The keystones of the proposed approach, presented in section 4 of that document, were the followings:

Transcription

1 EUROPEAN COMMISSION DIRECTORATE-GENERAL ENVIRONMENT Directorate D - Water, Marine Environment & Chemicals ENV.D.3 - Chemicals, Biocides and Nanomaterials CA-Feb13-Doc.5.1.l ACTIVE SUBSTANCES IN ANNEX I OF THE BPR AND THE SIMPLIFIED AUTHORISATION PROCEDURE 1. BACKGROUND This document is a follow up to the document "CA-Dec12-Doc.5.1.j Substances in Annex I of the BPR.doc" discussed during the 49 th CA meeting in December 2012 (enclosed in the Appendix to the present document), which intended to make a summary of the provisions foreseen in the BPR concerning active substances in Annex I, and to outline a possible approach to include additional active substances into that Annex taking into account the objectives of the simplified authorisation procedure. The keystones of the proposed approach, presented in section 4 of that document, were the followings: (1) Any active substances can be included in Annex I, and not only substances that were at the origin of these provisions (food additives, weak acid, pheromones, traditionally used substances, substances listed in annex IV of REACH and Annex IA of the BPD), provided that there is evidence that the substance does not give rise to concern according to Article 28(1) and (2) of the BPR. (2) This possibility is open to all substances currently under the review programme, as some of them might fulfil the criteria for being considered as a substance not giving rise to concern. Such condition should be verified during the assessment. Such substance would be both included in Annex I of the BPR, and approved under the BPR for the PT(s) that are supported in the review programme, with specific provisions where appropriate. (3) The name of Category 6 of Annex I should be modified to cover substances that would be added to this Annex on a basis of a dossier with proprietary data (ex: most existing active substances under the current review programme), because provisions of Article 95 of the BPR on the list of suppliers only apply to this category. 2. WAY FORWARD Member States are invited to endorse document "CA-Dec12-Doc.5.1.j Substances in Annex I of the BPR.doc". The next step will be to work on more detailed procedures that would be needed to add new active substances in this Annex I, and the data requirements associated to such addition.

2 APPENDIX

3 EUROPEAN COMMISSION DIRECTORATE-GENERAL ENVIRONMENT Directorate D - Water, Marine Environment & Chemicals ENV.D.3 - Chemicals, Biocides and Nanomaterials CA-Dec12-Doc.5.1.j ACTIVE SUBSTANCES IN ANNEX I OF THE BPR AND THE SIMPLIFIED AUTHORISATION PROCEDURE 1. PURPOSE OF THE DOCUMENT The purpose of this document is: - to make a summary of the provisions that are foreseen in the BPR concerning active substances already included, or eligible to inclusion, in Annex I, - to outline a possible approach to include additional substances into Annex I with regards to the objective of the simplified authorisation procedure. The Commission services already received some informal requests of companies that would like to know more about these provisions, in order to have their active substance(s) listed in that Annex. This is a first step towards the implementation of these provisions, and it is essential to clarify these elements before starting to work actively on this topic. Therefore, the present document focuses on this objective, and does address neither the establishment of detailed procedures that would be needed to add new active substances in this Annex I, nor the data requirements associated to such addition. These will be addressed in another document in the future. 2. BACKGROUND As defined in the recitals of the BPR, the use of products with a more favourable environmental or human or animal health profile shall be encouraged. One of the measures that were introduced in the BPR to fulfil this objective is to provide for simplified authorisation procedures for specific products that are expected to present such characteristics. Among other criteria, such products should contain only active substances that are listed in Annex I of the BPR. The legislators chose to limit this list initially to substances identified as presenting a low risk under Regulation (EC) No 1907/2006 or Directive 98/8/EC, substances identified as food additives, pheromones and other substances considered to have low toxicity, such as weak acids, alcohols and vegetable oils used in cosmetics and food. This list is limitative, and some substances are already listed in those

4 categories. The Commission is empowered to modify Annex I by delegated acts, in order to include, restrict or remove the entry of a substance in that Annex. 3. ACTIVE SUBSTANCES INCLUDED IN ANNEX I OF THE BPR: SUMMARY OF THE PROVISIONS OF THE BPR 3.1. Criteria applicable to an active substance in order to be listed in Annex I Specific criteria are defined in the BPR concerning the properties that active substances shall not have to be listed in that Annex. According to Article 28(1) and (2), active substances can be included in Annex I provided that there is evidence that they do not give rise to concern. A substance is considered to give rise to concern where : (a) it meets the criteria for classification according to Regulation (EC) No 1272/2008 as: explosive/highly flammable, organic peroxide, acutely toxic of category 1, 2 or 3, corrosive of category 1A, 1B or 1C, respiratory sensitiser, skin sensitiser, germ cell mutagen of category 1 or 2; carcinogen of category 1 or 2, human reproductive toxicant of category 1 or 2 or with effects on or via lactation, specific target organ toxicant by single or repeated exposure, or toxic to aquatic life of acute category 1; (b) it fulfils any of the substitution criteria set out in Article 10(1) [substitution criteria]; or (c) it has neurotoxic or immunotoxic properties. An active substance also gives rise to concern, even if none of the specific criteria in points (a) to (c) are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information. Most of the criteria are clearly specified (ex: explosive/highly flammable). On the other hand, some of them can be subject to interpretation, for instance the last paragraph of this Article 28(2) referring to a level of concern equivalent to those previously listed, or the reference to substitution criteria that are themselves, for a few of them, subject to interpretation. 4

5 Additional work will be needed in order to define what would be an equivalent level of concern. In addition, any interpretation to be taken on the substitution criteria, for consistency will also apply here Inclusion of an active substance in Annex I Commission can adopt a delegated act to include a substance in Annex I of the BPR, at its own initiative or at the request of an economic operator or a Member State. It can be done only after an ECHA opinion. There must be evidence that the substance does not give rise to concern. Further discussions on the detailed procedures to follow to include a substance in Annex I will be needed. Those discussions may lead to a guidance document, or to an implementing act, adopted via the examination procedure Restriction or removal of an active substance from Annex I Commission can adopt a delegated act in order to restrict or to remove the entry for an active substance, at its own initiative or at the request of an economic operator or a Member State. It can be done only after an ECHA opinion. There must be evidence that biocidal products containing that substance do not, in certain circumstances, satisfy the conditions set out: - in paragraph 1 of Article 28: it refers to the criteria for a substance to be considered as giving rise to concern. This provision has therefore to be understood in the way that Commission can take a delegated act to restrict or remove the entry of a substance when there is evidence that this substance gives rise to concern in certain circumstances; Or - in Article 25 1 : it refers to the conditions for a product to be eligible to the simplified procedure. Restrictions could therefore be made to ensure that some products that contain the active substance would be eligible to the simplified authorisation procedure, and that those expectations are realistic. In addition, a substance could be removed from Annex I if there is evidence that products containing that active substance would not, in fact, be eligible to the simplified procedure: for instance, if there is evidence that products are not sufficiently effective. Further discussions on the detailed procedures to follow to restrict or remove a substance in Annex I will be needed. Those discussions may lead either to a guidance document, either to an implementing act adopted via the examination procedure. 1 A biocidal product shall be eligible to the simplified authorisation procedure if all the following conditions are met: (a) all the active substances contained in the biocidal product appear in Annex I and satisfy any restriction specified in that Annex; (b) the biocidal product does not contain any substance of concern; (c) the biocidal product does not contain any nanomaterials; (d) the biocidal product is sufficiently effective; and (e) the handling of the biocidal product and its intended use do not require personal protective equipment. 5

6 3.4. Provisions applicable to active substances included in Annex I Restrictions /specific provisions Active substances on the market, as well as biocidal products that would be authorised according to the simplified procedure, have to comply with the restrictions or specific provisions mentioned in Annex I, if any. It can be highlighted that, for all substances listed so far in Annex I, no limitation is indicated regarding the "product type" (PT): this means that biocidal products that contain them and that are eligible to the simplified authorisation procedure can be placed on the market for an action falling within any PT, provided that conditions set out in Article 25 are fulfilled (i.e. no substance of concern, sufficiently effective etc ). It is assumed that substances of category 6 " Substances included in Annex I or IA to Directive 98/8/EC ", the limitation regarding the PT possibilities remains the same, even if not explicit, as it was the intention of the legislators to include them in Annex I because a low risk was demonstrated for a specific use and because the restrictions mentioned in Annex I refer to those PTs. It shall also be noted that "food additives" are covered by the definition of "food" as defined in Article 2 of regulation (EC) n 178/ Therefore, it can be recalled that, according to Article 2(5) of the BPR, food used as repellent or attractant (PT19) are excluded from the scope of the BPR. This applies to food additives listed in Annex I as well Duration of inclusion Contrary to other active substances, there is no limitation of time to their inclusion. Therefore, a substance included in Annex I is included as long as the BPR is in force Data protection According to Article 60(1), the protection period of any data submitted for the purpose of the regulation starts at the date of submission. Such rules of protection therefore apply to data that would be submitted for the inclusion of an active substance in Annex I of the BPR, or for a product authorisation according to the simplified procedure. Contrary to other active substances that will be approved and other biocidal product that will go through other authorisation procedure, it seems that no specific limitation of the protection has been foreseen so far in the provisions of Article 60, which would mean that those data would be protected with no limitation of time. It can however be argued 2 Regulation (EC) 178/2002, Art.2 : food (or foodstuff ) means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. Food includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. It includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC and without prejudice to the requirements of Directives 80/778/EEC and 98/83/EC. 6

7 that the legislators did not intend to give such unlimited protection, considering that all other data submitted in the BPR have a limitation of protection and that the objective of the measure is to facilitate the placing on the market of products with a more favourable environmental or human or animal health profile, including products of competitors that are comparable to other products already authorised through the simplified procedure. It shall be noted that substances of category 6 are currently both included in Annex I and Annex IA of the BPD, and will therefore be considered as also approved under the BPR. General rules of data protection will therefore apply to the data that were submitted during the review programme for those substances and those products (ie. 10 years of protection from the 1 st day the month following the date of adoption of a decision) Provisions of Article 95: (Alternative) suppliers of these active substances Except substances listed in category 6, all other active substances listed in Annex I do not need to comply with the provisions of Article 95. As a consequence, all manufacturers or importers could therefore place on the market such an active substance, provided that it is compliant with restrictions/specific provisions mentioned in Annex I, if any. For instance, for sodium acetate (EC n , food additive E262) mentioned in the category " Category 1 - Substances authorised as food additives according to Regulation (EC) No 1333/2008", this means that only sources that are allowed to be placed on the market and used as a food additive could be placed on the market for and used in products eligible to the simplified procedure (ie. of "food additive grade quality" substance). Regulation (EC) N 1333/2008 indeed foresees some limitations regarding impurities in food additives. For substances listed in category 6, the legislators have foreseen that companies responsible for the placing these active substances on the market for the purpose of being used to formulate biocidal product eligible to the simplified procedure will have to comply with the provisions of Article 95. In this case, an applicant supported those active substances under the BPD to include them in Annex I and IA, therefore the same rules as for the other substances in the review programme should therefore apply here Article 54 and technical equivalence Except for substances listed so far in category 6, no reference source has been defined. Data requirements in the application for product authorisation through the simplified procedure do not explicitly mention the need to submit a proof of establishment of technical equivalence of the sources. Therefore, it is proposed that: - for substances listed in category 1 to 5, and 7: as no reference source exists, the establishment of a technical equivalence is not relevant. - for substances listed in category 6 : a reference source has been set at the stage of the Annex IA inclusion in the BPD. Then, as the low risk was proven for those sources, it is 7

8 proposed to require the proof of technical equivalence to the reference source in the applications for the simplified authorisation procedure. Further discussions on the data requirements in the applications for product authorisation will be needed Product authorisation In order to benefit from the simplified procedure, a product have to fulfil several conditions, one of them is to contain only active substances included in Annex I and satisfying any restriction specified in that Annex. These active substances are included in Annex I and not approved under the BPR, except substances listed in category 6. This difference has its importance regarding the possibilities for placing on the market of biocidal products: such active substances cannot be used in products that will not be eligible to the simplified authorisation procedure, unless they are otherwise approved. 4. ADDITION OF ACTIVE SUBSTANCES IN ANNEX I 4.1. Categories of substances eligible for inclusion in Annex I The legislators chose to limit this list initially to substances identified as presenting a low risk under Regulation (EC) No 1907/2006 or Directive 98/8/EC, substances identified as food additives, pheromones and other substances considered to have low toxicity, such as weak acids, alcohols and vegetable oils used in cosmetics and food. Substances are currently divided into 7 different categories: - Category 1 Substances authorised as food additives according to Regulation (EC) No 1333/ Category 2 Substances included in Annex IV to Regulation (EC) No 1907/ Category 3 Weak acids - Category 4 Traditionally used substances of natural origin - Category 5 Pheromones - Category 6 Substances included in Annex I or IA to Directive 98/8/EC - Category 7 Other Further work will be needed to define more precisely what is covered by some of these categories, like "traditionally used substances of natural origin". Delegation has been given to the Commission in order to include, restrict or remove the entry of a substance in Annex I. 8

9 It is proposed that any kind of active substances can be included in Annex I, and not only substances that were at the origin of these provisions (food additives, weak acid, pheromones, and traditionally used substances). The basis for such an approach is that the only criteria foreseen in the core of the BPR for the inclusion of a substance in Annex I is to provide evidence that the substance does not give rise to concern according to Article 28(1) and (2). No other limitation is made on the profile of the substance. In addition, in recital 30 of the BPR, food additive, substance included in Annex IV of REACH, weak acids, traditionally used substances of natural origin and pheromones are only quoted as examples of substances of low risk. A distinction could be made between substances for which a large set of data would be submitted to support the inclusion, and substances for which only literature data would have been used: - the first ones could by preference be included into category 6, in order that Article 95 of the BPR on the list of suppliers apply to those substances and that the original applicant benefits from its data protection. The name of this category 6 would therefore need to be slightly amended. The possibility to amend the title of the category shall be examined. - the second ones could be included into the other categories, as only literature data would have been submitted and provisions of Article 95 would thus not be relevant for those substances. Further discussions on the data requirements that would be needed to prove that the substance do not give rise to concern, as well as on the data requirements in applications submitted for the simplified authorisation procedure (requirements to justify that they are eligible to the simplified authorisation procedure according to Article 25 of the BPR) will be needed Eligibility of existing/new active substances currently under the BPD review programme Some substances assessed in the BPD review programme are currently listed in Annex I of the BPR in category 6 " Substances included in Annex I or IA to Directive 98/8/EC ". Those substances are currently included in both Annex I and Annex IA of BPD. Other substances in the review programme might have been eligible to an Annex I and IA inclusion of the BPD. Those substances currently under assessment in the review programme might be eligible to an Annex I inclusion in the BPR, as they might fulfil the criteria for being considered as a substance not giving rise to concern. Such condition could be easily verified as full data package is normally available in applications already submitted in Rapporteur Member States. It is therefore proposed that this possibility is potentially open to all substances currently under the review programme. For those existing substances that would finally be eligible, it would be proposed that: 9

10 - they are both included in Annex I of the BPR, and approved under the BPR, in order that they can be used both in biocidal products eligible to the simplified procedure and in other biocidal products; - these inclusions and approvals are limited to the PT(s) that are supported in the review programme for those substances; - they are included by preference in category 6 of the Annex I, because provisions of Article 95 of the BPR on the list of suppliers only apply to this category. The name of this category would therefore need to be slightly amended. The possibility to amend the title of the category, or to create new categories, shall however be examined. Further discussions will be needed to define the procedures that would have to be followed to come to the inclusion of those substances, as they are currently under review by Rapporteur Member States, or under peer review at EU level. 5. CONCLUSION Commission would like to receive the views of the Member States and stakeholders on these provisions of the Regulation, and on the different interpretations, proposals and questions raised throughout the document. 10

11 ANNEX Extracts from the BPR in relation to substances included in Annex I and the simplified authorisation procedure Recitals (29) To encourage the use of products with a more favourable environmental or human or animal health profile, it is appropriate to provide for simplified authorisation procedures for such biocidal products. Once authorised in at least one Member State, those products should be allowed to be made available on the market in all Member States without the need for mutual recognition, under certain conditions. (30) To identify biocidal products which are eligible for simplified authorisation procedures, it is appropriate to establish a specific list of the active substances that those products may contain. That list should, initially, contain substances identified as presenting a low risk under Regulation (EC) No 1907/2006 or Directive 98/8/EC, substances identified as food additives, pheromones and other substances considered to have low toxicity, such as weak acids, alcohols and vegetable oils used in cosmetics and food. Articles CHAPTER IV GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS Article 20 Requirements for applications for authorisation 1. The applicant for an authorisation shall submit the following documents together with the application: [ ] (b) for biocidal products that the applicant considers meet the conditions laid down in Article 25: (i) a summary of the biocidal product characteristics as referred to in point (a)(ii) of this paragraph; (ii) efficacy data; and (iii) any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article The receiving competent authority may require that applications for national authorisation be submitted in one or more of the official languages of the Member State where that competent authority is situated. CHAPTER V SIMPLIFIED AUTHORISATION PROCEDURE Article 25 Eligibility for the simplified authorisation procedure For eligible biocidal products, an application for authorisation may be made under a simplified authorisation procedure. A biocidal product shall be eligible if all the following conditions are met: (a) all the active substances contained in the biocidal product appear in Annex I and satisfy any restriction specified in that Annex; (b) the biocidal product does not contain any substance of concern; 11

12 (c) the biocidal product does not contain any nanomaterials; (d) the biocidal product is sufficiently effective; and (e) the handling of the biocidal product and its intended use do not require personal protective equipment. Article 26 Applicable procedure 1. Applicants seeking the authorisation of a biocidal product meeting the conditions of Article 25 shall submit an application to the Agency, informing it of the name of the competent authority of the Member State that it proposes should evaluate the application and providing written confirmation that that competent authority agrees to do so. That competent authority shall be the evaluating competent authority. 2. The evaluating competent authority shall inform the applicant of the fees payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly. Upon receipt of the fees payable under Article 80(2), the evaluating competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance. 3. Within 90 days of accepting an application, the evaluating competent authority shall authorise the biocidal product if satisfied that the product meets the conditions laid down in Article Where the evaluating competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days. The evaluating competent authority shall, within 90 days of receipt of the additional information, authorise the biocidal product if satisfied, on the basis of the additional information submitted, that the product meets the conditions laid down in Article 25. The evaluating competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly. In such cases, where fees have been paid, part of the fees paid in accordance with Article 80(2) shall be reimbursed. Article 27 Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure 1. A biocidal product authorised in accordance with Article 26 may be made available on the market in all Member States without the need for mutual recognition. However, the authorisation holder shall notify each Member State no later than 30 days before placing the biocidal product on the market within the territory of that Member State and shall use the official language or languages of that Member State in the product s labelling, unless that Member State provides otherwise. 2. Where a Member State other than that of the evaluating competent authority considers that a biocidal product authorised in accordance with Article 26 has not been notified or labelled in accordance with paragraph 1 of this Article or does not meet the requirements of Article 25, it may refer that matter to the coordination group established in accordance with Article 35(1). Article 35(3) and Article 36 shall apply mutatis mutandis. Where a Member State has valid reasons to consider that a biocidal product authorised in accordance with Article 26 does not meet the criteria laid down in Article 25 and a decision pursuant to Articles 35 and 36 has not yet been taken, that Member State may provisionally restrict or prohibit making available on the market or use of that product on its territory. Article 28 Amendment of Annex I 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 83 amending Annex I, after receiving the opinion of the Agency, in order to include active substances provided that there is evidence that they do not give rise to concern according to paragraph 2 of this Article. 12

13 2. Active substances give rise to concern where: (a) they meet the criteria for classification according to Regulation (EC) No 1272/2008 as: explosive/highly flammable, organic peroxide, acutely toxic of category 1, 2 or 3, corrosive of category 1A, 1B or 1C, respiratory sensitiser, skin sensitiser, germ cell mutagen of category 1 or 2; carcinogen of category 1 or 2, human reproductive toxicant of category 1 or 2 or with effects on or via lactation, specific target organ toxicant by single or repeated exposure, or toxic to aquatic life of acute category 1; (b) they fulfil any of the substitution criteria set out in Article 10(1); or (c) they have neurotoxic or immunotoxic properties. Active substances also give rise to concern, even if none of the specific criteria in points (a) to (c) are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information. 3. The Commission shall also be empowered to adopt delegated acts in accordance with Article 83 amending Annex I, after receiving the opinion of the Agency, in order to restrict or to remove the entry for an active substance if there is evidence that biocidal products containing that substance do not, in certain circumstances, satisfy the conditions set out in paragraph 1 of this Article or in Article 25. Where imperative grounds of urgency so require, the procedure provided for in Article 84 shall apply to delegated acts adopted pursuant to this paragraph. 4. The Commission shall apply paragraph 1 or 3 at its own initiative or at the request of an economic operator or a Member State providing the necessary evidence as referred to in those paragraphs. Whenever the Commission amends Annex I it shall adopt a separate delegated act in respect of each substance. 5. The Commission may adopt implementing acts further specifying the procedures to be followed with respect to an amendment of Annex I. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3). [.] Article 95 Transitional measures concerning access to the active substance dossier 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. 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/ 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

14 Sodium acetate Sodium benzoate (+)-Tartaric acid Acetic acid 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 262 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 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 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 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/ Ascorbic acid Linseed oil Category 3 Weak acids Category 4 Traditionally used substances of natural origin Natural oil Lavender oil CAS Natural oil Peppermint oil CAS Category 5 Pheromones Oct-1-en-3-ol Mixture Webbing clothes moths pheromone Category 6 Substances included in Annex I or IA to Directive 98/8/EC Carbon dioxide Nitrogen (Z,E)-Tetradec- 9, dienyl acetate Category 7 Other Baculovirus Bentonite Citronellal Iron sulphate Only for use in ready-for-use gas canisters functioning together with a trapping device Only for use in limited quantities in ready-for-use canisters 14