Annex V. 2. Subject to any explicit provision to the … 911 unchanged words … 17.. 4. Article 69 shall not apply to the carriage of biocidal products by rail, road, inland waterway, sea or air. 5. This Regulation shall not apply to: (a) food or feed used as repellents or attractants; (b) biocidal products when used as processing aids. aids within the meaning of Regulation (EC) No 1831/2003 and Regulation (EC) No 1333/2008. 6. Biocidal products which obtained final approval under the International Convention for the Control and Management of Ships’ Ballast Water and Sediments shall be considered as authorised under Chapter VIII of this Regulation. Articles 47 and 68 shall apply accordingly. 7. Nothing in this Regulation shall prevent Member States from restricting or banning the use of biocidal products in the public supply of drinking water. 8. Member States may allow for exemptions from this Regulation in specific cases for certain biocidal products, on their own or in a treated article, where necessary in the interests of defence. 9. The disposal of active substances and biocidal products shall be carried out in accordance with the Union and national waste legislation in force.

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Article 3 Definitions 1. For the purposes of this Regulation, the following definitions shall apply: (a) biocidal product means any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, … 750 unchanged words … one of the product-types specified in Annex V; (r) single biocidal product means a biocidal product with no intended variations as to the percentage of the active or non-active substances it contains; (s) biocidal product family means a group of biocidal products having having: (i) similar uses, the active substances of which have uses; (ii) the same specifications, active substances; (iii) similar composition with specified variations; and presenting specified variations in their composition which do not adversely affect the level (iv) similar levels of risk or significantly reduce the efficacy of the products; and efficacy; (t) letter of access means an original document, signed by the data owner or its representative, which states that the data may be used for the benefit of a third party by competent authorities, the Agency, or the Commission for … 582 unchanged words … delegated acts in accordance with Article 83 in order to adapt the definition of nanomaterial set out in point (z) of paragraph 1 of this Article in view of technical and scientific progress and taking into account the Recommendation 2011/696/EU.

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Article 19 Conditions for granting an authorisation 1. A biocidal product other than those eligible for the simplified authorisation procedure in accordance with Article 25 shall be authorised provided the following conditions are met: (a) the active substances are included in Annex I or approved for the relevant product-type and any conditions specified for those active substances are met; (b) it is established, according to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI, that the biocidal product, when used as authorised and having regard to the factors referred to in paragraph 2 of this Article, fulfils the following criteria: (i) the biocidal product is sufficiently effective; (ii) the biocidal product has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates; (iii) the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects; (iv) the biocidal product has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations: the fate and distribution of the biocidal product in the environment, contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation, the impact of the biocidal product on non-target organisms, the impact of the biocidal product on biodiversity and the ecosystem; (c) the chemical identity, quantity and technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant and relevant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III; (d) the physical and chemical properties of the biocidal product have been determined and deemed acceptable for the purposes of the appropriate use and transport of the product; (e) where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product in accordance with Council Regulation (EEC) No 315/93 Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food OJ (OJ L 37, 13.2.1993, p. 1., 1)., Regulation (EC) No 1935/2004 396/2005 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food OJ L 338, 13.11.2004, p. 4., Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin OJ and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1., 1)., Regulation (EC) No 470/2009 of the European Parliament and of the Council Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin OJ origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11. 11). or Directive 2002/32/EC of the European Parliament and of the Council Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed OJ (OJ L 140, 30.5.2002, p. 10.; 10)., or specific migration limits or limits for the residual content in food contact materials have been established with respect to such active substances in accordance with Regulation (EC) No 1935/2004 of the European Parliament and of the Council Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).; (f) where nanomaterials are used in that product, the risk to human health, animal health and the environment has been assessed separately. 2. The evaluation of whether a biocidal product fulfils the criteria set out in point (b) of paragraph 1 shall take into account the following factors: (a) realistic worst case conditions under which the biocidal product may be used; (b) the way in which treated articles treated with the biocidal product or containing the biocidal product may be used; (c) the consequences of use and disposal of the biocidal product; (d) cumulative effects; (e) synergistic effects. 3. A biocidal product shall only be authorised for uses for which relevant information has been submitted in accordance with Article 20. 4. A biocidal product shall not be authorised for making available on the market for use by the general public where: (a) it meets the criteria according to Directive 1999/45/EC for classification as: toxic or very toxic, a category 1 or 2 carcinogen, a category 1 or 2 mutagen, or toxic for reproduction category 1 or 2; (b) it meets the criteria according to Regulation (EC) No 1272/2008 for classification as: acute oral toxicity category 1 or 1, 2 or 3, acute dermal toxicity category 1 or 1, 2 or 3, acute inhalation toxicity (gases and dust/mist) category 1 or 1, 2 or 3, acute inhalation toxicity (vapours) category 1 or 2, specific target organ toxicity by single or repeated exposure category 1, a category 1A or 1B carcinogen, a category 1A or 1B mutagen, or toxic for reproduction category 1A or 1B; (c) it consists of, contains or generates, a substance that meets the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006; (d) it has endocrine-disrupting properties; or (e) it has developmental neurotoxic or immunotoxic effects. 5. Notwithstanding paragraphs 1 and 4, a biocidal product may be authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) are not fully met, or may be authorised for making available on the market for use by the general public when the criteria referred to in paragraph 4(c) are met, where not authorising the biocidal product would result in disproportionate negative impacts for society when compared to the risks to human health, animal health or the environment arising from the use of the biocidal product under the conditions laid down in the authorisation. The use of a biocidal product authorised pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment to that biocidal product is minimised. The use of a biocidal product authorised pursuant to this paragraph shall be restricted to Member States in which the condition of the first subparagraph is met. 6. In The assessment of the case of a biocidal product family, a reduction family conducted according to the common principles set out in Annex VI shall consider the percentage maximum risks to human health, animal health and the environment and the minimum level of one or more active substances may be allowed, and/or a variation in percentage efficacy over the whole potential range of one or more non-active substances, and/or the replacement of one or more non-active substances by other specified substances presenting the same or lower risk. The classification, hazard and precautionary statements for each product products within the biocidal product family shall be the same (with the exception of a biocidal product family comprising a concentrate for professional use and ready-for-use products obtained through dilution of that concentrate). family. A biocidal product family shall be authorised only if if: (a) the application explicitly identifies the maximum risks to human health, animal health and the environment, and the minimum level of efficacy, on which the assessment is based, as well as the permitted variations in composition and uses referred to in point (s) of Article 3(1) together with their respective classification, hazard and precautionary statements and any appropriate risk mitigation measures; and (b) it can be established based on the assessment referred to in the first subparagraph of this paragraph that all the biocidal products within it, taking into account the permitted variations referred to in the first subparagraph, are expected to family comply with the conditions set out in paragraph 1. 7. Where appropriate, the prospective authorisation holder or its representative shall apply for the establishment of maximum residue limits with respect to active substances contained in a biocidal product in accordance with Regulation (EEC) No 315/93, Regulation (EC) No 1935/2004, Regulation (EC) No 396/2005, Regulation (EC) No 470/2009 or Directive 2002/32/EC. 2002/32/EC, or for the establishment of specific migration limits or limits for the residual content in food contact materials with respect to such substances in accordance with Regulation (EC) No 1935/2004. 8. Where, for active substances covered by Article 10(1)(a) of Regulation (EC) No 470/2009, no maximum residue limit has been established in accordance with Article 9 of that Regulation at the time of the approval of the active substance, or where a limit established in accordance with Article 9 of that Regulation needs to be amended, the maximum residue limit shall be established or amended in accordance with the procedure referred to in Article 10(1)(b) of that Regulation. 9. Where a biocidal product is intended for direct application to the external parts of the human body (epidermis, hair system, nails, lips and external genital organs), or to the teeth and the mucous membranes of the oral cavity, it shall not contain any non-active substance that may not be included in a cosmetic product pursuant to Regulation (EC) No 1223/2009.

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Article 23 Comparative assessment of biocidal products 1. The receiving competent authority or, in the case of an evaluation of an application for a Union authorisation, the evaluating competent authority, shall perform a comparative assessment as part of the evaluation of an application for authorisation or for renewal of authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 10(1). 2. The results of the comparative assessment shall be forwarded, without delay, to the competent authorities of other Member States and the Agency and, in the case of evaluation of an application for a Union authorisation, also to the Commission. 3. The receiving competent authority or, in the case of a decision on an application for a Union authorisation, the Commission Commission, shall prohibit or restrict the making available on the market or the use of a biocidal product containing an active substance that is a candidate for substitution where the a comparative assessment assessment, performed in accordance with Annex VI (comparative assessment) the technical guidance notes referred to in Article 24, demonstrates that both of the following criteria are met: (a) for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention method already exists which presents a significantly lower overall risk for human health, animal health and the environment, is sufficiently effective and presents no other significant economic or practical disadvantages; (b) the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target harmful organism. 4. By way of derogation from paragraph 1, a biocidal product containing an active substance that is a candidate for substitution may be authorised for a period of up to four years without comparative assessment in exceptional cases where it is necessary to acquire experience first through using that product in practice. 5. Where the comparative assessment involves a question which, by reason of its scale or consequences, would be better addressed at Union level, in particular where it is relevant to two or more competent authorities, the receiving competent authority may refer the question to the Commission for a decision. The Commission shall adopt that decision by means of implementing acts in accordance with the examination procedure referred to in Article 82(3). The Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying the criteria for determining when comparative assessments involve questions better addressed at Union level and the procedures for such comparative assessments. 6. Notwithstanding Article 17(4), and without prejudice to paragraph 4 of this Article, an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for a period not exceeding five years and renewed for a period not exceeding five years. 7. Where it is decided not to authorise or to restrict the use of a biocidal product pursuant to paragraph 3, that cancellation or amendment of the authorisation shall take effect four years after that decision. However, where the approval of the active substance which is a candidate for substitution expires on an earlier date, the cancellation of the authorisation shall take effect on that earlier date.

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Article 34 Mutual recognition in parallel 1. Applicants wishing to seek the mutual recognition in parallel of a biocidal product which has not yet been authorised in accordance with Article 17 in any Member State shall submit to the competent authority of the Member State of its choice (the reference Member State) an application containing: (a) the information referred to in Article 20; (b) a list of all other Member States where a national authorisation is sought (the Member States concerned). The reference Member State shall be responsible for the evaluation of the application. 2. The applicant shall, at the same time as submitting the application to the reference Member State in accordance with paragraph 1, submit to the competent authorities of each of the Member States concerned an application for mutual recognition of the authorisation for which it has applied to the reference Member State. This application shall contain: (a) the names of the reference Member State and of the Member States concerned; (b) the summary of biocidal product characteristics referred to in Article 20(1)(a)(ii) in such official languages of the Member States concerned as they may require. 3. The competent authorities of the reference Member State and of the Member States concerned shall inform the applicant of the fees payable in accordance with Article 80 and shall reject the application if the applicant fails to pay the fees within 30 days. They shall inform the applicant and the other competent authorities accordingly. Upon receipt of the fees payable under Article 80, the competent authorities of the reference Member State and of the Member States concerned shall accept the application and inform the applicant indicating the date of acceptance. 4. The reference Member State shall validate the application in accordance with Article 29(2) and (3) and inform the applicant and the Member States concerned accordingly. Within 365 days of validating an application, the reference Member State shall evaluate the application and draft an assessment report in accordance with Article 30(3) 30 and shall send its assessment report and the summary of biocidal product characteristics to the Member States concerned and to the applicant. 5. Within 90 days of receipt of the documents referred to in paragraph 4, and subject to Articles 35, 36 and 37, the Member States concerned shall agree on the summary of biocidal product characteristics, and shall record their agreement in the Register for Biocidal Products. The reference Member State shall enter the agreed summary of biocidal product characteristics and the final assessment report in the Register for Biocidal Products, together with any agreed terms or conditions imposed on the making available on the market or use of the biocidal product. 6. Within 30 days of reaching agreement, the reference Member State and each of the Member States concerned shall authorise the biocidal product in conformity with the agreed summary of biocidal product characteristics. 7. Without prejudice to Articles 35, 36, and 37, if no agreement is reached within the 90-day period referred to in paragraph 5, each Member State that agrees to the summary of biocidal product characteristics referred to in paragraph 5 may authorise the product accordingly.

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Article 35 Referral of objections to the coordination group 1. A coordination group shall be set up to examine any question, other than matters referred to in Article 37, relating to whether a biocidal product for which an application for mutual recognition has been made in accordance with Article 33 or 34 meets the conditions for granting an authorisation laid down in Article 19. All Member States and the Commission shall be entitled to participate in the work of the coordination group. The Agency shall provide the secretariat of the coordination group. The coordination group shall establish its rules of procedure. 2. If any of the Member States concerned considers that a biocidal product assessed by the reference Member State does not meet the conditions laid down in Article 19, it shall send a detailed explanation of the points of disagreement and the reasons for its position to the reference Member State, the other Member States concerned, the applicant, and, where applicable, to the authorisation holder. The points of disagreement shall be referred without delay to the coordination group. 3. Within the coordination group, all Member States referred to in paragraph 2 of this Article shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make its point of view known. Where they reach agreement within 60 days of the referral of the points of disagreement referred to in paragraph 2 of this Article, the reference Member State shall record the agreement in the Register for Biocidal Products. The procedure shall then be considered to be closed and the reference Member State and each of the Member States concerned shall authorise the biocidal product in accordance with Article 33(4) 33(3) or Article 34(6) as appropriate.

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Article 37 Derogations from mutual recognition 1. By way of derogation from Article 32(2), any of the Member States concerned may propose to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted, provided that such a measure can be justified on grounds of: (a) the protection of the environment; (b) public policy or public security; (c) the protection of health and life of humans, particularly of vulnerable groups, or of animals or plants; (d) the protection of national treasures possessing artistic, historic or archaeological value; or (e) the target organisms not being present in harmful quantities. Any of the Member States concerned may, in particular, propose in accordance with the first subparagraph to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted for a biocidal product containing an active substance to which Article 5(2) or Article 10(1) applies. 2. The Member State concerned shall communicate to the applicant a detailed statement of the grounds for seeking a derogation pursuant to paragraph 1 and shall seek to reach an agreement with the applicant on the proposed derogation. If the Member State concerned is unable to reach agreement with the applicant or receives no reply from the applicant within 60 days of that communication it shall inform the Commission. In that case, the Commission: (a) may ask the Agency for an opinion on scientific or technical questions raised by the applicant or the Member State concerned; (b) shall adopt a decision on the derogation in accordance with the examination procedure referred to in Article 82(3). The Commission’s decision shall be addressed to the Member State concerned and the Commission shall inform the applicant thereof. The Member State concerned shall take necessary measures to comply with the Commission’s decision within 30 days of its notification. 3. If the Commission has not adopted a decision pursuant to paragraph 2 within 90 days of being informed in accordance with the second subparagraph of paragraph 2, the Member State concerned may implement the derogation proposed pursuant to paragraph 1. While the procedure under this Article is ongoing, the Member States’ States obligation to authorise a biocidal product within two three years of the date of approval, referred to in the first subparagraph of Article 89(3), shall be temporarily suspended. 4. By way of derogation from Article 32(2), a Member State may refuse to grant authorisations for product-types 15, 17 and 20 on grounds of animal welfare. Member States shall without delay inform other Member States and the Commission of any decision taken in this respect and its justification.

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Article 52 Period of grace Notwithstanding Article 89, where the competent authority or, in the case of a biocidal product authorised at Union level, the Commission, cancels or amends an authorisation or decides not to renew it, it shall grant a period of grace for the disposal, making available on the market and use of existing stocks, except in cases where continued making available on the market or use of the biocidal product would constitute an unacceptable risk to human health, animal health or the environment. The period of grace shall not exceed 180 days for the making available on the market and an additional maximum period of 180 days for the disposal and use of existing stocks of the biocidal products concerned.

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Article 53 Parallel trade 1. A By way of derogation from Article 17, a competent authority of a Member State (Member State of introduction) shall, at the request of the applicant, grant a parallel trade permit for a biocidal product that is authorised in another Member State (Member State of origin) to be made … 664 unchanged words … parallel trade permit. 8. The competent authority of the Member State of introduction may withdraw a parallel trade permit if the authorisation of the introduced biocidal product is withdrawn in the Member State of origin because of safety or efficacy reasons.

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Article 54 Assessment of technical equivalence 1. Where it is necessary to establish the technical equivalence of active substances, the person seeking to establish that equivalence (the applicant) shall submit an application to the Agency and pay the applicable fees in accordance with Article 80(1). Agency. 2. The applicant shall submit all data that the Agency requires to assess technical equivalence. 3. The Agency shall inform the applicant of the fees payable under Article 80(1), 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant and the evaluating competent authority accordingly. 4. After giving the applicant the opportunity to submit comments, the Agency shall take a decision within 90 days of receipt of the application referred to in paragraph 1 and shall communicate it to Member States and to the applicant. 5. Where, in the opinion of the Agency, additional information is necessary to carry out the assessment of technical equivalence, the Agency shall ask the applicant to submit such information within a time limit specified by the Agency. The Agency shall reject the application if the applicant fails to submit the additional information within the specified time limit. The 90-day period referred to in paragraph 4 shall be suspended from the date of issue of the request until the information is received. The suspension shall not exceed 180 days except where justified by the nature of the data requested or in exceptional circumstances. 6. Where appropriate, the Agency may consult the competent authority of the Member State which acted as the evaluating competent authority for the evaluation of the active substance. 7. An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraphs 3, 4 and 5 of this Article. 8. The Agency shall draw up technical guidance notes to facilitate the implementation of this Article.

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Article 56 Research and development 1. By way of derogation from Article 17, an experiment or a test for the purposes of scientific or product and process-orientated research or and development involving an unauthorised biocidal product or a non-approved active substance intended exclusively for use in a biocidal product (experiment or test) may take place only under the conditions laid down provided for in this Article. Persons carrying out an experiment or test shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data, quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment. They shall make this information available to the competent authority on request. 2. Any person intending to carry out an experiment or test that may involve, or result in, release of the biocidal product into the environment shall first notify the competent authority of the Member State where the experiment or test will occur. The notification shall include the identity of the biocidal product or active substance, labelling data and quantities supplied, and all available data on possible effects on human or animal health or impact on the environment. The person concerned shall make available any other information requested by the competent authorities. In the absence of an opinion from the competent authority within 45 days of the notification referred to in the first subparagraph, the notified experiment or test may take place. 3. If the experiments or tests could have harmful effects, whether immediate or delayed, on the health of humans, particularly of vulnerable groups, or animals, or any unacceptable adverse effect on humans, animals or the environment, the relevant competent authority of the Member State concerned may prohibit them or allow them subject to such conditions as it considers necessary to prevent those consequences. The competent authority shall, without delay, inform the Commission and other competent authorities of its decision. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying detailed rules supplementing this Article.

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Article 58 Placing on the market of treated articles 1. This Article shall apply exclusively to treated articles that are not biocidal products. It shall not apply to treated articles where the sole treatment undertaken was the fumigation or disinfection of premises or containers used for storage or transport and where no residues are expected to remain from such treatment. 2. A treated article shall not be placed on the market unless all active substances contained in the biocidal products that it was treated with or incorporates are included in the list drawn up in accordance with Article 9(2), for the relevant product-type and use, or in Annex I, and any conditions or restrictions specified therein are met. 3. The person responsible for the placing on the market of such a treated article shall ensure that the label provides the information listed in the second subparagraph, where: in the case of a treated article containing a biocidal product, a claim is made by the manufacturer of that treated article regarding the … 430 unchanged words … incorporates does not meet the conditions laid down in Article 4(1), Article 5(2) or Article 25, the Commission shall review the approval of that active substance or its inclusion in Annex I in accordance with Article 15(1) or Article 28(2).

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Article 60 Data protection periods 1. Data submitted for the purposes of Directive 98/8/EC or of this Regulation shall benefit from data protection under the conditions laid down in this Article. The protection period for the data shall start when they are submitted for the first time. Data protected under this Article or for which the protection period under this Article has expired shall not be protected again. 2. The protection period for data submitted with a view to the approval of an existing active substance shall end 10 years from the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the relevant active substance for the particular product-type. The protection period for data submitted with a view to the approval of a new active substance shall end 15 years from the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the relevant active substance for the particular product-type. The protection period for new data submitted with a view to the renewal or review of the approval of an active substance shall end five years from the first day of the month following the date of the adoption of a decision in accordance with Article 14(4) concerning the renewal or the review. 3. The protection period for data submitted with a view to the authorisation of a biocidal product containing only existing active substances shall end 10 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 30(4), Article 34(6) 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or Article 44(4). 44(5). The protection period for data submitted with a view to the authorisation of a biocidal product containing a new active substance shall end 15 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 30(4), Article 34(6) 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or Article 44(4). 44(5). The protection period for new data submitted with a view to the renewal or amendment of the authorisation of a biocidal product shall end five years from the first day of the month following the decision concerning the renewal or amendment of the authorisation.

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Article 66 Confidentiality 1. Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents OJ L 145, 31.5.2001, p. 43. and the rules of the Management Board … 377 unchanged words … aid and medical advice to be given in the case of injury to persons. 4. Any person submitting information related to an active substance or a biocidal product to the Agency or a competent authority for the purposes of this Regulation can may request that the information in Article 67(3) shall and (4) not be made available, including a justification as to why the disclosure of the information could be harmful for their that person’s commercial interests or those of any other party concerned.

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Article 67 Electronic public access 1. From the date on which the Commission adopts an implementing Regulation providing that an active substance is approved, as referred to in point (a) of Article 9(1), the following up-to-date information held by the Agency or the Commission on that active substances substance shall be made publicly and easily available free of charge: (a) where available, the ISO name and the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature; (b) if applicable, the name as given in the European Inventory of Existing Commercial Chemical Substances; (c) the classification and labelling, including whether the active substance meets any of the criteria set out in Article 5(1); (d) physicochemical endpoints and data on pathways and environmental fate and behaviour; (e) the result of each toxicological and ecotoxicological study; (f) acceptable exposure level or predicted no-effect concentration established in accordance with Annex VI; (g) the guidance on safe use provided in accordance with Annexes II and III; (h) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 4.2 of Title 2 of Annex II. 2. From the date on which a biocidal product is authorised, the Agency shall make publicly and easily available free of charge the following up-to-date information: (a) the terms and conditions of the authorisation; (b) the summary of the biocidal product characteristics; and (c) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 5.2 of Title 2 of Annex III. 3. From the date on which the Commission adopts an implementing Regulation providing that an active substance is approved, as referred to in point (a) of Article 9(1), the Agency shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or the Agency as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to-date information on that active substances: substance: (a) if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives of active substances which are known to be hazardous; (b) the study summaries or robust study summaries of studies submitted to support the approval of the active substance; (c) information, other than that listed in paragraph 1 of this Article, contained in the safety data sheet; (d) the trade name(s) of the substance; (e) the assessment report. 4. From the date on which a biocidal product is authorised, the Agency shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or the Agency as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to date information: (a) study summaries, or robust study summaries, of studies submitted to support the biocidal product authorisation; and (b) the assessment report.

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Article 76 Secretariat of the Agency 1. The Secretariat of the Agency referred to in point (g) of Article 76(1) of Regulation (EC) No 1907/2006 shall undertake the following tasks: (a) establishing and maintaining the Register for Biocidal Products; (b) performing the tasks relating to the acceptance of the applications covered by this Regulation; (c) establishing technical equivalence; (d) providing technical and scientific guidance and tools for the application of this Regulation by the Commission and Member States’ competent authorities and providing support to national helpdesks; (e) providing advice and assistance to applicants, in particular to SMEs, for the approval of an active substance or its inclusion in Annex I to this Regulation or for a Union authorisation; (f) preparing explanatory information on this Regulation; (g) establishing and maintaining database(s) with information on active substances and biocidal products; (h) at the request of the Commission, providing technical and scientific support to improve cooperation between the Union competent authorities, international organisations and third countries on scientific and technical issues relating to biocidal products; (i) notification of decisions taken by the Agency; (j) specification of formats and software packages for the submission of information to the Agency; (k) providing support and assistance to Member States in order to avoid the parallel assessment of applications relating to the same or similar biocidal products referred to in Article 29(4); (l) providing support and assistance to Member States with regard to control and enforcement activities. 2. The Secretariat shall make the information identified in Article 67 publicly available, free of charge, over the internet, except where a request made under Article 66(4) is considered justified. The Agency shall make other information available on request in accordance with Article 66.

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Article 77 Appeal 1. Appeals against decisions of the Agency taken pursuant to Article Articles 7(2), Article 13(3), Article 26(2), Article 43(2), Article 43(2) and 45(3), Article 54(3), (4) and (5), Article and Articles 63(3) and Article 64(1) shall lie with the Board of Appeal set up in accordance with Regulation (EC) No 1907/2006. Article 92(1) and (2) and Articles 93 and 94 of Regulation (EC) No 1907/2006 shall apply to appeal procedures lodged under this Regulation. Fees may be payable, in accordance with Article 80(1) of this Regulation, by the person bringing an appeal. 2. An appeal lodged pursuant to paragraph 1 shall have suspensive effect.

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Article 78 The budget of the Agency 1. For the purposes of this Regulation, the revenues of the Agency shall consist of: (a) a subsidy from the Union, entered in the general budget of the European Union (Commission Section); (b) the fees paid to the Agency in accordance with this Regulation; (c) any charges paid to the Agency for services that it provides under this Regulation; (d) any voluntary contributions from Member States. 2. Revenue and expenditure for activities related to this Regulation and to Regulation (EC) No 1907/2006 shall be dealt with separately in the Agency’s budget and shall have separate budgetary and accounting reporting. Revenue Revenues of the Agency as referred to in Article 96(1) of Regulation (EC) No 1907/2006 shall not be used for carrying out tasks under this Regulation. Revenue Regulation, unless for a joint purpose or a temporary transfer to ensure the proper functioning of the Agency. Revenues of the Agency as referred to in paragraph 1 of this Article shall not be used for carrying out tasks under Regulation (EC) No 1907/2006. 1907/2006, unless for a joint purpose or a temporary transfer to ensure the proper functioning of the Agency.

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Article 86 Active substances included in Annex I to Directive 98/8/EC The active Active substances included for which the Commission has adopted directives including them in Annex I to Directive 98/8/EC shall be deemed to have been approved under this Regulation on the date of inclusion and shall be included in the list referred to in Article 9(2).Approval shall be subject to the conditions set out in those Commission directives.

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Article 89 Transitional measures 1. The Commission shall carry on with the work programme for the systematic examination of all existing active substances commenced in accordance with Article 16(2) of Directive 98/8/EC with the aim of achieving it by 31 December 2024. To that end, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the carrying out of the work programme and specification of the related rights and obligations of the competent authorities and the participants in the programme. Depending upon the progress of the work programme, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the extension of the duration of the work programme for a determined period. In order to facilitate a smooth transition from Directive 98/8/EC to this Regulation, during the work programme the Commission shall adopt either implementing regulations providing that an active substance is approved, and under which conditions, or, in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, implementing decisions stating that an active substance is not approved. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3). Regulations approving an active substance shall specify the date of approval. Article 9(2) shall apply. 2. By way of derogation from Article Articles 17(1), Article 19(1) and Article 20(1) of this Regulation, and without prejudice to paragraphs 1 and 3 of this Article, a Member State may continue to apply its current system or practice of making available on the market or using a given biocidal product available on the market until two for up to three years after the date of approval of the last of the active substances to be approved in that biocidal product. It The Member State concerned may, according to in accordance with its national rules, authorise the making available on the market or use in its territory only of a biocidal product containing only: (a) existing active substances which which: (i) have been or are being evaluated under Commission Regulation (EC) No 1451/2007 Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC OJ of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3., 3)., but which have not yet been approved for that product-type. product-type; or (ii) are being evaluated, under Regulation (EC) No 1451/2007, but which have not yet been approved for that product-type; or (b) a combination of active substances referred to in point (a) and active substances approved in accordance with this Regulation. By way of derogation from the first subparagraph, in the case of a decision not to approve an active substance, a Member State may continue to apply its current system or practice of making biocidal products available on the market for up to 12 months after the date of the decision not to approve an active substance in accordance with the third subparagraph of paragraph 1. 1, and may continue to apply its current system or practice of using biocidal products for up to 18 months after that decision. 3. Following a decision to approve a particular active substance for a specific product-type product-type, Member States shall ensure that authorisations for biocidal products of that product-type and containing that active substance are granted, modified or cancelled cancelled, as appropriate appropriate, in accordance with this Regulation within two three years of the date of approval. To that effect, those wishing to apply for the authorisation or mutual recognition in parallel of biocidal products of that product-type containing no active substances other than existing active substances shall submit applications for authorisation or mutual recognition in parallel to Member States’ competent authorities no later than the date of approval of the active substance(s). In the case of biocidal products containing more than one active substance, applications for authorisation shall be submitted no later than the date of approval of the last active substance for that product-type. Where no application for authorisation or mutual recognition in parallel has been submitted in accordance with the second subparagraph: (a) the biocidal product shall no longer be made available on the market with effect from 180 days after the date of approval of the active substance(s); and (b) disposal and use of existing stocks of the biocidal product may continue until for up to 365 days after the date of approval of the active substance(s). 4. Where a Member State’s competent authority rejects authority, or where relevant, the Commission, decides to reject an application submitted in accordance with paragraph 3 for authorisation of a biocidal product submitted under paragraph 3 already made available on the market, or decides not to grant authorisation, that an authorisation or to impose conditions for the authorisation making it necessary to change such a product, the following shall apply: (a) a biocidal product which has not been authorised or, where relevant, which does not comply with the conditions of the authorisation, shall no longer be made available on the market with effect from 180 days after the date of such rejection or decision. Disposal the decision of the authority; and (b) use of existing stocks of such the biocidal products product may continue until for up to 365 days after the date of such rejection or decision. the decision of the authority.

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Article 92 Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC 1. Biocidal products for which an authorisation or registration in accordance with Article 3, 4, 15 or 17 of Directive 98/8/EC was granted before 1 September 2013 can continue to be made available on the market and used subject, where applicable, to any conditions of authorisation or registration stipulated under that Directive until the expiry date of the authorisation or registration or its cancellation. 2. Notwithstanding paragraph 1, this Regulation shall apply to biocidal products referred to in that paragraph from 1 September 2013.Biocidal products authorised in accordance with Article 3 or 4 of Directive 98/8/EC shall be considered as authorised in accordance with Article 17 of this Regulation.

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before (02012R0528-20130923)

Article 93
Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC
1. Without prejudice to Article 89, applications for authorisation of biocidal products not covered by the scope of Directive 98/8/EC and falling within the scope of this Regulation and which were available on the market on 1 September 2013 shall be submitted at the latest by 1 September 2017.
2. By way of derogation from Article 17(1), biocidal products referred to in paragraph 1 of this Article for which an application was submitted in accordance with paragraph 1 of this Article may continue to be made available on the market or used until the date of the decision granting the authorisation. In the case of a decision refusing to grant the authorisation, the biocidal product shall no longer be made available on the market 180 days after such a decision.
By way of derogation from Article 17(1), biocidal products referred to in paragraph 1 of this Article for which an application was not submitted in accordance with paragraph 1 of this Article may continue to be made available on the market or used until 180 days after 1 September 2017.
Disposal and use of existing stocks of biocidal products which are not authorised for the relevant use by the competent authority or the Commission may continue until 365 days after the date of the decision referred to in the first subparagraph or 12 months after the date referred to in the second subparagraph, whichever is the later.

after (02012R0528-20140425)

Article 93
Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC
By way of derogation from Article 17(1), a Member State may continue to apply its current system or practice of making available on the market and using a biocidal product not covered by the scope of Directive 98/8/EC, but falling within the scope of this Regulation, and consisting of, containing or generating only active substances that were available on the market, or used in biocidal products, on 1 September 2013. The derogation shall apply until one of the following dates:
(a) where applications for approval of all those active substances, which the biocidal product consists of, contains or generates, are submitted for the relevant product-type by 1 September 2016, the deadlines provided for in the second subparagraph of Article 89(2), in Article 89(3) and in Article 89(4); or
(b) where an application is not submitted in accordance with point (a) for one of the active substances, until 1 September 2017.

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before (02012R0528-20130923)

Article 94
Transitional measures concerning treated articles
1. By way of derogation from Article 58 and without prejudice to Article 89, treated articles that were available on the market on 1 September 2013 may, until the date of a decision concerning the approval for the relevant product-type of the active substance(s) contained in the biocidal products with which the treated articles were treated or which they incorporate, continue to be placed on the market if the application for the approval of the active substance(s) for the relevant product-type is submitted at the latest by 1 September 2016.
2. In the case of a decision not to approve an active substance for the relevant product-type, treated articles which were treated with, or which incorporate, biocidal product(s) containing that active substance shall no longer be placed on the market 180 days after such a decision or as of 1 September 2016, whichever is the later, unless an application for the approval has been submitted in accordance with paragraph 1.

after (02012R0528-20140425)

Article 94
Transitional measures concerning treated articles
1. By way of derogation from Article 58(2), a treated article treated with or intentionally incorporating one or more biocidal products containing only active substances that are under examination for the relevant product-type in the work programme referred to in Article 89(1) on 1 September 2016 or for which an application for approval for the relevant product-type is submitted by that date, or containing only a combination of such substances and active substances included in the list drawn up in accordance with Article 9(2) for the relevant product-type and use or included in Annex I, may be placed on the market until one of the following dates:
(a) in the case of a decision adopted after 1 September 2016 to reject the application for approval of, or not to approve, one of the active substances for the relevant use, the date falling 180 days after such a decision;
(b) in other cases, the date of approval for the relevant product-type and use of the last active substance to be approved and contained in the biocidal product.
2. By way of further derogation from Article 58(2), a treated article treated with or intentionally incorporating one or more biocidal products containing any active substances other than those referred to in paragraph 1 of this Article or those included in the list drawn up in accordance with Article 9(2) for the relevant product-type and use or included in Annex I, may be placed on the market until 1 March 2017.

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before (02012R0528-20130923)

Article 95
Transitional measures concerning access to the active substance dossier
1. As of 1 September 2013, any person wishing to place active substance(s) on the Union market on its own or in biocidal products (the relevant person) shall, for every active substance that they manufacture or import for use in biocidal products, submit to the Agency:
(a) a dossier complying with the requirements of Annex II or, where appropriate, with Annex IIA to Directive 98/8/EC; or
(b) a letter of access to a dossier as referred to under point (a); or
(c) a reference to a dossier as referred to under point (a) and for which all data protection periods have expired.
If the relevant person is not a natural or legal person established within the Union, the importer of the biocidal product containing such active substance(s) shall submit the information required under the first subparagraph.
For the purposes of this paragraph and for existing active substances listed in Annex II to Regulation (EC) No 1451/2007, Article 63(3) of this Regulation shall apply to all toxicological and ecotoxicological studies including any toxicological and ecotoxicological studies not involving tests on vertebrates.
The relevant person to whom a letter of access to a dossier on the active substance has been issued shall be entitled to allow applicants for the authorisation of a biocidal product containing that active substance to make reference to that letter of access for the purposes of Article 20(1).
By way of derogation from Article 60 of this Regulation, all data protection periods for substance/product-type combinations listed in Annex II to Regulation (EC) No 1451/2007, but not yet approved under this Regulation shall end on 31 December 2025.
2. The Agency shall make publicly available the list of persons that have made a submission in accordance with paragraph 1 or for whom it has taken a decision in accordance with Article 63(3). The list shall also contain the names of persons who are participants in the work programme established under the first subparagraph of Article 89(1) or have taken over the role of the participant.
3. Without prejudice to Article 93, as of 1 September 2015, a biocidal product shall not be made available on the market if the manufacturer or importer of the active substance(s) contained in the product, or where relevant, the importer of the biocidal product, is not included in the list referred to in paragraph 2.
Without prejudice to Articles 52 and 89, disposal and use of existing stocks of biocidal products containing an active substance, for which no relevant person is included in the list referred to in paragraph 2, may continue until 1 September 2016.
4. This Article shall not apply to active substances listed in Annex I in categories 1 to 5 and 7 or to biocidal products containing only such active substances.

after (02012R0528-20140425)

Article 95
Transitional measures concerning access to the active substance dossier
1. As of 1 September 2013, the Agency shall make publicly available and shall regularly update a list of all active substances, and all substances generating an active substance, for which a dossier complying with Annex II to this Regulation or with Annex IIA or IVA to Directive 98/8/EC and, where relevant, Annex IIIA to that Directive (the complete substance dossier) has been submitted and accepted or validated by a Member State in a procedure provided for by this Regulation or that Directive (the relevant substances). For each relevant substance, the list shall also include all persons having made such a submission or a submission to the Agency in accordance with the second subparagraph of this paragraph, and indicate their role as specified in that subparagraph, and the product-type(s) for which they have made a submission, as well as the date of inclusion of the substance in the list.
A person established within the Union who manufactures or imports a relevant substance, on its own or in biocidal products (the substance supplier) or who manufactures or makes available on the market a biocidal product consisting of, containing or generating that relevant substance (the product supplier), may at any time submit to the Agency either a complete substance dossier for that relevant substance, a letter of access to a complete substance dossier, or a reference to a complete substance dossier for which all data protection periods have expired. Following the renewal of the approval of an active substance, any substance supplier or product supplier may submit to the Agency a letter of access to all the data which was considered by the evaluating competent authority as relevant for the purpose of the renewal, and for which the protection period has not yet expired (the relevant data).
The Agency shall inform the submitting supplier of the fees payable under Article 80(1). It shall reject the application if the submitting supplier fails to pay those fees within 30 days and shall inform the submitting supplier accordingly.
Upon receipt of the fees payable under Article 80(1), the Agency shall verify whether the submission complies with the second subparagraph of this paragraph and shall inform the submitting supplier accordingly.
2. As of 1 September 2015, a biocidal product consisting of, containing or generating a relevant substance, included in the list referred to in paragraph 1, shall not be made available on the market unless either the substance supplier or the product supplier is included in the list referred to in paragraph 1 for the product-type(s) to which the product belongs.
3. For the purposes of making a submission in accordance with the second subparagraph of paragraph 1 of this article, Article 63(3) of this Regulation shall apply to all toxicological, ecotoxicological and environmental fate and behaviour studies relating to substances listed in Annex II to Regulation (EC) No 1451/2007, including any such studies not involving tests on vertebrates.
4. A substance supplier or a product supplier included in the list referred to in paragraph 1 to whom a letter of access has been issued for the purpose of this Article or a right to refer to a study has been granted in accordance with paragraph 3 shall be entitled to allow applicants for the authorisation of a biocidal product to make reference to that letter of access or that study for the purposes of Article 20(1).
5. By way of derogation from Article 60, all data protection periods for active substance/product-type combinations listed in Annex II to Regulation (EC) No 1451/2007, but for which a decision on inclusion in Annex I to Directive 98/8/EC was not taken before 1 September 2013, shall end on 31 December 2025.
6. Paragraphs 1 to 5 shall not apply to substances listed in Annex I in categories 1 to 5 and category 7 or to biocidal products containing only such substances.
7. The Agency shall regularly update the list referred to in paragraph 1 of this Article. Following the renewal of the approval of an active substance, the Agency shall remove from the list any substance supplier or product supplier who has not, within 12 months of the renewal, submitted all the relevant data or a letter of access to all the relevant data, either in accordance with the second subparagraph of paragraph 1 of this Article or in an application in accordance with Article 13.

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Article 96 Repeal Without prejudice to Articles 86, 89, 90, 91 89 to 93 and 92 95 of this Regulation, Directive 98/8/EC is hereby repealed with effect from 1 September 2013. References to the repealed Directive shall be construed as references to this Regulation and read in accordance with the correlation table in Annex VII.

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ANNEX I LIST OF ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 25(a) EC number Name/group Restriction Comment Category 1 — Substances authorised as food additives according to Regulation (EC) No 1333/2008 200-018-0 Lactic acid Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 E 270 204-823-8 Sodium acetate Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 E 262 208-534-8 Sodium benzoate Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 E 211 201-766-0 (+)-Tartaric acid Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 E 334 200-580-7 Acetic acid Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 E 260 201-176-3 Propionic acid Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 E 280 Category 2 — Substances included in Annex IV to Regulation (EC) No 1907/2006 200-066-2 Ascorbic acid 232-278-6 Linseed oil Category 3 — Weak acids Category 4 — Traditionally used substances of natural origin Natural oil Lavender oil CAS 8000-28-0 Natural oil Peppermint oil CAS 8006-90-4 Category 5 — Pheromones 222-226-0 Oct-1-en-3-ol Mixture Webbing clothes moths pheromone Category 6 — Substances included for which a Member State has validated an active substance dossier in Annex I accordance with Article 7(3) of this Regulation or IA to accepted such a dossier in accordance with Article 11(1) of Directive 98/8/EC 204-696-9 Carbon dioxide Only for use in ready-for-use gas canisters functioning together with a trapping device 231-783-9 Nitrogen Only for use in limited quantities in ready-for-use canisters 250-753-6 (Z,E)-Tetradec-9,12-dienyl Not available (9Z,12E)-tetradeca-9,12-dien-1-yl acetate CAS 30507-70-1 Category 7 — Other Baculovirus 215-108-5 Bentonite 203-376-6 Citronellal 231-753-5 Iron sulphate

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ANNEX III INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS 1. This Annex sets out the information requirements that shall be included in the dossier for the biocidal product accompanying an application for the approval of an active substance in accordance with point (b) of … 2,258 unchanged words … on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/ECand Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected 8.3. Skin sensitisationThe sensitisation The assessment of this endpoint shall comprise the following consecutive steps: 1. an assessment of the available human, animal and alternative data 2. in vivo testing The Murine Local Lymph Node Assay (LLNA) including, where appropriate, the reduced variant of the assay, is the … 3,242 unchanged words … Packaging (type, materials, size, etc.), compatibility of the product with proposed packaging materials to be included 13. SUMMARY AND EVALUATION The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed

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ANNEX V BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1) MAIN GROUP 1: Disinfectants These product-types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products. Product-type 1: Human hygiene Products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp. Product-type 2: Disinfectants and algaecides not intended for direct application to humans or animals Products used for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact with food or feeding stuffs. Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls and floors in private, public, and industrial areas and in other areas for professional activities. Products used for disinfection of air, water not used for human or animal consumption, chemical toilets, waste water, hospital waste and soil. Products used as algaecides for treatment of swimming pools, aquariums and other waters and for remedial treatment of construction materials. Products used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties. Product-type 3: Veterinary hygiene Products used for veterinary hygiene purposes such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function. Products used to disinfect the materials and surfaces associated with the housing or transportation of animals. Product-type 4: Food and feed area Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals. Products used to impregnate be incorporated into materials which may enter into contact with food. Product-type 5: Drinking water Products used for the disinfection of drinking water for both humans and animals. MAIN GROUP 2: Preservatives Unless otherwise stated these product-types include only products to prevent microbial and algal development. Product-type 6: … 528 unchanged words … fouling organisms (microbes and higher forms of plant or animal species) on vessels, aquaculture equipment or other structures used in water. Product-type 22: Embalming and taxidermist fluids Products used for the disinfection and preservation of human or animal corpses, or parts thereof.