Activities of Sabine WILS related to 2009/0076(COD)
Plenary speeches (1)
Placing on the market and use of biocidal products (debate)
Amendments (71)
Amendment 104 #
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 protecfirst to ensure a high level of protection of both human and animal health and the environment from any harmful or unacceptable effects linked with the use of biocides and secondly to promote the internal market of low-risk biocidal products within the Community. Particular attention should be paid to the protection of vulnerable groups of the population, in the Member States, harmonised rucluding pregnant women, infants and children. The precautionary principles should be laid down for the approval of active substances and theapplied and this Regulation should ensure that industry demonstrates that substances or products produced or placinged on the market and use of biocidal products, including the rules on the mutual recognition of audo not have any harmful effect on human or animal health orisations and on parallel trade any unacceptable effects on the environment.
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 116 #
Proposal for a regulation
Recital 26
Recital 26
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 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 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 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 137 #
Council position
Article 5 – paragraph 2 – subparagraph 2
Article 5 – paragraph 2 – subparagraph 2
Amendment 139 #
Council position
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
Amendment 151 #
Council position
Article 10 – paragraph 1 – point c a (new)
Article 10 – paragraph 1 – point c a (new)
Amendment 157 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – introductory part
Article 5 – paragraph 1 – subparagraph 1 – introductory part
1. Notwithstanding Article 4(1), active substances referred to in paragraph 2 shall be included in Annex I only if at least onell of the following conditions isare met:
Amendment 158 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point a
Article 5 – paragraph 1 – subparagraph 1 – point a
a) the exposure of humans to that active substance in a biocidal product, under normalrealistic and all worst-case conditions of use, is negligible, in particular where the product is used in closed systems or strictly controlled conditions;
Amendment 162 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point b
Article 5 – paragraph 1 – subparagraph 1 – point b
b) it is shownproven by the applicant on the basis of documented evidence that the active substance is necessary to control a serious danger to public health which cannot be contained by any other available means, including non-chemical means;
Amendment 164 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point c
Article 5 – paragraph 1 – subparagraph 1 – point c
c) it is shown that not including the active substance in Annex I would cause disproportionate negative impacts when compared with the risk to human health or the environment arising from the use of the substancewith a comparative assessment it is shown that there are no chemical or non- chemical alternative substances or technologies for the purpose concerned and which present significantly lower risk and that there are no suitable alternative substances or technologies.rm for human or animal health or the environment;
Amendment 166 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point c a (new)
Article 5 – paragraph 1 – subparagraph 1 – point c a (new)
ca. the use of the active substance is subject to risk mitigation measures to ensure that exposure to humans and the environment is minimised and regularly monitored;
Amendment 167 #
Council position
Article 18 – paragraph 1 – point e a (new)
Article 18 – paragraph 1 – point e a (new)
Amendment 167 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point c b (new)
Article 5 – paragraph 1 – subparagraph 1 – point c b (new)
cb. a substitution plan on how to control the serious danger by other means, including non-chemical methods, is presented by the applicant.
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 171 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
Amendment 172 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2 a (new)
Article 5 – paragraph 1 – subparagraph 2 a (new)
2a. The active substance shall only be included in Annex I once, for a period not exceeding five years.
Amendment 180 #
Proposal for a regulation
Article 5 – paragraph 2 – point d a (new)
Article 5 – paragraph 2 – point d a (new)
da) Active substances containing nanomaterials.
Amendment 192 #
Council position
Article 24 – paragraph 1 – point b a (new)
Article 24 – paragraph 1 – point b a (new)
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 219 #
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 unlimitednot exceeding a maximum period of time5 years.
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 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 226 #
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 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 235 #
Proposal for a regulation
Article 16 – paragraph 1 – point b – subpoint i
Article 16 – paragraph 1 – point b – subpoint i
i) it is necessary and sufficiently effective;
Amendment 236 #
Proposal for a regulation
Article 16 – paragraph 1 – point b – subpoint ii
Article 16 – paragraph 1 – point b – subpoint ii
ii) it has no unacceptablereal or potential effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates;
Amendment 238 #
Proposal for a regulation
Article 16 – paragraph 1 – point b – subpoint iii
Article 16 – paragraph 1 – point b – subpoint iii
iii) it has no unacceptablreal or potential adverse effects itself or as a result of its metabolites and residues, directly or indirectly, on humanthe health of humans, particularly of vulnerable groups, or animal health;
Amendment 239 #
Council position
Article 41 – paragraph 2 a (new)
Article 41 – paragraph 2 a (new)
Amendment 240 #
Proposal for a regulation
Article 16 – paragraph 1 – point b – subpoint iv – introductory part
Article 16 – paragraph 1 – point b – subpoint iv – introductory part
iv) it has no unacceptablreal or potential adverse effects itself, or as a result of its residues, on the environment having particular regard to the following considerations:
Amendment 241 #
Proposal for a regulation
Article 16 – paragraph 1 – point b – subpoint iv – indent 1
Article 16 – paragraph 1 – point b – subpoint iv – indent 1
- its fate and distribution in the environment including long-distance distribution;
Amendment 244 #
Proposal for a regulation
Article 16 – paragraph 2 – point a
Article 16 – paragraph 2 – point a
a) all normal conditions or other realistic scenarios like accidents under which the biocidal product may be used;
Amendment 245 #
Council position
Article 43 – paragraph 4 – subparagraph 2
Article 43 – paragraph 4 – subparagraph 2
Amendment 245 #
Proposal for a regulation
Article 16 – paragraph 2 – point c a (new)
Article 16 – paragraph 2 – point c a (new)
ca) cumulative or synergistic effects.
Amendment 247 #
Proposal for a regulation
Article 16 – paragraph 5 – point b a (new)
Article 16 – paragraph 5 – point b a (new)
ba) considered to have endocrine disrupting properties.
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 259 #
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) explosive;
Amendment 260 #
Council position
Article 57 – paragraph 3 – point c a (new)
Article 57 – paragraph 3 – point c a (new)
Amendment 261 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 1 – point c – subpoint vi b (new)
Article 17 – paragraph 1 – subparagraph 1 – point c – subpoint vi b (new)
vib)corrosive;
Amendment 262 #
Council position
Article 57 – paragraph 4
Article 57 – paragraph 4
Amendment 262 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 2 – point c – subpoint vi c(new)
Article 17 – paragraph 1 – subparagraph 2 – point c – subpoint vi c(new)
vic) very toxic or toxic.
Amendment 279 #
Council position
Article 64 – paragraph 4 a (new)
Article 64 – paragraph 4 a (new)
Amendment 298 #
Council position
Article 68 – paragraph 2 – subparagraph 1 – point aa (new)
Article 68 – paragraph 2 – subparagraph 1 – point aa (new)
Amendment 304 #
Proposal for a regulation
Article 21 – paragraph 4
Article 21 – paragraph 4
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 322 #
Council position
Annex II – Title 1 – 8.9. Repeated dose toxicity – Column 1 – point(iii)
Annex II – Title 1 – 8.9. Repeated dose toxicity – Column 1 – point(iii)
8.9 Repeated dose toxicity (iii) dermal toxicity is recognised for structurally related substances and for example is observed at lower doses than in the oral toxicity test orand dermal absorption is comparable or higher than oral absorption
Amendment 328 #
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 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 342 #
9.2. Further Ecotoxicological studies Further studies chosen from among the endpoints referred to in Annex II, Section 9 for relevant components of the biocidal product or the biocidal product itself may be required if the data on the active substance cannot give sufficient information and if there are indications of risk due to specific properties of the biocidal product. Vertebrate animal testing should be restricted to acute studies.
Amendment 554 #
Proposal for a regulation
Annex IV – title
Annex IV – title
Amendment 555 #
Proposal for a regulation
Annex IV – introductory paragraph
Annex IV – introductory paragraph
Amendment 557 #
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 labelling and/or risk assessment; and
Amendment 560 #
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 561 #
Proposal for a regulation
Annex IV – point 2
Annex IV – point 2
Amendment 562 #
Proposal for a regulation
Annex IV – point 3
Annex IV – point 3
Amendment 569 #
Proposal for a regulation
Annex VI – introduction – point 4
Annex VI – introduction – point 4
Amendment 571 #
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 575 #
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. These findings shall for each authorised biocidal product be made publicly available on the Agency website.
Amendment 578 #
Proposal for a regulation
Annex VI – decision making – point 77 – introductory part
Annex VI – decision making – point 77 – introductory part
77. The competent authorities or the Commission shall not authorise a biocidal product if the foreseeable concentration of the active substance or a substance of concern or of relevant metabolites, breakdown or reaction products to be expected in groundwater or surface water or its sediments after use of the biocidal product under the proposed conditions of use:
Amendment 579 #
Proposal for a regulation
Annex VI – decision making – point 77 – indent 2 a (new)
Annex VI – decision making – point 77 – indent 2 a (new)
– – risk a non-achievement of the objectives or standards fixed by: – Directive 98/83/EC, or –Directive 2000/60/EC or –Directive 2006/118/EC or –Directives 2008/56/EC, or –Directive 2008/105/EC, or - international agreements containing important obligations on the protection of marine waters from pollution or
Amendment 580 #
Proposal for a regulation
Annex VI – decision making – point 77 – last part
Annex VI – decision making – point 77 – last part