Activities of Dan JØRGENSEN related to 2009/0076(COD)
Plenary speeches (2)
Placing on the market and use of biocidal products (debate)
Placing on the market and use of biocidal products (debate)
Amendments (157)
Amendment 103 #
Council position
Recital 9
Recital 9
(9) This Regulation should apply to biocidal products that, in the form in which they are supplied to the user, consist of, or contain or generate one or more active substances. It therefore should not apply to devices within industrial plants that generate biocidal products in situ or precursors for one or more active substances.
Amendment 103 #
Proposal for a regulation
Citation 1
Citation 1
Having regard to the Treaty establishing the European Communityon the Functioning of the EU, and in particular Article 95114, 192 and 168 thereof,
Amendment 105 #
Proposal for a regulation
Recital 3
Recital 3
(3) The purpose of this Regulation is to increase the free movement of biocidal products within the Community. In order to remove as far as possible obstacles to trade in biocidal products stemming from the different levels of protection in the Member States, harmonised and to ensure a high level of protection of both human and animal health and the environment. Particular attention should be paid to the protection of vulnerable groups of the population, including pregnant women, infants and children. The Precautionary principle should be applied to this regulation in order to ensure that substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment. In order to remove as far as possible obstacles to trade in biocidal products rules should be laid down for the approval of active substances and the placing on the market and use of biocidal products, including the rules on the mutual recognition of authorisations and on parallel trade.
Amendment 106 #
Council position
Recital 28
Recital 28
(28) To encourage the use of products with a more favourable environmental or human 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.
Amendment 110 #
Council position
Article 1 – paragraph 1
Article 1 – paragraph 1
1. The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the making available on the market and the use of biocidal products, whilst ensuring a high level of protection of both human and animal health and the environment. The provisions of this Regulation are underpinned by the precautionary principle, the aim of which is to safeguard the health. The provisions of this Regulation are underpinned by the precautionary principle, in order to ensure that active substances or products placed on the market do not have harmful effects ofn humans, animals and the environment. non-target species and the environment. Special attention shall be paid to protecting children, pregnant women and the sick. Or. en (Reinstatement of amendment 341 from first reading.)
Amendment 120 #
Council position
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘'biocidal product’s' means any substances, mixtures or articles, in the form in which it isthey are supplied to the user, consisting of, containing or generatingbeing the precursor for one or more active substances, with the primary intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action;
Amendment 123 #
Council position
Article 3 – paragraph 1 – point (f) - subparagraph 2 – indent 2 a (new)
Article 3 – paragraph 1 – point (f) - subparagraph 2 – indent 2 a (new)
Amendment 124 #
Council position
Article 3 – paragraph 1 – point s
Article 3 – paragraph 1 – point s
(s) ‘'biocidal product family’' means a group of biocidal products having similar uses, the active substances of which have the same specifications, or a change in the quantities of one or more of the non- active substances and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products;
Amendment 126 #
Council position
Article 3 – paragraph 1 – point aa
Article 3 – paragraph 1 – point aa
(aa) ‘"nanomaterial’" means nanomaterial as defined in Commissionany intentionally produced material that has one or more dimensions of the order of 100 nm or less or is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale. Properties that are characteristic of the nanoscale include: (i) those related to the large specific surface area of the materials considered; and/or (ii) specific physico-chemical properties that are different from those of the non- nanoform of the same material. No later than six months after the adoption of Recommendation 20../…/EC of … … … concerning the definition of nanomaterials; , the Commission shall make a legislative proposal to include the definition in this Regulation. Or. en (Partial reinstatement of amendment 34 of first reading.)
Amendment 128 #
Council position
Article 4 – paragraph 1
Article 4 – paragraph 1
1. An active substance shall be approvedincluded in Annex -I for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet the criteriafulfils the conditions laid down in point (b) of Article 18(1) taking into account the factors set out in Article 18(2) and (5). An active substance referred to in Article 5 may only be included in Annex I for an initial period of 5 years. (Note: This amendment applies throughout the text. If adopted, reference to "approval of an active substance" is to be replaced by reference to "inclusion of an active substance in Annex -I", reference to "approval" by "inclusion in Annex -I", reference to "approved" by "included in Annex -I" etc. throughout the text.) Or. en (Reinstatement of amendment 39 from first reading.)
Amendment 128 #
Proposal for a regulation
Article 1 – paragraph 1 – subparagraph 1 a
Article 1 – paragraph 1 – subparagraph 1 a
1a. The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment. The provisions of this Regulation are underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not have harmful effects on human or animal health or the environment. Member States shall not be prevented from applying the precautionary principle when there is scientific uncertainty as to the risks with regard to human or animal health or the environment posed by the biocide products to be authorised in their territory.
Amendment 129 #
Council position
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) active substances which, on the basis of the assessment of Union or internationally agreed test guidelines or other peer-reviewed scientific data and information, including a review of the scientific literature, reviewed by the Agency, are considered as having endocrine-disrupting properties that may cause adverse effect in humans, or which are identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties; . Or. en (Reinstatement of part of amendment 44 from first reading.)
Amendment 131 #
Council position
Article 5 – paragraph 2 – subparagraph 1 – point a
Article 5 – paragraph 2 – subparagraph 1 – point a
(a) the risk to humans or the environment from exposure to the active substance in a biocidal product, under realistic worst case conditions of use, is negligible, in particular wheremeaning that the product is used in closed systems or strictly controlled conditions; under other conditions excluding contact with humans; Or. en (Reinstatement of part of amendment 44 from first reading.)
Amendment 131 #
Proposal for a regulation
Article 2 – paragraph 2 – point p a (new)
Article 2 – paragraph 2 – point p a (new)
pa. Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption;
Amendment 133 #
Council position
Article 5 – paragraph 2 – subparagraph 1 – point b
Article 5 – paragraph 2 – subparagraph 1 – point b
(b) it is shown by evidence that the active substance is essentialnecessary to prevent or to control a serious danger to public or animal health or to the environment; or (Reinstatement of part of amendment 44 from first reading. Linked to the amendment deleting, to food and feed safety, or to the public interest and that there are no effective alternative substances or technologies available. The use of any biocidal product containing active substances included in Annex I pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment is minimised. Member State authorising a biocidal product containing an active substance included in Annex I pursuant to this paragraph shall draw up a substitution plan concerning the control of the serious danger by other means including non- chemical methods, which are as effective as the biocidal product concerned and shall without delay transmit that plan to the Commission. The use of the biocidal product with the active substance concerned shall be restricted to those Member States where the serious danger has to be prevented or, if it occurs, controlled. Or. en Article 5(2)(c) and the last subparagraph - should be voted together.)
Amendment 135 #
Council position
Article 5 – paragraph 2 – subparagraph 1 – point c
Article 5 – paragraph 2 – subparagraph 1 – point c
Amendment 135 #
Proposal for a regulation
Article 3 – paragraph 1 – point h
Article 3 – paragraph 1 – point h
(h) ‘residues’ means substances present in or on plants or products of plant origin, edible animal products, water resources drinking water or elsewhere in the environment and resulting from the use of a biocidal product, including their metabolites, breakdown or reaction products;
Amendment 137 #
Council position
Article 5 – paragraph 2 – subparagraph 2
Article 5 – paragraph 2 – subparagraph 2
Amendment 137 #
Proposal for a regulation
Article 3 – paragraph 1 – point i
Article 3 – paragraph 1 – point i
(i) ‘placing on the market’ means the first supply of a biocidal product for distribution or for use on the Community market in the course of a commercial activity, whether in return for payment or free of chargesupplying or making available biocidal products, whether in return for payment or free of charge, to a third party, import shall be deemed to be placing on the market;
Amendment 139 #
Council position
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
Amendment 140 #
Proposal for a regulation
Article 3 – paragraph 1 – point p
Article 3 – paragraph 1 – point p
(p) ‘frame formulation’ means a group of low-risk biocidal products having similar uses and presenting limited variations in their composition with regard to a reference biocidal product belonging to that group which contains the same active substances of the same specifications where such permitted variations do not adversely affect the level of risk or the efficacy of these products; where the variation is a reduction in the percentage of the active substance and/or a change in percentage composition of one or more of the non-active substances;
Amendment 143 #
Proposal for a regulation
Article 3 – paragraph 1 – point u a (new)
Article 3 – paragraph 1 – point u a (new)
ua. ‘Vulnerable Groups’ means persons needing specific consideration when assessing the acute and chronic health effects of biocide products. These include pregnant and nursing women, the unborn, infants and children, the elderly and workers and residents subject to high biocide exposure over the long term;
Amendment 151 #
Council position
Article 10 – paragraph 1 – point c a (new)
Article 10 – paragraph 1 – point c a (new)
Amendment 156 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Amendment 165 #
Council position
Article 17 – paragraph 6
Article 17 – paragraph 6
6. The authorisation holder shall notifysubmit an application to each competent authority that has granted a national authorisation for a biocidal product family of each product within the biocidal product family before placing it on the market, except where a particular product is explicitly identified in the authorisation or the variation in composition concerns only pigments, perfumes and dyes within the permitted variations. The notification shall indicate the exact composition, trade name and suffix to the authorisation number. In the case of a Union authorisation, the authorisation holder shall notify the Agency and the Commission.
Amendment 167 #
Council position
Article 18 – paragraph 1 – point e a (new)
Article 18 – paragraph 1 – point e a (new)
Amendment 171 #
Council position
Article 18 – paragraph 5
Article 18 – paragraph 5
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 notwhere it is shown by evidence that the biocidal product is necessary to prevent or control a serious danger to public or animal health or to the environment, to food and feed or to the public interest and that there are no effective alternative products or technologies available. The use of any biocidal product authorised pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment is minimised. A Member State authorising thea biocidal product would result in disproportionate negative impacts for society when compared to the risks to human or animal health or to the environment arising from tauthorised pursuant to this paragraph shall draw up a substitution plan concerning the control of the serious danger by other means including non- chemical methods, which are as effective as the biocidal product concerned and shall without delay transmit that plan to the Commission. The use of theany biocidal product under the conditions laid down in the authorisationauthorised pursuant to this paragraph shall be restricted to those Member States where the serious danger has to be prevented or, if it occurs, controlled.
Amendment 178 #
Council position
Article 19 – paragraph 2 a (new)
Article 19 – paragraph 2 a (new)
2 a. For applications for Union authorisations submitted under Article 42, the summary of the characteristics of the biocidal product referred to in point (ii) of paragraph(1)(a) of this Article shall be provided in one official language of the Union accepted by the evaluating competent authority at the time of application. The Agency shall transmit that summary to the Commission in all official languages within 30 days of the submission of the opinion referred to in Article 43(3).
Amendment 178 #
Proposal for a regulation
Article 5 – paragraph 2 – point d a (new)
Article 5 – paragraph 2 – point d a (new)
da) substances on the list of priority hazardous substances for water policy annexed to Directive 2000/60/EC.
Amendment 182 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1 – point b a (new)
Article 6 – paragraph 1 – subparagraph 1 – point b a (new)
ba) a dossier for emission scenarios of biocides based on Annex II, 1 and Annex III, 1
Amendment 185 #
Proposal for a regulation
Article 6 – paragraph 2 – point c
Article 6 – paragraph 2 – point c
Amendment 192 #
Council position
Article 24 – paragraph 1 – point b a (new)
Article 24 – paragraph 1 – point b a (new)
Amendment 195 #
Council position
Article 26 – paragraph 1
Article 26 – paragraph 1
1. A biocidal product authorised in accordance with Article 25 may be made availableIf an authorisation holder wishes to place the biocidal product on the market in allother Member States without the need for mutual recognition. However, the authorisation holder shall notify each Member State before placing the biocidal product on the market within the territory of that Member State and shall use the offithey shall apply for an Union authorisation to the Agency. The application shall contain the evaluation and authorisation already given in one Member State, including the confirmation according to article 41 that the biocidal product would have similar conditions of use across the Union. On receipt of an application for authorisation for a product already authorised according to Article 25, the Agency shall prepare an opinion on the authorisation of the biocidal language or languages of that Member State in the product's labelling, unless that Member State provides otherwise.product and submit it to the Commission. The opinion shall contain at least the following elements: (a) a statement on whether the conditions laid down in Article 24 are fulfilled b) where relevant, details of any terms or conditions which should be imposed on the placing on the market or use of the biocidal product; (c) the final assessment report on the biocidal product
Amendment 196 #
Council position
Article 26 – paragraph 2 – subparagraph 1
Article 26 – paragraph 2 – subparagraph 1
Amendment 197 #
Council position
Article 26 – paragraph 2 – subparagraph 2
Article 26 – paragraph 2 – subparagraph 2
Amendment 199 #
Proposal for a regulation
Article 9 – paragraph 1 – point b
Article 9 – paragraph 1 – point b
b) it meets twoone of the criteria to be considered as a persistent, bio- accumulative and toxic substance as set out in Annex XIII of Regulation (EC) No 1907/2006;
Amendment 206 #
Proposal for a regulation
Article 9 – paragraph 1 – point e
Article 9 – paragraph 1 – point e
e) it is classified or meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as respiratory sensitizers, carcinogen category 1A or 1B, mutagen category 1A or 1B or toxic for reproduction category 1A or 1B;
Amendment 209 #
Proposal for a regulation
Article 9 – paragraph 1 – point f
Article 9 – paragraph 1 – point f
f) it is considered to have endocrine disrupting properties that may cause adverse effect on humans or the environment on the basis of the assessment of Community or internationally agreed test guidelines or other available data.
Amendment 212 #
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. By way of derogation from Article 10(3), the inclusion of an active substance in Annex I that is considered as a candidate for substitution shall be renewed for a period not exceeding ten yearfive years. Member states shall establish and implement a substitution plan in order to ensure that the application of the active substance concerned will be phased out within the authorisation period and that the active substance can be replaced with sound chemical or non-chemical alternatives.
Amendment 213 #
Council position
Article 36 – title
Article 36 – title
Derogations from mutual recognition
Amendment 214 #
Council position
Article 36 – paragraph 1 – subparagraph 1 – introductory part
Article 36 – paragraph 1 – subparagraph 1 – introductory part
By way of derogation from Article 31(2s 26, 31(2) and 41(1), 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:
Amendment 215 #
Council position
Article 36 – paragraph 1 – subparagraph 1 – introductory part
Article 36 – paragraph 1 – subparagraph 1 – introductory part
By way of derogation from Article 31(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: Or. en (Amendment to be coherent with amendment 342 from first reading.)
Amendment 216 #
Council position
Article 36 – paragraph 1 – subparagraph 1 – point c
Article 36 – paragraph 1 – subparagraph 1 – point c
(c) the protection of health and life of humans, animals or plants; particularly of vulnerable groups, or of animals or plants; Or. en (Partial reinstatement of amendment 343 from first reading)
Amendment 216 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The Commission shall renew the inclusion of an active substance in Annex I if the active substance still complies with the requirements referred to in Article 4 and Article 5.
Amendment 218 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Unless otherwisestricter specified in the decision to renew the inclusion of an active substance in Annex I, the renewal shall be for an unlimited period of timemay be renewed for a period not exceeding 10 years.
Amendment 219 #
Council position
Article 36 – paragraph 1 – subparagraph 2
Article 36 – paragraph 1 – subparagraph 2
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 10(1) applies.
Amendment 220 #
Council position
Article 36 – paragraph 1 – subparagraph 2
Article 36 – paragraph 1 – subparagraph 2
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 10(1) applies. Or. en (Amendment to be coherent with amendment 342 from first reading.)
Amendment 221 #
Council position
Article 36 – paragraph 2 – subparagraph 1
Article 36 – paragraph 2 – subparagraph 1
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 derogwithout delay inform the other Member States and the Commission of any decision taken in this respects and its justification.
Amendment 222 #
Council position
Article 36 – paragraph 2 – subparagraph 2 – introductory part
Article 36 – paragraph 2 – subparagraph 2 – introductory part
Amendment 222 #
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1
Article 13 – paragraph 1 – subparagraph 1
1. The Commission may review the inclusion of an active substance in Annex I at any time where there are serious indications that any of the requirements referred to inin Article 4 and Article 45 are no longer complied with. Where those indications are confirmed, the Commission shall adopt a decision amending the inclusion of an active substance in Annex I or removing it from that Annex.
Amendment 223 #
Council position
Article 36 – paragraph 2 – subparagraph 2 – introductory part
Article 36 – paragraph 2 – subparagraph 2 – introductory part
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 without delay inform othe Commission. In that case, the Commission: (Reinstatement of amendment 342 from first reading. Linked to the deletion of the rest of thisr Member States and the Commission of any decision taken in this respect and its justification. Or. en paragraph)
Amendment 224 #
Council position
Article 36 – paragraph 2 – subparagraph 2 – point a
Article 36 – paragraph 2 – subparagraph 2 – point a
Amendment 225 #
Council position
Article 36 – paragraph 2 – subparagraph 2 – point a
Article 36 – paragraph 2 – subparagraph 2 – point a
Amendment 226 #
Council position
Article 36 – paragraph 2 – subparagraph 2 – point b
Article 36 – paragraph 2 – subparagraph 2 – point b
Amendment 227 #
Council position
Article 36 – paragraph 2 – subparagraph 2 – point b
Article 36 – paragraph 2 – subparagraph 2 – point b
Amendment 228 #
Council position
Article 36 – paragraph 2 – subparagraph 3
Article 36 – paragraph 2 – subparagraph 3
Amendment 229 #
Council position
Article 36 – paragraph 2 – subparagraph 3
Article 36 – paragraph 2 – subparagraph 3
Amendment 230 #
Council position
Article 36 – paragraph 2 – subparagraph 4
Article 36 – paragraph 2 – subparagraph 4
Amendment 233 #
Proposal for a regulation
Article 15 – paragraph 5 – subparagraph 2 a (new)
Article 15 – paragraph 5 – subparagraph 2 a (new)
Mandatory measures shall be established and implemented with a Framework Directive for Community action in order to achieve the sustainable professional use of biocides including the introduction of National Action Plans, integrated pest management, risk reduction measures and the promotion of alternatives. Two years after the adoption of this Regulation, the Commission shall submit a proposal to the European Parliament and the Council.
Amendment 235 #
Council position
Article 41 – paragraph 1 – introductory part
Article 41 – paragraph 1 – introductory part
1. Applicants may apply for Union authorisation for biocidal products which have similar conditions of use across the Union and which fall within the following categories of biocidal products: (Partial reinstatement of amendment of am 359 from first reading , except any product that contains active substances that fall under Article 5 or 10: Or. en view to find a modified way with acompromise with Council.)
Amendment 236 #
Council position
Article 41 – paragraph 1 – subparagraphs 1a and 1b (new)
Article 41 – paragraph 1 – subparagraphs 1a and 1b (new)
A product shall be considered a biocidal product with similar use conditions if all of the following criteria are met. The biocidal product: (i) has similar conditions of use across the European Union, according to use instructions, (ii) does not require personal protective equipment in conditions of use under their normal and realistic worst case condition of use according to Annex VI and (iii) does not contain any substances of concern. A Union authorisation may not be granted for biocidal products that contain active substances that fall under Article 5 or 10.
Amendment 239 #
Council position
Article 41 – paragraph 2 a (new)
Article 41 – paragraph 2 a (new)
Amendment 243 #
Proposal for a regulation
Article 16 – paragraph 1 – point c
Article 16 – paragraph 1 – point c
c) the nature, the quantity and the technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant impurities and non-active substances, and its metabolites and residues of toxicological or environmental significance, which result from uses to be authorised, canshould be determined according to the relevant requirements in Annexes II and III;
Amendment 244 #
Council position
Article 43 – paragraph 3 a (new)
Article 43 – paragraph 3 a (new)
3 a. Within 30 days of the submission of its opinion to the Commission, the Agency shall transmit, in all the official languages of the European Union, the draft summary of the biocidal product characteristics, as referred to in Article 21(2), as applicable;
Amendment 245 #
Council position
Article 43 – paragraph 4 – subparagraph 2
Article 43 – paragraph 4 – subparagraph 2
Amendment 246 #
Proposal for a regulation
Article 16 – paragraph 3
Article 16 – paragraph 3
3. An authorisation to place a low-risk biocidal product on the market can only be granted if the active substances are evaluated as low-risk active substances and included in Annex I (or a separate annex) in accordance with Article 4 and Article 5, further the authorisation shall be subject to compliance with the requirements of points (a), (b), (c) and (d) of paragraph 1.
Amendment 249 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 1 - introductory part
Article 17 – paragraph 1 – subparagraph 1 - introductory part
1. A biocidal product shall be considered a low-risk biocidal product if the active substances therein are included in Annex I and if both the following conditions are fulfilled:
Amendment 250 #
Council position
Article 53 – paragraph 1
Article 53 – paragraph 1
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 in the correct format and pay the applicable fee in accordance with Article 79(1).
Amendment 251 #
Council position
Article 53 – paragraph 2 a (new)
Article 53 – paragraph 2 a (new)
2 a. In the case where the Agency decides that the application has not been submitted in the correct format or that the appropriate fee has not been paid it shall reject the application and inform the applicant accordingly.
Amendment 251 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 1 - point b a (new)
Article 17 – paragraph 1 – subparagraph 1 - point b a (new)
ba) the cumulative effects of both active substances and non-active substances are taken into consideration and defined as low-risk.
Amendment 254 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 2 – point a
Article 17 – paragraph 1 – subparagraph 2 – point a
a) it contains one or more active substances which fulfil the criteria for being a POP, persistent, bio-accumulative and toxic (PBT, vP) or very persistent and very bio- accumulative (vPvB) in accordance with Annex XIII of Regulation (EC) No 1907/2006;
Amendment 256 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 2 – point b
Article 17 – paragraph 1 – subparagraph 2 – point b
b) it contains one or more activeany substances qualified as endocrine disrupters;
Amendment 259 #
Council position
Article 57 – paragraph 3 – introductory part
Article 57 – paragraph 3 – introductory part
3. Where the release of the active substances contained in the biocidal products with which a treated article was treated or which it incorporates, is intended or expected under normal or reasonably foreseeable conditions of use, or where the active substance contained in the biocidal product with which a treated article was treated, or which it incorporates, is classified or meets the criteria for classification in accordance with Regulation (EC) No 1272/2008, or meets the criteria of Article 5(1)(d) or (e), the person responsible for the placing on the market of that treated article shall ensure that the label provides the following information: Or. en (Attempt to find a compromise between Council and Parliament.)
Amendment 260 #
Council position
Article 57 – paragraph 3 – point c a (new)
Article 57 – paragraph 3 – point c a (new)
Amendment 260 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 2 – point c – subpoint vi a (new)
Article 17 – paragraph 1 – subparagraph 2 – point c – subpoint vi a (new)
via) corrosive;
Amendment 262 #
Council position
Article 57 – paragraph 4
Article 57 – paragraph 4
Amendment 265 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 2 – point c a (new)
Article 17 – paragraph 1 – subparagraph 2 – point c a (new)
ca) Product is classified or is to be classified in any category according to Regulation (EC) 1272/2008;
Amendment 266 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 2 – point c b (new)
Article 17 – paragraph 1 – subparagraph 2 – point c b (new)
cb) it contains any substance of concern.
Amendment 268 #
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 273 #
Proposal for a regulation
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
c) for other than low-risk biocidal products, a dossier or a letter of access to a dossier satisfying the requirements set out in Annex II for each active substance in the biocidal product;
Amendment 274 #
Proposal for a regulation
Article 18 – paragraph 1 – point d
Article 18 – paragraph 1 – point d
d) for low-risk biocidal products, any relevant information in support of the conclusion that the biocidal product is to be considered a low-risk biocidal product dossier or letter of access for the biocidal product satisfying the requirements set out in Annex III.
Amendment 276 #
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
Amendment 277 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 1
Article 19 – paragraph 2 – subparagraph 1
Amendment 279 #
Council position
Article 64 – paragraph 4 a (new)
Article 64 – paragraph 4 a (new)
Amendment 280 #
Proposal for a regulation
Article 20 – paragraph 2 – point o a (new)
Article 20 – paragraph 2 – point o a (new)
oa) analytical methods including recovery rates and the limits of determination (LOD) for toxicologically and ecotoxicologically relevant components of biocidal products and/or residues hereof.
Amendment 289 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. The receiving competent authority or, in the case of evaluation of an application for a Community authorisation, the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for an authorisation or a renewal of an authorisation of a biocidal product containing an active substance or non- active substance that is a candidate for substitution in accordance with Article 9(1).
Amendment 290 #
Council position
Article 65 – paragraph 4 a (new)
Article 65 – paragraph 4 a (new)
4 a. The request shall be accompanied by a fee in accordance with Article 79(1). If the fee is not paid, the request shall not be considered.
Amendment 298 #
Council position
Article 68 – paragraph 2 – subparagraph 1 – point aa (new)
Article 68 – paragraph 2 – subparagraph 1 – point aa (new)
Amendment 303 #
Council position
Article 79 – paragraph 1 – subparagraph 1 – point a
Article 79 – paragraph 1 – subparagraph 1 – point a
(a) the fees payable to the Agency, including an annual and a submission fee;
Amendment 306 #
Proposal for a regulation
Article 21 – paragraph 4
Article 21 – paragraph 4
4. By way of derogation from paragraph 1, a biocidal product containing an active substance that is a candidate for substitution shall be authorised without comparative assessment in cases where it is necessary to acquire experience first through using thatan alternative product in practice.
Amendment 308 #
Proposal for a regulation
Article 21 – paragraph 6 - subparagraph 1a (new)
Article 21 – paragraph 6 - subparagraph 1a (new)
Member States shall establish and implement a substitution plan in order to ensure that the application of the relevant biocidal product will be phased out within the authorisation period and that the relevant active substance or product can be replaced with chemical or non- chemical sound alternatives.
Amendment 312 #
Council position
Article 89 – paragraph 2 – subparagraph 1
Article 89 – paragraph 2 – subparagraph 1
Amendment 318 #
Council position
Annex II – point 5
Annex II – point 5
5. Tests submitted for the purpose of authorisation shall be conducted according to the methods described in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)66 . Methods listed in Annex I do not cover nanomaterials, except where specifically mentioned. However, if a method is inappropriate or not described, other methods shall be used which are, whenever possible, internationally recognised and must be justified in the application. scientifically satisfactory and the validity of which must be justified in the application. Or. en (Reinstatement of amendment 346 from first reading)
Amendment 319 #
Council position
Annex II – Title 1 – 7.5. – Column 1
Annex II – Title 1 – 7.5. – Column 1
7.5. Likely tonnage to be placed on the market per year and where relevant, for the envisaged major use categories.
Amendment 327 #
Council position
Annex II – Title 1 – 8.13. – Column 1 – paragraph 1a (new)
Annex II – Title 1 – 8.13. – Column 1 – paragraph 1a (new)
Other available data: Available data from emerging methods and models, including toxicity pathway-based risk assessment, in vitro and ‘omic (genomic, proteomic, metabolomic, etc.) studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening shall be submitted in parallel.
Amendment 330 #
Proposal for a regulation
Article 31
Article 31
By way of derogation from Articles 25 and 28-29, competent authorities of Member States may refuse mutual recognition of national authorisations granted for product types 15, 17 and 23 of Annex V provided that such a refusal can be justified on grounds of the protection of health of humans, environment, animals or plants, the protection of national treasures possessing artistic, historic or archaeological value, or the protection of industrial and commercial property. Competent authorities of Member States shall without delay inform each other and the Commission of any decision taken in this respect and shall indicate the reasons thereof.
Amendment 333 #
Proposal for a regulation
Article 33 – paragraph 1 – point a
Article 33 – paragraph 1 – point a
Amendment 337 #
Council position
Annex III – point 5
Annex III – point 5
5. Tests submitted for the purpose of authorisation shall be conducted according to the methods described in Regulation (EC) No 440/2008. Methods listed in Annex I do not cover nanomaterials, except where specifically mentioned. However, if a method is inappropriate or not described, other methods shall be used which are, whenever possible, internationally recognised and scientifically appropriate and must be justified in the application. scientifically satisfactory and the validity of which must be justified in the application Or. en (Reinstatement of amendment 293 from first reading.)
Amendment 339 #
Council position
Annex III – Title 1 – 7.5. – Column 1
Annex III – Title 1 – 7.5. – Column 1
7.5 Likely tonnage to be placed on the market per year and where relevant, for different use categories.
Amendment 339 #
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
Amendment 347 #
Proposal for a regulation
Article 35 - paragraph 4 - subparagraph 2
Article 35 - paragraph 4 - subparagraph 2
The Commission may, on the request of a Member State, decide that the Community authorisation shall not apply in the territory of that Member StateMember State shall notify the Commission if it restrict or prohibit the Community authorisation for a biocidal product of the product-types 15, 17 or 23 of Annex V provided that such a request canin the territory of that Member State. This must be justified on grounds of the protection of either (a) health of humans, animals or plaparticularly vulnerable groups, or (b) environments, the protection ofparticularly vulnerable ecosystems, or (c) animals, or (d) plants, or (e) national treasures possessing artistic, historic or archaeological value, or (f) the protection of industrial and commercial property.
Amendment 348 #
Proposal for a regulation
Article 35 - paragraph 4 - subparagraph 3
Article 35 - paragraph 4 - subparagraph 3
The Commission may, on the request of a Member State,Member States shall inform the Commission if it is decided that certain conditions of the Community authorisation should be adjusted to the different local circumstances in that Member State in accordance with Article 29.
Amendment 352 #
Proposal for a regulation
Article 35 - paragraph 5
Article 35 - paragraph 5
(5) If the decision referred to in paragraph 4 refuses to grant a Community authorisation to a biocidal product because it does not fulfil the criteria for a low-risk biocidal product in accordance with Article 17, the applicant may apply, if relevant, for a Community authorisation in accordance with point (a) of Article 33(1) or a national authorisation in accordance with Chapter V.
Amendment 354 #
Council position
Annex VI – Assessment – point 47 a (new)
Annex VI – Assessment – point 47 a (new)
Amendment 356 #
Proposal for a regulation
Article 39 - paragraph 1 - point a
Article 39 - paragraph 1 - point a
(a) the requirements referred to in Article 16 are not satisfied or pursuant to Community standards for the protection of human health and the environment, particularly established in accordance with Directive 2008/56/EC, Directive 2006/118/EC, Directive 2000/60/EC, Directives 98/83/EC and 96/61/EC;
Amendment 376 #
Proposal for a regulation
Article 45 - paragraph 1 - subparagraph 1
Article 45 - paragraph 1 - subparagraph 1
(1) By way of derogation from Articles 15 and 16, a competent authority may authorise for a period not exceeding ninefour months, the placing on the market of a biocidal product not complying with the provisions of this Regulation for a limited and controlled use if all of the following conditions are met: (a) such a measure is necessary because of a danger to public health or the environment which cannot be contained by other means. and (b) the active substances concerned are approved for inclusion into Annex I or evaluated according to Article 4 of this Regulation and a full dossier is provided (c) if the relevant active substances are classified as cut-off substances or candidates for substitution, a mandatory substitution plan is established and implemented by the applicant or competent authority in order to replace the relevant substances with non- hazardous chemical or non-chemical alternatives within 2 years after approval and (d) the application of the product is restricted to professional users who are certified pursuant to the requirements for an integrated pest management and the use is appropriately monitored .
Amendment 378 #
Proposal for a regulation
Article 45 - paragraph 2
Article 45 - paragraph 2
Amendment 427 #
Proposal for a regulation
Article 55 - paragraph 2 - point b
Article 55 - paragraph 2 - point b
Amendment 434 #
Proposal for a regulation
Article 57 - paragraph 1
Article 57 - paragraph 1
(1) Producers, importers and professional users of biocidal products shall keep records of the biocidal products they produce, place on the market oruse, containing the name of the biocide, the time and the dose of application, the area and the articles and materials where the biocide was used, for at least three years. They shall make available the relevant information contained in these records available to the competent authority on request. Third parties such as the drinking water industry, retailers or residents, may request access to this information by addressing the competent authority. Producers of biocidal products shall undertake post-authorisation monitoring on request of the competent authorities. They shall notify the competent authorities of the relevant results.
Amendment 472 #
Proposal for a regulation
Article 81
Article 81
By way of derogation from Article 47, treated articles and materials that incorporate biocidal products which are not authorised in the Community or in at least one Member State and which were available on the market on ... [OJ: insert the date referred to in the first subparagraph of Article 85] may, until the date of a decision granting authorisation to these biocidal products, continue to be placed on the market if the application for authorisation is submitted at the latest by 1 January 20173. In the case of a refusal to grant an authorisation to place a biocidal product on the market, treated articles and materials that incorporate such biocidal product shall no longer be placed on the market within six months after such decision.
Amendment 480 #
Proposal for a regulation
Annex II – heading 1 – point 1
Annex II – heading 1 – point 1
(1) Dossiers on active substances shall contain the information needed to establish, where relevant, that exposure is below the Threshold of Toxicological Concern (TTC), or where relevant, to establish the Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL), Predicted Environmental Concentration (PEC) and Predicted No-Effect Concentration (PNEC).
Amendment 482 #
Proposal for a regulation
Annex II – heading 1 – paragraph 4
Annex II – heading 1 – paragraph 4
(4) Tests submitted for the purpose of authorisation shall be conducted according to the methods described in Council Regulation (EC) No 440/2008. However, if a method is inappropriate or not described, other methods shall be used which are, whenever possible, internationally recognised scientifically appropriate and must be justified in the application.
Amendment 483 #
Proposal for a regulation
Annex II – title 1 - paragraph 4
Annex II – title 1 - paragraph 4
Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on intelligent testing strategies should be consultedsought from experts in alternatives to animal experimentation in addition to this Annex.
Amendment 496 #
Proposal for a regulation
Annex II -title 1 - table - section 6.6.1
Annex II -title 1 - table - section 6.6.1
6.6.1. The short-term toxicity study (28 days) does not need to be conducted if: – a reliable sub-chronic (90 days) or chronic toxicity study is available, provided that an appropriate species, dosage, solvent and route of administration were used; or – where a substance undergoes immediate disintegration and there are sufficient data on the cleavage products; or – relevant human exposure can be excluded in accordance with Annex IV section 3 The appropriate route shall be chosen on the following basis: Testing by the dermal route is appropriate if: (1) inhalation of the substance is unlikely; and (2) skin contact in production and/or use is likely; and (3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin. Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The sub-chronic toxicity study (90 days) (Tier II, section 6.6.2) shall be proposed by the applicant if: the frequency and duration of human exposure indicates that a longer term study is appropriate; and one of the following conditions is met: – other available data indicate that the substance may have a dangerous property that cannot be detected in a short-term toxicity study; or – appropriately designed toxicokinetic studies reveal accumulation of the substance or its metabolites in certain tissues or organs which would possibly remain undetected in a short term toxicity study but which are liable to result in adverse effects after prolonged exposure. Further studies shall be proposed by the applicant or may be required in case of: – failure to identify a NOAEL in the 28 or the 90 days study, unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects; or – toxicity of particular concern (e.g. serious/severe effects); or – indications of an effect for which the available evidence is inadequate for toxicological and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity); or – the route of exposure used in the initial repeated dose study was inappropriate in relation to the expected route of human exposure and route-to-route extrapolation cannot be made; or – particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity to humans may be expected); or – effects shown in substances with a clear relationship in molecular structure with the substance being studied, were not detected in the 28 or the 90 days study– a reliable sub-chronic (90 days) or chronic toxicity study is available or planned, provided that an appropriate species, dosage, solvent and route of administration were or are to be used; or – where a substance undergoes immediate disintegration and there are sufficient data on the cleavage products; or – relevant human exposure can be excluded in accordance with Annex IV section 3. Testing shall be conducted via the oral route unless: (1) the primary route of human exposure will be dermal, and one of the following conditions is met: - the physicochemical and toxicological properties, including an in-vitro dermal penetration study (i.e. OECD TG 428), indicate that dermal bioavailability will be substantial; or - significant dermal toxicity or dermal penetration is recognised for structurally related substances. (2) the primary route of human exposure will be inhalation, taking into account the vapour pressure of the substance and likely frequency, magnitude and duration of exposure to aerosols, particles or droplets of an inhalable size. Testing shall only be carried out via one exposure route. Estimates of toxicity via other routes shall be based upon pharmacokinetic modelling. The sub-chronic toxicity study (90 days) (Tier II, section 6.6.2) shall be proposed by the applicant in lieu of a 28-day study if: the frequency and duration of human exposure indicates that a study of > 1 month and < 12 months is appropriate and available data indicate that the kinetics or other properties of a substance or its metabolites are such that adverse effects could go undetected in a short-term toxicity study For substances related on a molecular level to known organ-specific toxicants (e.g. neurotoxicity), additional relevant parameters should ideally be examined in the context of a 28-day or 90-day study in lieu of a stand-alone, e.g. neurotoxicity study. Further stand-alone studies should be limited to exceptional circumstances.
Amendment 497 #
Proposal for a regulation
Annex II -title 1 - table - section 6.6.2
Annex II -title 1 - table - section 6.6.2
6.6.2. The sub-chronic toxicity study (90 days) does not need to be conducted if: – a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the criteria for classifying the substance as R48, for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-90 days for the same route of exposure; or – a reliable chronic toxicity study is available, provided that an appropriate species and route of administration were used; or – a substance undergoes immediate disintegration and there are sufficient data on the cleavage products (both for systemic effects and effects at the site of uptake); or – the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day "limit test", particularly if such a pattern is coupled with limited human exposure. The appropriate route shall be chosen on the following basis: Testing byTesting shall be conducted via the dermoral route is appropriate ifunless: (1) skin contact in production and/or use is likely; and (2) the physicochemical properties suggest a significant rate of absorption through the skin; and (3) one of the following conditions is met: – toxicity is observed in the acute dermal toxicity test at lower doses than in the oral toxicity test; or – systemic effects or other evidence of absorption is observed in skin and/or eye irritation studies; or – in vitro tests indicate significant dermal absorptionthe primary route of human exposure will be dermal, and one of the following conditions is met: - the physicochemical and toxicological properties, including an in-vitro dermal penetration study (i.e. OECD TG 428), indicate that dermal bioavailability will be substantial; or –- significant dermal toxicity or dermal penetration is recognised for structurally related substances. Testing by the inhalation route is appropriate if: – exposure of humans via(2) the primary route of human exposure will be inhalation is likely, taking into account the vapour pressure of the substance and/or the possibilitylikely frequency, magnitude and duration of exposure to aerosols, particles or droplets of an inhalable size. Further studies shall be proposed by the applicant or may be required in case of: – failure to identify a NOAEL in the 90 days study unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects; or – toxicity of particular concern (e.g. serious/severe effects); or – indications of an effect for whTesting shall be carried out via one exposure route. Estimates of toxicity via other routes shall be based upon pharmacokinetic modelling. For substances related on a molecular level to known organ-specifich the available evidence is inadequate for toxicological and/or risk choxicants (e.g. neurotoxicity), additional relevant paracmeterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity); or – particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity to humans may be expected)s should ideally be examined in the context of a 28-day or 90-day study in lieu of a standalone, e.g. neurotoxicity study. Further standalone studies should be limited to exceptional circumstances.
Amendment 498 #
Proposal for a regulation
Annex II -title 1 - table - section 6.6.3
Annex II -title 1 - table - section 6.6.3
6.6.3. A long-term repeated dose toxicity study (≥12 months) may be proposed by the applicant or required ifonly if: - the frequency, magnitude and duration of human exposure, indicates that a longer term studychronic risk assessment is appropriate; and one o- if the following conditions is met: - serious or severe toxicity effects of particular concern when observed in the 28-day or 90-day study for which the available evidence is inadequate for toxicological evaluation or risk characterisation; or - effects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28-day or 90-day study; or - the substance may have a dangerous property that cannot be detected in a 90- day studyapplication of an appropriate uncertainty factor would not be sufficiently protective for risk assessment purposes. If carcinogenicity data are also required and not already available, long-term repeated dose and carcinogenicity studies should be carried out using the OECD TG 453 combination study protocol.
Amendment 499 #
Proposal for a regulation
Annex II -title 1 - table - section 6.6.4
Annex II -title 1 - table - section 6.6.4
Amendment 500 #
Proposal for a regulation
Annex II -title 1 - table - section 6.7
Annex II -title 1 - table - section 6.7
6.7. The studies need not be conducted if: – the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented; or – the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented; or –- the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure. If a substance is known to have an adverse effect on fertility, (e.g. based on testes pathology data or sperm parameters from 90-day repeated dose studies) meeting the criteria for classification as Repr Cat 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for pre-natal development toxicity must be considered. If a substance is known to cause development toxicity, meeting the criteria for classification as Repr Cat 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for development toxicity will be necessary. However, testing for effects on fertility must be considered.
Amendment 501 #
Proposal for a regulation
Annex II -title 1 - table - section 6.7.1
Annex II -title 1 - table - section 6.7.1
6.7.1. This study does not need to be conducted if: – the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented; or – the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented; or – relev–there is no significant human exposure can be excluded in accordance with Annex IV section 3; or – a pre-natal developmental toxicity study (Tier II, 6.7.2) or a one- or two-generation reproductive toxicity study (Tier II, section 6.7.3) is available. If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as Repr Cat 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for pre-natal development toxicity must be considered. If a substance is known to cause developmental toxicity, meeting the criteria for classification as Repr Cat 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered. In cases where there are serious concerns about the potential for adverse effects on fertility or development, either a pre-natal developmental toxicity study (Tier II, section 6.7.2) or a two generation reproductivean enhanced one- generation reproductive toxicity study, with or without a pre-natal developmental toxicity studymodule (Tier II, section 6.7.3), may be proposed by the applicant instead of the screening study.
Amendment 512 #
Proposal for a regulation
Annex II -title 1 - table - section 11.1 a (new)
Annex II -title 1 - table - section 11.1 a (new)
11.1a. Avian toxicity data shall not be required unless the use profile for a substance indicates significant potential for exposure or harmful effects to birds.
Amendment 515 #
Proposal for a regulation
Annex II -title 1 - table - section 11.1.3 a (new)
Annex II -title 1 - table - section 11.1.3 a (new)
11.1.3 This test is not required if the dietary toxicity study (section 11.1.2) shows that the LC50 is above 2,000 mg/kg.
Amendment 517 #
Proposal for a regulation
Annex II -title 1 - table - section 12
Annex II -title 1 - table - section 12
Amendment 518 #
Proposal for a regulation
Annex II – title 2 – point 5.2.1 – paragraph 1(new)
Annex II – title 2 – point 5.2.1 – paragraph 1(new)
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 reduced Murine Local Lymph Node Assay (rLLNA) is the first-choice method for in vivo testing as a screening test to distinguish between sensitisers and non sensitisers. The full LLNA should be performed when it is known that an assessment of sensitisation potency is required. Only in exceptional circumstances should another test be used, in which case a justification shall be provided.
Amendment 519 #
Proposal for a regulation
Annex II – title 2 – point 5.2.2 – paragraph 1 (new)
Annex II – title 2 – point 5.2.2 – paragraph 1 (new)
Testing shall be conducted via the oral route unless the primary route of human exposure is expected to be inhalation. Testing shall be carried out via only a single exposure route.
Amendment 520 #
Proposal for a regulation
Annex II – title 2 – point 5.2.2.2 – paragraph 1 (new)
Annex II – title 2 – point 5.2.2.2 – paragraph 1 (new)
Testing by the inhalation route is appropriate only if this constitutes the primary route of human exposure.
Amendment 521 #
Proposal for a regulation
Annex II – title 2 – point 5.2.2.3
Annex II – title 2 – point 5.2.2.3
Amendment 522 #
Proposal for a regulation
Annex II – title 2 – point 5.2.5 – paragraph 1 (new)
Annex II – title 2 – point 5.2.5 – paragraph 1 (new)
Testing shall be conducted via the oral route unless the primary route of exposure is expected to be inhalation. Testing shall be carried out via only a single exposure route.
Amendment 523 #
Proposal for a regulation
Annex II – title 2 – point 5.2.5.1 – paragraph 1 (new)
Annex II – title 2 – point 5.2.5.1 – paragraph 1 (new)
Testing by the inhalation route is appropriate only if this constitutes the primary route of human exposure.
Amendment 524 #
Proposal for a regulation
Annex II – title 2 – point 5.3 – paragraph 1 (new)
Annex II – title 2 – point 5.3 – paragraph 1 (new)
Testing may be waived if there is no evidence of specific toxicity in earlier studies.
Amendment 525 #
Proposal for a regulation
Annex II – title 2 – point 5.4 – paragraph 1 (new)
Annex II – title 2 – point 5.4 – paragraph 1 (new)
For new substances, it should be possible to assess the parameters of an in-vivo micronucleus test as part of a repeated exposure study.
Amendment 526 #
Proposal for a regulation
Annex II – title 2 – point 5.5 – paragraph 1 (new)
Annex II – title 2 – point 5.5 – paragraph 1 (new)
Testing may be waived if there is no evidence of genotoxicity in somatic cell studies.
Amendment 527 #
Proposal for a regulation
Annex II – title 2 – point 8.1 – paragraphs 1 and 2(new)
Annex II – title 2 – point 8.1 – paragraphs 1 and 2(new)
An avian dietary toxicity study in a single species may be proposed where a substance use profile indicates the potential for significant exposure to birds. An avian reproduction study is not generally required, and is not appropriate if the dietary toxicity study (section 8.1.1.) shows that the LC50 is above 5,000 mg/kg.
Amendment 528 #
Proposal for a regulation
Annex II – title 2 – point 8.2.1 – paragraph 1 (new)
Annex II – title 2 – point 8.2.1 – paragraph 1 (new)
Requirements for aquatic toxicity testing on vertebrate animals may be waived if the use profile for a substance does not indicate significant potential for exposure to the aquatic environment.
Amendment 529 #
Proposal for a regulation
Annex II – title 2 – point 8.7.2
Annex II – title 2 – point 8.7.2
Amendment 530 #
Proposal for a regulation
Annex III – heading 1 – paragraph 1
Annex III – heading 1 – paragraph 1
1. Dossiers on biocidal products shall contain the information needed to establish, that exposure is below the Threshold of Toxicological Concern (TTC), or where relevant, to establish Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL), Predicted Environmental Concentration (PEC), and Predicted No- Effect Concentration (PNEC).
Amendment 532 #
Proposal for a regulation
Annex III – heading 1 – paragraph 5
Annex III – heading 1 – paragraph 5
5. Tests submitted for the purpose of authorisation shall be conducted according to the methods described in Council Regulation (EC) No 440/2008. However, if a method is inappropriate or not described, other methods shall be used which are, whenever possible, internationally recognised scientifically satisfactory and must be justified in the application.
Amendment 533 #
Proposal for a regulation
Annex III – heading 1 – paragraph 7
Annex III – heading 1 – paragraph 7
7. Where testing is done, a detailed description (specification) of the material used and its impurities must be provided. Where necessary, data as established in Annex II shall be required for all the toxicologically/eco-toxicologically relevant chemical components of the biocidal product, in particular if the components are substances of concern as defined in Article 3.
Amendment 534 #
Proposal for a regulation
Annex III – heading 1 – paragraph 8
Annex III – heading 1 – paragraph 8
8. Where test data exist that have been generated before ... [OJ: insert the date referred to in the first subparagraph of Article 85] by methods other than those laid down in Regulation (EC) No 440/2008, the adequacy of such data for the purposes of this Regulation and the need to conduct new tests according to the Regulation (EC) No 440/2008 must be decided by the competent authority of the Member State concerned in agreement with the ECHA, on a case-by-case basis, taking into account, among other factors, the need to minimise testing on vertebrate animals.
Amendment 536 #
Proposal for a regulation
Annex III – title 1 – point 6.1
Annex III – title 1 – point 6.1
For studies of Sections 6.1.1 to 6.1.3, biocidal products other than gases shall be administered via at least two routes, one of which should be the oral route. The choice of the second route will dependclassification by calculation should be the default approach. Only in exceptional cases should additional in-vivo testing be considered, and in such cases, only the nature of the product and the likely route of human exposuresingle most relevant exposure route should be tested. Gases and volatile liquids should be administered by the inhalation route.
Amendment 537 #
Proposal for a regulation
Annex III – title 1 – point 6.1.2
Annex III – title 1 – point 6.1.2
Amendment 538 #
Proposal for a regulation
Annex III – title 1 – point 6.1.3 – paragraph 1 (new)
Annex III – title 1 – point 6.1.3 – paragraph 1 (new)
Testing by the inhalation route is appropriate only if (i) classification by calculation is not feasible and (ii) this constitutes the primary route of human exposure, taking into account the vapour pressure of the substance and the possibility of exposure to aerosols, particles or droplets of an inhalable size. The Acute Toxic Class Method is the first- choice method for in-vivo testing. Only in exceptional circumstances should the classic “lethal concentration” (LC50) test be used. Justification for the use of another test shall be provided.
Amendment 539 #
Proposal for a regulation
Annex III – title 1 – point 6.1.4
Annex III – title 1 – point 6.1.4
Amendment 540 #
Proposal for a regulation
Annex III – title 1 – point 6.2 – paragraph 1 (new)
Annex III – title 1 – point 6.2 – paragraph 1 (new)
Classification by calculation should be the default approach.
Amendment 541 #
Proposal for a regulation
Annex III – title 1 – point 6.3 – paragraph 1 (new)
Annex III – title 1 – point 6.3 – paragraph 1 (new)
Classification by calculation should be the default approach.
Amendment 543 #
Proposal for a regulation
Annex III – title 1 – point 9.2.1
Annex III – title 1 – point 9.2.1
Amendment 545 #
Proposal for a regulation
Annex III – title 1 – point 9.3.3.1
Annex III – title 1 – point 9.3.3.1
Amendment 546 #
Proposal for a regulation
Annex III – title 2 – point 6.1.1 – paragraph 1 (new)
Annex III – title 2 – point 6.1.1 – paragraph 1 (new)
Classification by calculation should be the default approach. Only in exceptional cases should additional in-vivo testing be considered, and in such cases, only the single most relevant exposure route should be tested.
Amendment 547 #
Proposal for a regulation
Annex III – title 2 – point 6.1.2 – paragraph 1 (new)
Annex III – title 2 – point 6.1.2 – paragraph 1 (new)
Testing by the inhalation route is appropriate only if (i) classification by calculation is not feasible and (ii) this constitutes the primary route of human exposure.
Amendment 548 #
Proposal for a regulation
Annex III – title 2 – point 6.2.1 – paragraph 1 (new)
Annex III – title 2 – point 6.2.1 – paragraph 1 (new)
Classification by calculation should be the default approach.
Amendment 549 #
Proposal for a regulation
Annex III – title 2 – point 6.2.2 – paragraph 1 (new)
Annex III – title 2 – point 6.2.2 – paragraph 1 (new)
Classification by calculation should be the default approach.
Amendment 550 #
Proposal for a regulation
Annex III – title 2 – point 6.2.3 – paragraph 1 (new)
Annex III – title 2 – point 6.2.3 – paragraph 1 (new)
Classification by calculation should be the default approach.
Amendment 556 #
Proposal for a regulation
Annex IV – point 1.1.3 a (new)(new)
Annex IV – point 1.1.3 a (new)(new)
1.1.3a. Calculation methods for the evaluation of health hazards of preparations Data requirements for preparations may generally be waived in favour of the calculation approach specified in Annex II to Directive 1999/45/EC, which is applicable to all preparations and which takes into consideration all the health hazards of substances contained in the preparation. Guidance is specifically provided for the following categories of adverse health effects: - acute lethal effects - non-lethal irreversible effects after a single exposure - severe effects after repeated or prolonged exposure - corrosive or irritant effects - sensitising effects - carcinogenic effects - mutagenic effects - reprotoxic effects
Amendment 558 #
Proposal for a regulation
Annex IV – point 1.4 – paragraph 2 – point 2
Annex IV – point 1.4 – paragraph 2 – point 2
(2) results are adequate for the purpose of classification and/or labelling and risk assessment; and
Amendment 559 #
Proposal for a regulation
Annex IV – point 1.5 – paragraph 3 – indent 1
Annex IV – point 1.5 – paragraph 3 – indent 1
– be adequate for the purpose of classification and labelling and/or risk assessment,
Amendment 570 #
Proposal for a regulation
Annex VI – introduction – point 4
Annex VI – introduction – point 4
Amendment 572 #
Proposal for a regulation
Annex VI – evaluation – point 14
Annex VI – evaluation – point 14
14. A risk assessment on the active substance present in the biocidal product shall always be carried out. If there are, in addition, any substances of concern present in the biocidal product then a risk assessment shall be carried oull available data shall be included in the dossier for authorisation of a biocidal product for each of these. The risk assessmentdata shall cover the proposed normal use of the biocidal product together with a realistic worst-case scenario including any relevant production and disposal issue either of the biocidal product itself or any material treated with it.
Amendment 576 #
Proposal for a regulation
Annex VI – evaluation – point 47
Annex VI – evaluation – point 47
47. Data shall be submitted to and evaluated by the competent authorities to assess whether the biocidal product does not cause unnecessary suffering and pain in its effect on target vertebrates. This shall include an evaluation of the mechanism by which the effect is obtained and the observed effects on the behaviour and health of the target vertebrates; where the intended effect is to kill the target vertebrate the time necessary to obtain the death of the target vertebrate and the conditions under which death occurs shall be evaluated. Those findings shall for each authorised biocidal product be made publicly available on the Agency website.