108 Amendments of Michèle RIVASI related to 2009/0076(COD)
Amendment 91 #
Proposal for a regulation
Article 15 – paragraph 5 – subparagraphs 2 a and 2 b (new)
Article 15 – paragraph 5 – subparagraphs 2 a and 2 b (new)
Mandatory measures shall be established and implemented by means of a Framework Directive for Union action in order to achieve the sustainable use of biocides including integrated pest management and risk reduction measures. The Commission shall submit a proposal to the European Parliament and Council not later than two years after this Regulation is adopted.
Amendment 92 #
Proposal for a regulation
Article 15 – paragraph 5 – subparagraph 2 a (new)
Article 15 – paragraph 5 – subparagraph 2 a (new)
The Commission shall submit a proposal to the European Parliament and Council not later than two years after this Regulation is adopted.
Amendment 99 #
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) it contains active substances which are not included in Annex I of this Regulation.
Amendment 104 #
Council position
Recital 13
Recital 13
(13) The active substances in the Union list should be regularly examined to take account of developments in science and technology. Where there are seriousignificant indications that an active substance used in biocidal products or treated articles does not meet the requirements of this Regulation, the Commission should be able to review the approval of the active substance. Or. en (To be coherent with parts of amendment 74 from first reading.)
Amendment 106 #
Proposal for a regulation
Recital 10
Recital 10
(10) With view to achieving a high level of environmental and human health protection, active substances with the worst hazard profiles should not be approved for use in biocidal products except in exceptional and very specific situations. These should include situations when the approval is justified because of a negligible exposure of humans to the substance, public health reasons or disproportionate negative impacts of a possible non-inclusion provided no alternatives exist or a serious danger to public that cannot be contained by any other means in that Member State. This should be subject to appropriate risk mitigation measures to minimize any exposure and to the submission of a substitution plan.
Amendment 107 #
Proposal for a regulation
Recital 11
Recital 11
(11) In order to prevent the use of active substances with the worst hazard profiles, in particular when their use is not authorised under Regulation (EC) No XXX/2009 of the European Parliament and of the Council of ..... 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, it is appropriate to restrict their approval to situations when the exposure of humans to the substance is negligible or the substance is necessary for public health reasonsto combat a serious danger to public that cannot be contained by any other means in that Member State.
Amendment 109 #
Proposal for a regulation
Recital 13
Recital 13
(13) Active substances can, on basis of their intrinsic hazardous properties, be designated as candidates for substitution with other active substances, whenever such substances considered as efficient towards the targeted harmful organisms become available in sufficient variety to avoid the development of resistances amongst harmful organisms. In order to allow for a regular examination of substances identified as candidates for substitution, the inclusion period for these substances should not, evenxceed five years, and in the case of renewal, not exceed tseven years. Furthermore, the identification of substances which are considered as candidates for substitution should be considered as a first step of a comparative assessment.
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 114 #
Council position
Article 2 – paragraph 2 – subparagraph 2
Article 2 – paragraph 2 – subparagraph 2
Amendment 115 #
Proposal for a regulation
Recital 21
Recital 21
(21) As the International Convention for the Control and Management of Ships' Ballast Water and Sediments provides for an effective assessment of the risks posed by ballast water management systems, the final approval and subsequent type approval of such systems should be considered equivalent tofor the product authorisation required under this Regulation.
Amendment 121 #
Council position
Article 3 – paragraph 1 – point (f) – subparagraph 2 – indent 1
Article 3 – paragraph 1 – point (f) – subparagraph 2 – indent 1
– a substance classified as dangerous or meeting the criteria to be classified as dangerous according to Directive 67/548/EEC, and present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Articles 5, 6 and 7 of Directive 1999/45/EC, or Or. en (Reinstatement of the Commission text.)
Amendment 122 #
Council position
Article 3 – paragraph 1 – point (f) – subparagraph 2 – indent 2
Article 3 – paragraph 1 – point (f) – subparagraph 2 – indent 2
– a substance classified as hazardous or meeting the criteria for classification as hazardous according to Regulation (EC) No 1272/2008, and present in the biocidal product at a concentration leading the product to be regarded as hazardous within the meaning of that Regulation; Or. en (Reinstatement of the Commission text.)
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 123 #
Proposal for a regulation
Recital 61 a (new)
Recital 61 a (new)
61a. There is scientific uncertainty about the safety of nanomaterials for human health and the environment; for example the EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR ) identified some specific health hazards as well as toxic effects on environmental organisms for some nanomaterials. SCENIHR furthermore found a general lack of high-quality exposure data for both humans and the environment, concluding that the knowledge on the methodology for both exposure estimates and hazard identification needs to be further developed, validated and standardized. More and more biocidal products contain nanosilver.
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 132 #
Proposal for a regulation
Article 2 – paragraph 8
Article 2 – paragraph 8
8. BThe data provided for biocidal products which obtained the final approval under the International Convention for the Control and Management of Ships' Ballast Water and Sediments shall be considered as authorised under Chapter VII ofwhen deciding about authorisations of such products pursuant to this Regulation. Articles 38 and 57 shall apply accordingly.
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 143 #
Council position
Article 6 – paragraph 2 – subparagraph 1 – point a
Article 6 – paragraph 2 – subparagraph 1 – point a
(a) the data are not necessary owing to theas all relevant exposure associated with the proposed uses; can be ruled out; Or. en (Reinstatement of amendment 47 of first reading.)
Amendment 148 #
Council position
Article 8 – paragraph 3
Article 8 – paragraph 3
3. Where the evaluating competent authority considers that there are concerns with regard to the cumulative effects from the use of biocidal products containing the same active substance, or different substances with similar or common effects on the same endpoints, whether by the same or different mechanism of action, it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 and include this as part of its conclusions. Or. en (Reinstatement of amendment 57 from first reading.)
Amendment 149 #
Council position
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The Commission shall, on receipt of the opinion of the Agency referred to in Article 8(4), either: (a) adopt an implementing Regulation providing that an active substance is approved, and under whichadopt, by means of delegated acts in accordance with Article 82, a decision on the inclusion of the active substance in Annex -I, including the conditions, of the includingsion, the dates of approvalinclusion and of expiry of the approval; or (b) n cases where the requirements of Article 4(1) or, where applicable, Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, adopt an implementing decision that an active substance is not approved. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 81(3)inclusion, or on the non- inclusion of the active substance in Annex I.
Amendment 150 #
Council position
Article 10 – paragraph 1 – point a a (new)
Article 10 – paragraph 1 – point a a (new)
Amendment 150 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. An active substance shall be included in Annex I for an initial period not exceeding 10 years if the biocidal products containing that active substance fulfil the conditions laid down in point (b) of Article 16(1). An active substance referred to in Article (5) may only be included in Annex I for an initial period of 5 years.
Amendment 151 #
Council position
Article 10 – paragraph 1 – point c a (new)
Article 10 – paragraph 1 – point c a (new)
Amendment 153 #
Council position
Article 10 – paragraph 1 – point d
Article 10 – paragraph 1 – point d
(d) there are reasons for concern linked to the nature of the critical effects, in particular developmental neurotoxic or immunotoxic effects, which, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures; Or. en (Reinstatement of the text of the Commission proposal.)
Amendment 157 #
Council position
Article 12 – paragraph 3
Article 12 – paragraph 3
3. Unless otherwisemore strictly specified in the decision to renew the approval of an active substance, the renewal shall be for fifteten years for all product-types to which the approval applies. Or. en (Reinstatement of amendment 71 from first reading.)
Amendment 160 #
Council position
Article 14 – paragraph 4
Article 14 – paragraph 4
4. The Commission shall, on receipt of the opinion of the Agency, adopt: (a) an implementing Regulation providing that the approval of an, by means of delegated acts in accordance with Article 82, a decision on the renewal of the inclusion of the active substance is renewedn Annex -I for one or more product-types, and under which conditions; or (b) an implementing decision that the approval of an active substance is not renewed. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 81(3). Article 9(2) shall applyor of the non-renewal of inclusion. In the event that the inclusion is renewed, the decision shall state the conditions of renewal and the dates of renewal and of expiry of inclusion.
Amendment 160 #
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 normal conditions of use, is negligible, in particular wherethat is, the product is used in closed systems or strictly controlled conditions; in other conditions excluding contact with humans and where residues of the active substance do not exceed the limit of detection;
Amendment 161 #
Council position
Article 15 – paragraph 1 – subparagraph 1
Article 15 – paragraph 1 – subparagraph 1
The Commission may review the approval of an active substance for one or more product-types at any time where there are seriousignificant indications that any of the conditions laid down in Article 4(1) or, where relevant, Article 5(2) are no longer met. The Commission may also review the approval of an active substance for one or more product-types at the request of a Member State if there are indications that the use of the active substance in biocidal products or treated articles raises seriousignificant concerns about the safety of such biocidal products or treated articles. The Commission may also review inclusion where there are significant indications that the objectives of Article 4(1)(a)(iv), Article 4(1)(b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may not be achieved. Or. en (Reinstatement of amendment 74 from first reading in a modified form.)
Amendment 161 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point b
Article 5 – paragraph 1 – subparagraph 1 – point b
b) it is shown that the active substance is necessary to control a serious danger to public health;on the basis of documented evidence included in the application of an active substance that that the active substance is necessary to control a serious danger to public health which cannot be contained by other available means including non-chemical methods.
Amendment 162 #
Council position
Article 15 – paragraph 1 – subparagraph 3
Article 15 – paragraph 1 – subparagraph 3
On duly justified imperative grounds of urgency the Commission shall adopt immediately applicable implementingdelegated acts in accordance with the procedure referred to in Article 81(4)3.
Amendment 163 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point c
Article 5 – paragraph 1 – subparagraph 1 – point c
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 173 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2 a (new)
Article 5 – paragraph 1 – subparagraph 2 a (new)
Amendment 174 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2 b (new)
Article 5 – paragraph 1 – subparagraph 2 b (new)
2b. The use of any biocidal product containing active substance 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. In any case, the application of such products shall be limited to professional users. A Member State authorising a biocidal product containing an active substance included in Annex I pursuant to this paragraph shall draw up a phasing out plan concerning the control of the serious danger by other means, including non- chemical methods, and shall without delay transmit that plan to the Commission.
Amendment 175 #
Proposal for a regulation
Article 5 – paragraph 2 – point d
Article 5 – paragraph 2 – point d
d) active substances identified under Article 57(f) of Regulation (EC) No 1907/2006 as havingwhich, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the Agency, as having endocrine disrupting properties may cause adverse effect in humans, or identified under Article 57(f) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties. Until 13 December 2013, the Commission shall, by means of delegated acts in accordance with Article 72, adopt measures on specific scientific criteria for determining endocrine-disrupting properties. Pending the adoption of these criteria, substances that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogenic category 2 and toxic for reproduction category 2, shall be considered to have endocrine- disrupting properties. In addition, substances such as those that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 2 and which have toxic effects on the endocrine organs, may be considered to have such endocrine disrupting properties.
Amendment 181 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1 – point a
Article 6 – paragraph 1 – subparagraph 1 – point a
a) a dossier for the active substance and its residues satisfying the requirements set out in Annex II;
Amendment 183 #
Proposal for a regulation
Article 6 – paragraph 2 – point a
Article 6 – paragraph 2 – point a
a) the information is not necessary owing to the exposure associatas the relevant exposure can be excluded with the proposed uses;
Amendment 184 #
Proposal for a regulation
Article 6 – paragraph 2 – point b
Article 6 – paragraph 2 – point b
Amendment 185 #
Proposal for a regulation
Article 54 – paragraph 4 a (new)
Article 54 – paragraph 4 a (new)
4a. No later than 2 years after the entry into force of this regulation, the Commission shall submit a report on the assessment of the risks to human health and the environment presented by nano- active and nano-biocidal substances and on the specific measures which should, if appropriate, be taken with regard to them.
Amendment 186 #
Proposal for a regulation
Article 6 – paragraph 2 – point c
Article 6 – paragraph 2 – point c
Amendment 187 #
Council position
Article 22 – paragraph 3 a (new)
Article 22 – paragraph 3 a (new)
Amendment 190 #
Council position
Article 22 – paragraph 7
Article 22 – paragraph 7
7. Where it is decided not to authorise or to restrict the use of a biocidal product pursuant to paragraph 3, that cancellation or amendment of the authorisation shall take effect fivthree years after that decision. However, where the approval of the active substance which is a candidate for substitution expires on an earlier date, the cancellation of the authorisation shall take effect on that earlier date. Or. en (Reinstatement of amendment 128 from first reading.)
Amendment 190 #
Proposal for a regulation
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4a. Scientific peer-reviewed open literature on the active substance and its relevant metabolites dealing with side- effects on health, the environment and non-target species and published within the last 10 years before the date of submission of the dossier shall be added by the applicant to the dossier.
Amendment 192 #
Council position
Article 24 – paragraph 1 – point b a (new)
Article 24 – paragraph 1 – point b a (new)
Amendment 192 #
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. If the evaluating competent authority considers that there are concerns with regard to the cumulative effects from the use of biocidal products containing the same active substance, or different substances with similar or common effects on the same endpoints, whether by the same or different mechanism of action, it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 and include this as part of its conclusions.
Amendment 193 #
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. Within nine months after the receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the inclusion of the active substance in Annex I having regard to the conclusions of the evaluating competent authority.
Amendment 193 #
Proposal for a regulation
Article 58 – paragraph 3 a (new)
Article 58 – paragraph 3 a (new)
3a. Biocidal products which include nanomaterials or which have been manufactured by means of the nanotechnology shall be clearly labelled as such.
Amendment 214 #
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 granted or renewed for a period not exceeding tseven years.
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 217 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Unless otherwise specified in the decision to renew the inclusion of an active substance in Annex I, the renewal shall be for an unlimited period of time period not exceeding 15 years. The renewal of approval of substances covered by Article 5 shall be for a period not exceeding five years.
Amendment 218 #
Council position
Article 36 – paragraph 1 – subparagraph 1 – point e a (new)
Article 36 – paragraph 1 – subparagraph 1 – point e a (new)
(e a) implementation of other relevant Union legislation, and in particular Directive 98/83/EC.
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 237 #
Proposal for a regulation
Article 16 – paragraph 1 – point b – subpoint iii
Article 16 – paragraph 1 – point b – subpoint iii
iii) it shas no unacceptable effects itself or as a result of its residues, directly or indirectly, on human or animal health; ll have no immediate or delayed harmful effect on human health itself or as a result of its residues, including that of vulnerable groups, or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Agency to assess such effects are available; or on groundwater;
Amendment 239 #
Council position
Article 41 – paragraph 2 a (new)
Article 41 – paragraph 2 a (new)
Amendment 242 #
Proposal for a regulation
Article 16 – paragraph 1 – point b – subpoint iv – indent 2
Article 16 – paragraph 1 – point b – subpoint iv – indent 2
- contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil taking into account locations distant from its use following long-range environmental transportation;
Amendment 245 #
Council position
Article 43 – paragraph 4 – subparagraph 2
Article 43 – paragraph 4 – subparagraph 2
Amendment 248 #
Council position
Article 47 – paragraph 1 – point a a (new)
Article 47 – paragraph 1 – point a a (new)
Amendment 252 #
Council position
Article 54 – paragraph 1 – subparagraph 1
Article 54 – paragraph 1 – subparagraph 1
By way of derogation from Articles 17 and 18, a competent authority may permit, for a period not exceeding 270 dayfour months, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use, if such a measure is necessary because of a danger to public health or the environment which cannot be contained by other means. , and if all of the following conditions are met: (a) the active substances concerned are approved for inclusion in Annex I or evaluated according to Article 4 of this Regulation and a full dossier is provided; (b) if the relevant active substances fall under Article 5(1) or 10(1), 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 two years of the date of approval; and (c) 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 . Or. en (Reinstatement of amendment 175 from first reading.)
Amendment 253 #
Council position
Article 54 – paragraph 2
Article 54 – paragraph 2
Amendment 258 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 2 – point c – introductory part
Article 17 – paragraph 1 – subparagraph 2 – point c – introductory part
c) it contains one or more active substances which are a substance of concern or which have been classified in accordance with Regulation (EC) No 1272/2008 as or which meets the criteria to be classified as one of the following:
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 262 #
Council position
Article 57 – paragraph 4
Article 57 – paragraph 4
Amendment 263 #
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) it contains a nanomaterial.
Amendment 264 #
Council position
Article 57 – paragraph 7
Article 57 – paragraph 7
7. Where there are seriousignificant indications that an active substance contained in a biocidal product with which a treated article is treated or which it incorporates does not meet the conditions laid down in Article 4(1), 5(2) or 24, the Commission shall review the approval of that active substance or its inclusion in Annex I in accordance with Article 15(1) or 27(2). (Amendment in line with part of amendment 74 of first reading in a modified form.)Or. en
Amendment 270 #
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
2. Notwithstanding paragraph 1, a biocidal product shall be considered a low-risk biocidal product if the active substances in the biocidal product are contained in such way that only a negligible exposure can take place under normal conditions of use, that is, the product is used in closed systems or in other conditions excluding contact with humans, where residues of the active substance do not exceed the limit of detection, and the product is handled under strictly controlled conditions during all other stages of its lifecycle.
Amendment 274 #
Council position
Article 64 – paragraph 3 – subparagraph 1 – point b
Article 64 – paragraph 3 – subparagraph 1 – point b
(b) information on any poisonings, especially regarding vulnerable groups, and the actions taken to lower the risk of future cases, and, where available, occupational diseases involving biocidal products. Or. en (Reinstatement of amendment 200 from first reading.)
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 310 #
Proposal for a regulation
Article 21 – paragraph 7
Article 21 – paragraph 7
7. Where it is decided not to authorise or to restrict the use of a biocidal product pursuant to paragraph 3, that cancellation or amendment of the authorisation shall take effect fivthree years after the decision or at the end of the inclusion period of the candidate for substitution, whichever is the earlier.
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 #
Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 1 - introductory part
Article 29 – paragraph 1 – subparagraph 1 - introductory part
1. The competent authority that has received an application for mutual recognition in accordance with Articles 25 or 28 may, within two months from the receipt of the application, propose to the applicant that certain conditions referred to in points (d) (e), (f), (h), (j), (k) and (l) of Article 58(2) in the authorisation be adjusted to local circumstances, so that conditions for issue of an authorisation laid down in Article 16 are satisfied, and shall inform the Commission thereof, if it establishes that, in its territory, one of the following conditions is met:
Amendment 320 #
Proposal for a regulation
Article 29 – paragraph 1 – point c
Article 29 – paragraph 1 – point c
c) the relevant circumstances of use, in particular the climate or the breeding period of the target species, differ significantly from those in the Member State where the initial evaluation was carried out or the Member State where the initial national authorisation was issued, and an unchanged national authorisation may therefore present unacceptable risks to humans or to the environment.
Amendment 321 #
Proposal for a regulation
Article 29 – paragraph 1 – point c a (new)
Article 29 – paragraph 1 – point c a (new)
ca) an unchanged national authorisation may present harmful effects on human health or unacceptable effects on the environment.
Amendment 324 #
Proposal for a regulation
Article 29 – paragraph 2 – subparagraph 2
Article 29 – paragraph 2 – subparagraph 2
Amendment 327 #
Proposal for a regulation
Article 31 – title
Article 31 – title
Derogation regarding certain active substances or product- types Or.en ((Linked to the amendment of Article 31.) )
Amendment 328 #
Proposal for a regulation
Article 31
Article 31
By way of derogation from Articles 25 and 28, competent authorities of Member States may refuse mutual recognition of national authorisations granted for active substances referred to in Article 5 and 9 and 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, 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 331 #
Proposal for a regulation
Article 32 - paragraph 1a (new)
Article 32 - paragraph 1a (new)
A Community authorisation may not be granted for biocidal products that contain active substances that fall under Article 5 or 9.
Amendment 336 #
Proposal for a regulation
Article 33 – paragraph 1 – point a
Article 33 – paragraph 1 – point a
a) biocidal products containing one or more new active substances, provided there is a need for such a product in all Member States, and that there are no non-chemical alternatives;
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 357 #
Council position
Annex VI – Conclusion – point 68 – introductory part
Annex VI – Conclusion – point 68 – introductory part
68. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 18(1) 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: Or. en (Reinstatement of amendment 328 from first reading)
Amendment 358 #
Council position
Annex VI – Conclusion – point 68 – indent 1 a (new)
Annex VI – Conclusion – point 68 – indent 1 a (new)
Amendment 369 #
Proposal for a regulation
Article 44 – paragraph 3 – introductory part
Article 44 – paragraph 3 – introductory part
3. A biocidal product shall be considered as substantially identical to the reference product if oneall of the following conditions isare met:
Amendment 372 #
Proposal for a regulation
Article 44 – paragraph 3 – point b
Article 44 – paragraph 3 – point b
b) it is either the same or similar with regard to the active and non-active substances present and the type of formulation;
Amendment 398 #
Proposal for a regulation
Article 47 – paragraph 2 – point a
Article 47 – paragraph 2 – point a
a) the words "treated with biocides", followed by the name of all active substances that were used to treat the article or materials or that were incorporated in the articles or materials; the names of all nanomaterials shall be followed by the word "nano" in brackets;
Amendment 439 #
Proposal for a regulation
Article 58 – paragraph 2 – point c a (new)
Article 58 – paragraph 2 – point c a (new)
(ca) all nanomaterials followed by the word "nano" in brackets;
Amendment 477 #
Proposal for a regulation
Annex I - introductory paragraph (new)
Annex I - introductory paragraph (new)
Substances listed in Annex I do not cover nanomaterials, except where specifically mentioned.
Amendment 478 #
Proposal for a regulation
Annex I -difenacoum - 9th row - 8th column
Annex I -difenacoum - 9th row - 8th column
In view of the fact that the active substance characteristics meet the criteria for classification as toxic to reproduction category 1A and render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, the active substance shall be considered a candidate for substitution in accordance with Article 9. Authorisations are subject to the following conditions: In view of the risks identified for the aquatic compartments, the fact that the active substance is very toxic to birds and mammals, the risks for infant poisoning, the problem of resistance formation and the pain and prolonged suffering it causes in target animals, authorisations are subject to the following condition: A serious danger to public health is proven that cannot be controlled by any other means. The following risk mitigation measures shall be taken: (1) The nominal concentration of the active substance in the products shall not exceed 75 mg/kg and only ready-for-use products shall be authorised. (2) Products shall contain an aversive agent and, where appropriate, a dye. (3) Products shall not be used as tracking powder. (4) Primary as well as secondary exposure of humans, non-target animals and the environment arshall be minimised, by considering and applying all appropriate and available risk mitigation measures. These include, amongst others, that the use shall be restrictioned to professional use only, settingthat an upper limit to the package size and laying down obligshall be set and thati ons to usely tamper resistant and secured bait boxes shall be used.
Amendment 511 #
Proposal for a regulation
Annex II -title 1 - table - section 8.1 - introductory part
Annex II -title 1 - table - section 8.1 - introductory part
8.1. Identification of any substances falling within the scope of List I or List II of the Annex to Directive 80/68/EEC on the protection of groundwater against pollution caused by certain dangerous substances. , Annex I Part B to Directive 98/83/EC on the quality of water intended for human consumption, or Annex X to Directive 2000/60/EC establishing a framework for Community action in the field of water policy.
Amendment 531 #
Proposal for a regulation
Annex III - point 5
Annex III - point 5
Tests submitted for the purpose of authorisation shall be conducted according to the methods described in Council 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 the validity of which must be justified in the application.
Amendment 567 #
Proposal for a regulation
Annex VI - introduction - point 2
Annex VI - introduction - point 2
2. In order to ensure a high and harmonised level of protection of human and animal health and of the environment, any risks arising from the use of a biocidal product shall be identified. To achieve this, a risk assessment shall be carried out to determine the acceptability or otherwise of any risks identified during the proposed normal use of the biocidal product. This is done by carrying out an assessment of the risks associated with the relevant individual components of the biocidal product, taking due account of cumulative, combination and synergistic effects.
Amendment 568 #
Proposal for a regulation
Annex VI - introduction - point 3
Annex VI - introduction - point 3
3. A risk assessment on the active substance or substances present in the biocidal product is always required. This will already have been carried out for the purpose of the inclusion of the active substance into Annex I. This risk assessment shall entail hazard identification, and, as appropriate, dose (concentration) - response (effect) assessment, exposure assessment and risk characterisation, taking due account of cumulative, combination and synergistic effects. Where a quantitative risk assessment cannot be made a qualitative assessment shall be produced.
Amendment 573 #
Proposal for a regulation
Annex VI - evaluation - point 15
Annex VI - evaluation - point 15
15. For each active substance and each substance of concern present in the biocidal product, the risk assessment shall entail a hazard identification and the establishment of appropriate no-observed- adverse-effect levels (NOAEL), where possible. It shall also include, as appropriate, a dose (concentration) - response (effect) assessment, together with an exposure assessment and a risk characterisation, taking due account of cumulative, combination and synergistic effects.
Amendment 577 #
Proposal for a regulation
Annex VI- decision making - point 59 - indent 2
Annex VI- decision making - point 59 - indent 2
- the nature and severity of the effect, taking due account of cumulative, combination and synergistic effects