Activities of Mario PIRILLO 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)
Shadow opinions (1)
OPINION Proposal for a regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products
Amendments (108)
Amendment 48 #
Proposal for a regulation
Recital 45
Recital 45
(45) In view of the benefits for the internal market and for the consumer, it is desirable to establish harmonised rules for parallel trade of substantially identical biocidal products that are authorised in different Member States.
Amendment 51 #
Proposal for a regulation
Recital 51
Recital 51
(51) It is essential to minimise the number of tests on animalvertebrates and to ensure that testing should beof a biocidal product and/or a biocidal active substance contained in biocidal products is made dependent on the purpose and use of a product. Applicants should share, and not duplicate, vertebrate animal studies in exchange for equitable compensation. In absence of an agreement on sharing of vertebrate animal studies between the data owner and the prospective applicant, the Agency should allow the use of the studies by the prospective applicant without prejudice to the decision on the compensation made by national courts. A Community register listing the contact details of the owners of such studies should be established and put at the disposal of all authorities to inform prospective applicants. These applications will not apply to those animal tests, such as efficacy tests, where no additional suffering is anticipated over and above that caused by normal rearing practices.
Amendment 56 #
Proposal for a regulation
Article 3 – paragraph 1 – point f – subparagraph 2 a (new)
Article 3 – paragraph 1 – point f – subparagraph 2 a (new)
Unless there are other grounds for concern, such a substance should normally be a substance classified as hazardous pursuant to Council Directive 67/548/EEC of 27 June 1967 and be present in the biocidal product in a concentration such as to require it to be regarded as hazardous within the meaning of Directive 1999/45/EC or Regulation (EC) No 1272/2008.
Amendment 57 #
Proposal for a regulation
Article 3 – paragraph 1 – point k
Article 3 – paragraph 1 – point k
(k) 'treated material or article' means any substance, mixture, material or article which was treated with or incorporates one or more biocidal products with the intention to protectduce the substance, mixture, material or article from deterioration caused by harmful organismsbiocidal effect which is their purpose;
Amendment 61 #
Proposal for a regulation
Article 3 – paragraph 1 – point p
Article 3 – paragraph 1 – point p
(p) 'frame formulation' means a group of 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, provided that, irrespective of these variations, the level of risk does not adversely affect the level of risk orexceed that attached to the reference biocidal products and the efficacy ofn thes target organism corresponds to what is indicated on the label of the products;
Amendment 62 #
Proposal for a regulation
Article 3 – paragraph 1 – point q
Article 3 – paragraph 1 – point q
(q) 'letter of access' means an original document, signed by the owner or owners of information or their representative, which states that the information may be used by the designated competent authorities, the European Chemicals Agency, or the Commission for the purpose of evaluating an active substance or granting an authorisation to a third party;
Amendment 73 #
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) the exposure of humans to that active substance in a biocidal product, under normalprescribed conditions of use, is negligible or adequately controlled, taking account of the intrinsic hazards presented by the substance, in particular where the product is used in closed systems or strictly controlled conditions;
Amendment 74 #
Proposal for a regulation
Article 5 – paragraph 1 - subparagraph 2
Article 5 – paragraph 1 - subparagraph 2
Amendment 75 #
Proposal for a regulation
Article 5 – paragraph 2 – subparagraph 1 a (new)
Article 5 – paragraph 2 – subparagraph 1 a (new)
Implementing measures shall be applied which specify the scientific criteria for determining the endocrine-disrupting properties adopted by the Regulation of the European Parliament and of the Council on placing plant protection products on the market.
Amendment 81 #
Proposal for a regulation
Article 8 – paragraph 5 – subparagraph 1 a (new)
Article 8 – paragraph 5 – subparagraph 1 a (new)
When the Commission decides to include the active substance in Annex I, the name(s) of the applicant(s) shall be indicated.
Amendment 82 #
Proposal for a regulation
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
5a. With the decision to include the active substance in Annex I, the Agency shall assign to the substance in question a specific registration number for the substance and for the applicant. The Agency shall without delay inform the applicant of the number and the date of registration. This registration number shall be used in all further correspondence regarding the active substance and for product authorisation as referred to in Chapter IV of this Regulation.
Amendment 84 #
Proposal for a regulation
Article 9 – paragraph 1 – point d
Article 9 – paragraph 1 – point d
Amendment 86 #
Proposal for a regulation
Article 12 – paragraph 5
Article 12 – paragraph 5
5. At the end of the period referred to in paragraph 3 or on receipt of the opinion of the Agency, the Commission shall adopt a decision concerning a renewal of the inclusion of the active substance in Annex I. That decision, designed to amend non- essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4). If the Commission decides to renew the inclusion of the active substance in Annex I, mention should be made of the name of the applicant(s).
Amendment 87 #
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1
Article 15 – paragraph 2 – subparagraph 1
2. Application for authorisation shall be made by, or on behalf of, the person who shall belding the authorisation, who may or may not be the person responsible for the placing on the market of a biocidal product in a particular Member State or in the Community.
Amendment 90 #
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 3 a (new)
Article 15 – paragraph 2 – subparagraph 3 a (new)
An applicant seeking authorisation for a group of products as part of a frame formulation may submit a single application for authorisation.
Amendment 110 #
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 that is a candidate for substitution in accordance with Article 9(1). The comparative assessment must be carried out for all biocidal products having the same purpose, when sufficient experience has been gained in their use and they have been in use for at least five years.
Amendment 113 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. The results of the comparative assessment shall be forwarded, without delay, to the competent authorities of other Member States and the Agency and, in the case of evaluationrenewal of an application for a Community authorisation, also to the Commission.
Amendment 114 #
Proposal for a regulation
Article 21 – paragraph 2 a (new)
Article 21 – paragraph 2 a (new)
2a. By way of derogation from paragraph 1, a comparative assessment shall not be required for biocidal products whose use has been shown to be safe.
Amendment 116 #
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
3. The receiving competent authority or, in the case of a decision on an application for renewal of a Community authorisation, the Commission shall prohibit or restrict the placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with Annex VI demonstrates that all the following criteria are met: a) for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention method already exists which presents significantly lower risk for human or animal health or the environment; b) the biocidal product or non-chemical control or prevention method and which proves equally effective and involves no significant increase in the risks for any other parameter; b) the biocidal product referred to in point (a) does not present significant economic or practical disadvantages; c) the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target harmful organism.
Amendment 118 #
Proposal for a regulation
Article 21 – paragraph 4
Article 21 – paragraph 4
4. By way of derogThe Commission shall adopt implementing measures which specify the procedure required to define the application fror com 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 that product in practicetive assessment for biocidal products in accordance with the provisions of paragraph 3. These measures shall define the criteria and algorithms to be used for the comparative assessments so as to ensure uniform application throughout the Community. These measures shall be adopted in accordance with the procedures laid down in Article 72(3).
Amendment 119 #
Proposal for a regulation
Recital 45
Recital 45
(45) In view of the benefits for the internal market and for the consumer, it is desirable to establish harmonised rules for parallel trade of substantially identical biocidal products thatwhich are authorised in different Member States.
Amendment 121 #
Proposal for a regulation
Articolo 23 – paragraph 1
Articolo 23 – paragraph 1
1. The receiving competent authority shall, within twelvesix months after the validation referred to in Article 22, decide on the application in accordance with Article 16.
Amendment 125 #
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 1
Article 24 – paragraph 1 – subparagraph 1
1. The authorisation holder or his representative shall submit an application for renewal of a national authorisation to the receiving competent authority at least eighteentwelve months before the expiry date of the authorisation.
Amendment 126 #
Proposal for a regulation
Article 25 – paragraph 5 – subparagraph 1 a (new)
Article 25 – paragraph 5 – subparagraph 1 a (new)
In the event of mutual recognition, a single authorisation number shall be used in all Member States involved.
Amendment 127 #
Proposal for a regulation
Article 25 – paragraph 5 a (new)
Article 25 – paragraph 5 a (new)
5a. In the case of mutual recognition procedures, the Commission shall adopt implementing measures laying down the criteria and procedures for assigning a single authorisation number in all Member States concerned.
Amendment 128 #
Proposal for a regulation
Article 27 – paragraph 1 – subparagraph 2
Article 27 – paragraph 1 – subparagraph 2
Amendment 130 #
Proposal for a regulation
Article 27 – paragraph 1 – subparagraph 2 a (new)
Article 27 – paragraph 1 – subparagraph 2 a (new)
Within three months of receiving the notification, the Commission shall make a proposal for a decision. Should the Commission ask the Agency for an opinion under the procedure set out in Article 30, the three-month period shall be suspended until the Agency has forwarded its opinion.
Amendment 134 #
Proposal for a regulation
Article 29 – paragraph 2 – subparagraph 2
Article 29 – paragraph 2 – subparagraph 2
The Commission shall, after consultation with the applicant, adopt a decision on the proposed adjustment of the conditions of the national authorisation to local circumstances in accordance with the procedure referred to in Article 72(3). The competent authority of the concerned Member State shall without delay adopt all appropriate measures to comply with that decision.
Amendment 136 #
Proposal for a regulation
Article 29 – paragraph 2 – subparagraph 2 a (new)
Article 29 – paragraph 2 – subparagraph 2 a (new)
Amendment 140 #
Proposal for a regulation
Article 33 – paragraph 1 – introductory part
Article 33 – paragraph 1 – introductory part
1. The Community authorisation may be granted to the followingall categories of biocidal products:
Amendment 141 #
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
Amendment 145 #
Proposal for a regulation
Article 35 – paragraph 3 – subparagraph 1
Article 35 – paragraph 3 – subparagraph 1
3. Within ninthree months from the receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the authorisation of the biocidal product.
Amendment 146 #
Proposal for a regulation
Article 35 – paragraph 5
Article 35 – paragraph 5
Amendment 148 #
Proposal for a regulation
Article 36 – paragraph 1 – subparagraph 1
Article 36 – paragraph 1 – subparagraph 1
1. The authorisation holder or his representative shall submit an application for renewal of a Community authorisation to the Agency at least 182 months before the expiry date of the authorisation.
Amendment 151 #
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 at least one of the biocidal products containing that active substance fulfils the conditions laid down in point (b) of Article 16(1).
Amendment 157 #
Proposal for a regulation
Article 44 – paragraph 1 – subparagraph 3
Article 44 – paragraph 1 – subparagraph 3
The application shall be accompanied by all the information necessary to demonstrate that the biocidal product is substantially identical to the reference product as defined in paragraph 3.
Amendment 158 #
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
3. A biocidal product shall be considered as substantially identical to the reference product if one ofall the following conditions isare met: a) the source of the active substances it contains is the same in terms of manufacturer and location of thit has been manufactured by the same company or one of its associate companies or under licence, following the same production plant; rocess; b) it is either the same or similar with regard to the non-specifications, the active substances present and the type of formulation; c) it is either the same or equivalent, as regards the co-formulants it contains and the format, materials and form of its packaging, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
Amendment 159 #
Proposal for a regulation
Article 44 – paragraph 4 – point a a new
Article 44 – paragraph 4 – point a a new
aa) the number of registrations of the active substances contained in the product and a letter of access in accordance with Article 50 from the relevant applicant under Chapter II of this Regulation;
Amendment 160 #
Proposal for a regulation
Article 44 – paragraph 4 – point c
Article 44 – paragraph 4 – point c
c) name and address of the authorisation holder in the Member State of origin and a letter of access in accordance with Article 50 from the holder of the authorisation
Amendment 162 #
Proposal for a regulation
Article 47 – paragraph 2 – point a
Article 47 – paragraph 2 – point a
a) the name of all active substances that were used to treat the article or materials or that were incorporated in the articles or materials, if significant, and of the active principles intended for release by the article or material treated, under normal and foreseeable conditions of use;
Amendment 169 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
Amendment 169 #
Proposal for a regulation
Article 47 – paragraph 2 – point c
Article 47 – paragraph 2 – point c
Amendment 170 #
Proposal for a regulation
Article 47 – paragraph 2 – point d
Article 47 – paragraph 2 – point d
(d) any hazard statement or precautionary statement set out in the authorisation for the biocidal product where relevant, and for all active substances intended to be released by the article or material treated in normal or foreseeable conditions of use.
Amendment 171 #
Proposal for a regulation
Article 47 – paragraph 2 – subparagraphs 2 and 3
Article 47 – paragraph 2 – subparagraphs 2 and 3
The labelling shall be clearly visible, easily legible and, appropriately durable. Where this is necessary because of the size or the function of the treated article or material, the labelling shall be printed and printed on the article or material, on the packaging, on the instructions for use or on the warranty of the treated article or material.
Amendment 175 #
Proposal for a regulation
Article 47 – paragraph 2 a (new)
Article 47 – paragraph 2 a (new)
2a. The person responsible for placing treated articles or materials on the market shall have a letter of certification issued by the holder of the authorisation in respect of all biocidal products that have been used for the treatment or that have been inserted into the articles or materials.
Amendment 179 #
Proposal for a regulation
Article 49 – paragraph 1 – subparagraph 2
Article 49 – paragraph 1 – subparagraph 2
Amendment 181 #
Proposal for a regulation
Article 50 – paragraph 2
Article 50 – paragraph 2
2. Revocation of a letter of access prior to its expiry date shall not affect the validity ofinvalidate the authorisation issued on the basis of the letter of access in question, unless another letter of access for an equivalent active substance is provided by the holder of the authorisation within four months .
Amendment 182 #
Proposal for a regulation
Article 51 – paragraph 2 – subparagraph 2
Article 51 – paragraph 2 – subparagraph 2
Where those tests or studies have already been submitted in connection with a previous application, the competent authority or the Agency shall without delay assess whether they are technically equivalent in the light of the reference source. If the assessment confirms the fact, the competent authority of the Agency shall communicate the name and contact details of the owner of the information to the prospective applicant.
Amendment 183 #
Proposal for a regulation
Article 52 – paragraph 3
Article 52 – paragraph 3
3. Where no such agreement is reached two months after the request was made according to Article 51(2), either the owner of the information or the prospective applicant shall without delay inform the Agency and the owner of the information thereof. Within two months of being informed about the failure to reach an agreement, the Agency shall give the prospective applicant the right to refer to the tests or studies involving tests on vertebrate animals. National courtsAn arbitration body shall decide on the proportionate share of the costall the costs relating to the compilation and use of the information that the prospective applicant shall pay to the data owner.
Amendment 184 #
Proposal for a regulation
Article 53 – paragraph 1 – subparagraph 1
Article 53 – paragraph 1 – subparagraph 1
1. In the case of a biocidal product which has already been authorised in accordance with Articles 15, 25 or 28, and where all periods of protection of information according to Article 49 have expired, the receiving competent authority or the Agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant and, if the information protection periods under Article 49 have not ended, the competent authority or the Agency may agree that a subsequent applicant for authorisation may share the data provided by the first applicant in accordance with Article 52, in so far as the subsequent applicant can provide evidence that the biocidal product is similar to and its active substances are technically equivalent to the one formerly authorised, including degree of purity and nature of impurities.
Amendment 187 #
Proposal for a regulation
Article 55 – paragraph 2 – subparagraph 1
Article 55 – paragraph 2 – subparagraph 1
2. Disclosure of the following information shall be deemed to undermine the protection of the commercial interests of the concerned person and may not be disclosed publicly: a) details of the full composition of a biocidal product; b) the precise use, function or application of a substance or mixture; c) the precise tonnage of the substance or mixture manufactured or placed on the market; d) links between a manufacturer of an active substance and the person responsible for the placing of a biocidal product on the market or between the person responsible for the placing of a biocidal product on the market and the distributors of the product; (da) manufacturers of the active substances (names and addresses including location of manufacturing sites); (db) the location of a biocidal product's manufacturing site; (dc) the date of issue of an authorisation and the expiry date; (dd) doses and instructions for use.
Amendment 191 #
Proposal for a regulation
Article 58 – paragraph 2 – point e
Article 58 – paragraph 2 – point e
e) directions for use and the dose rate, expressed in metric unita manner that is meaningful and comprehensible to users, for each use provided for under the terms of the authorisation;
Amendment 201 #
Proposal for a regulation
Article 77 – paragraph 1 – subparagraph 3
Article 77 – paragraph 1 – subparagraph 3
During the work programme, the Commission shall decide pursuant to the procedure laid down in Article 72(4) that an active substance shall be included in Annex I of this Regulation and under which conditions, or, in cases where the requirements of Article 4 are not satisfied or where the requisite information and data have not been submitted within the prescribed period, that such active substance shall not be included in Annex I of this Regulation. The decision shall specify the date on which the inclusion in Annex I becomes effective, which shall be two years after the decision.
Amendment 203 #
Proposal for a regulation
Article 9 – paragraph 1 – point d
Article 9 – paragraph 1 – point d
d) it contains a significant proportion of non-active isomers;eleted
Amendment 204 #
Council position
Article 32 – paragraph 2 – subparagraph 2
Article 32 – paragraph 2 – subparagraph 2
Within 90 days of validating the application, and subject to Articles 34, 35 and 36, the Member States concerned shall agree on the summary of biocidal product characteristics and shall record their agreement in the Register for Biocidal Products. together with the terms and conditions of the authorisation; shall authorise the biocidal product accordingly and shall record their agreement in the Register for Biocidal Products. A single authorisation number shall be used in all Member States concerned.
Amendment 211 #
Council position
Article 33 – paragraph 6
Article 33 – paragraph 6
6. The procedure shall be closed after all the Member States concerned have agreed the summary of biocidal product characteristics together with the terms and conditions of the authorisation, and recorded their agreement in the Register for Biocidal Products. A single authorisation number shall be used in all the Member States concerned.
Amendment 228 #
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1
Article 15 – paragraph 2 – subparagraph 1
2. Application for authorisation shall be made by, or on behalf of, the person who shall belding the authorisation. The person may be, but is not necessarily, the person responsible for the placing on the market of a biocidal product in a particular Member State or in the Community.
Amendment 230 #
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1
Article 15 – paragraph 2 – subparagraph 1
2. Application for authorisation shall be made by, or on behalf of, the person who shall bewill be the holder of the authorisation. This person may be, but is not necessarily, the person responsible for the placing on the market of a biocidal product in a particular Member State or in the Community.
Amendment 231 #
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 3 a (new)
Article 15 – paragraph 2 – subparagraph 3 a (new)
A single application for authorisation may be made by the applicant for a group of products intended to be authorised under a frame formulation.
Amendment 280 #
Council position
Article 65 – paragraph 2 – subparagraph 2 – point ba (new)
Article 65 – paragraph 2 – subparagraph 2 – point ba (new)
(ba) the precise use, function or application of a substance or mixture;
Amendment 283 #
Council position
Article 65 – paragraph 2 – subparagraph 2 – point da (new)
Article 65 – paragraph 2 – subparagraph 2 – point da (new)
(da) names and addresses of manufacturers of the active substances, including location of manufacturing sites;
Amendment 284 #
Council position
Article 65 – paragraph 2 – subparagraph 2 – point db (new)
Article 65 – paragraph 2 – subparagraph 2 – point db (new)
db) the location of a biocidal product's manufacturing site.
Amendment 285 #
Council position
Article 65 – paragraph 2 – subparagraph 3
Article 65 – paragraph 2 – subparagraph 3
However, where urgent action is essential to protect human health, safety or the environment or for other reasons of overriding public interest, the Agency or the competent authorities shall disclose the information referred to in this paragraph with the exception of point (d).
Amendment 286 #
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 applic, within the meaning of this Regulation for, of an authorispplication for a renewal of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 9(1). The comparative assessment must be carried out for all biocidal products having the same purpose, when sufficient experience has been gained in their use and they have been in use for at least five years.
Amendment 289 #
Council position
Article 65 – paragraph 4 – subparagraph 1a (new)
Article 65 – paragraph 4 – subparagraph 1a (new)
Information accepted as confidential by a competent authority or the Agency shall be treated as confidential by other competent authorities, the Agency and the Commission.
Amendment 291 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. The results of the comparative assessment shall be forwarded, without delay, to the competent authorities of other Member States and the Agency and, in the case of evaluationrenewal of an application for a Community authorisation, also to the Commission.
Amendment 292 #
Council position
Article 66 – paragraph 1 – subparagraph 1 – point d
Article 66 – paragraph 1 – subparagraph 1 – point d
(d) physicochemical dataendpoints and data on pathways and environmental fate and behaviour;
Amendment 292 #
Proposal for a regulation
Article 21, paragraph 2 a (new)
Article 21, paragraph 2 a (new)
2a. By way of derogation from paragraph 1, a comparative assessment shall not be required for biocidal products whose use has been shown to be safe.
Amendment 293 #
Council position
Article 66 – paragraph 1 – subparagraph 1 – point e
Article 66 – paragraph 1 – subparagraph 1 – point e
(e) the resultendpoints of each toxicological and ecotoxicological study;
Amendment 294 #
Proposal for a regulation
Article 21 – paragraph 3 – introductory part
Article 21 – paragraph 3 – introductory part
3. The receiving competent authority or, in the case of a decision on an application for renewal of a Community authorisation, the Commission shall prohibit or restrict the placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with Annex VI demonstrates that all the following criteria are met:
Amendment 298 #
Proposal for a regulation
Article 21 – paragraph 3 – point a
Article 21 – paragraph 3 – point a
a) for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention method already exists which presents significantly lower risk for human or animal health or the environment and which proves equally effective and involves no significant increase in the risks for any other parameter;
Amendment 301 #
Proposal for a regulation
Article 21 – paragraph 3 – point b
Article 21 – paragraph 3 – point b
b) the biocidal product or non-chemical control or prevention method referred to in point (a) does not present significant economic or practical disadvantages;
Amendment 305 #
Proposal for a regulation
Article 21 – paragraph 4
Article 21 – paragraph 4
4. By way of derogThe Commission shall adopt implementing measures which specify the procedure required to define the application fror com 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 that product in practicetive assessment for biocidal products in accordance with the provisions of paragraph 3. These measures shall define the criteria and algorithms to be used for a comparative assessment so as to ensure uniform application throughout the Community. These measures shall be adopted in accordance with the procedures laid down in Article 72(3).
Amendment 312 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
1. The receiving competent authority shall, within twelvesix months after the validation referred to in Article 22, decide on the application in accordance with Article 16.
Amendment 313 #
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 1
Article 24 – paragraph 1 – subparagraph 1
1. The authorisation holder or hits representative shall submit an application for renewal of a national authorisation to the receiving competent authority at least 182 months before the expiry date of the authorisation.
Amendment 314 #
Proposal for a regulation
Article 25 – paragraph 5
Article 25 – paragraph 5
5. The receiving competent authority shall authorise the biocidal product concerned under the same conditions as the reference competent authority. In the event of mutual recognition, a single authorisation number shall be used in all Member States involved. In the case of mutual recognition procedures, the Commission shall adopt implementing measures laying down the criteria and procedures for assigning a single authorisation number in all Member States concerned.
Amendment 316 #
Proposal for a regulation
Article 27 – paragraph 1 – subparagraph 2
Article 27 – paragraph 1 – subparagraph 2
The Commission shall, after consultation with the applicant, adopt a decision on whether the grounds set out by the competent authority justify refusal to recognise, or restriction of, the national authorisation in accordance with the procedure referred to in Article 72(3). Within three months of receiving the notification, the Commission shall make a proposal for a decision. Should the Commission ask the Agency for an opinion under the procedure set out in Article 30, the three-month period shall be suspended until the Agency has forwarded its opinion.
Amendment 317 #
Proposal for a regulation
Article 28 – paragraph 8 - subparagraphs 1 a and 1 b (new)
Article 28 – paragraph 8 - subparagraphs 1 a and 1 b (new)
A single authorisation number shall be used in all the Member States involved. In the case of mutual recognition procedures, the Commission shall adopt implementing measures laying down the criteria and procedures for assigning a single authorisation number in all Member States concerned.
Amendment 318 #
Proposal for a regulation
Article 28 – paragraph 9 – subparagraph 3 a (new)
Article 28 – paragraph 9 – subparagraph 3 a (new)
Within three months of receiving the notification, the Commission shall make a proposal for a decision. Should the Commission ask the Agency for an opinion under the procedure set out in Article 30, the three-month period shall be suspended until the Agency has forwarded its opinion.
Amendment 325 #
Proposal for a regulation
Article 29 – paragraph 2 – subparagraph 2
Article 29 – paragraph 2 – subparagraph 2
The Commission shall, after consultation with the applicant, adopt a decision on the proposed adjustment of the conditions of the national authorisation to local circumstances in accordance with the procedure referred to in Article 72(3). The competent authority of the concerned Member State shall without delay adopt all appropriate measures to comply with that decision.
Amendment 326 #
Proposal for a regulation
Article 29 – paragraph 2 a (new)
Article 29 – paragraph 2 a (new)
(2a) Within three months of receiving the notification, the Commission shall make a proposal for a decision. Should the Commission ask the Agency for an opinion under the procedure set out in Article 30, the three-month period shall be suspended until the Agency has forwarded its opinion.
Amendment 346 #
Proposal for a regulation
Article 35 – paragraph 3 – subparagraph 1
Article 35 – paragraph 3 – subparagraph 1
3. Within ninthree months from the receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the authorisation of the biocidal product. Or.. it
Amendment 351 #
Proposal for a regulation
Article 35 – paragraph 5
Article 35 – paragraph 5
Amendment 353 #
Proposal for a regulation
Article 36 – paragraph 1 – subparagraph 1
Article 36 – paragraph 1 – subparagraph 1
1. The authorisation holder or his representative shall submit an application for renewal of a Community authorisation to the Agency at least 182 months before the expiry date of the authorisation.
Amendment 354 #
Proposal for a regulation
Article 36 – paragraph 1 – subparagraph 1
Article 36 – paragraph 1 – subparagraph 1
1. The authorisation holder or his representative shall submit an application for renewal of a Community authorisation to the Agency at least 182 months before the expiry date of the authorisation. Or.. it
Amendment 365 #
Proposal for a regulation
Article 44 – paragraph 1 – subparagraph 1
Article 44 – paragraph 1 – subparagraph 1
1. A competent authority of a Member State (hereinafter referred to as 'Member State of introduction') may grant a parallel trade permit for a biocidal product that is authorised in another Member State (hereinafter referred to as 'Member State of origin') to be placed on the market and used in the Member State of introduction, if it determines that the biocidal product is substantially identical in composition to a biocidal product already authorised in that Member State (hereinafter referred to as 'the reference product').
Amendment 366 #
Proposal for a regulation
Article 44 – paragraph 1 – subparagraph 3
Article 44 – paragraph 1 – subparagraph 3
The application shall be accompanied by all the information necessary to demonstrate that the biocidal product is substantially identical to the reference product as defined in paragraph 3.
Amendment 367 #
Proposal for a regulation
Article 44 – paragraph 2
Article 44 – paragraph 2
2. A parallel trade permit shall be granted within two months from submission of an application. The competent authority of the Member State of introduction may request from the competent authority of the Member State of origin additional information necessary to determine whether the product is substantially identical to the reference product. The competent authority of the Member State of origin shall provide the requested information within one month of receiving the request.
Amendment 368 #
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 370 #
Proposal for a regulation
Article 44 – paragraph 3 – point a
Article 44 – paragraph 3 – point a
a) the source of the active substances it contains is the same in terms of manufacturer and location of the production plantit has been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process;
Amendment 371 #
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 toidentical with regard to the specification and content of the non-active substances present and in the type of formulation;
Amendment 374 #
Proposal for a regulation
Article 44 – paragraph 3 – point c
Article 44 – paragraph 3 – point c
c) it is either the same or equivalent with regard to the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
Amendment 375 #
Proposal for a regulation
Article 44 – paragraph 4 – point c
Article 44 – paragraph 4 – point c
(c) name and address of the authorisation holder in the Member State of origin and a letter of access in accordance with Article 50 from the authorisation holder;
Amendment 379 #
Proposal for a regulation
Article 46 – paragraph 1 – subparagraph 2
Article 46 – paragraph 1 – subparagraph 2
In the case of scientific research and development, including product and process-oriented research and development, the person who intends to carry out the experiment or the test shall notify the competent authority prior to the start. The person shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data, and quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment. The persons concerned shall, if requested, make this information available to the competent authority.
Amendment 383 #
Proposal for a regulation
Article 46 – paragraph 1 – subparagraph 3
Article 46 – paragraph 1 – subparagraph 3
Amendment 387 #
Proposal for a regulation
Article 46 – paragraph 2
Article 46 – paragraph 2
(2) An unauthorised biocidal product or an active substance for exclusive use in a biocidal product shall not be placed on the market for the purpose of any experiment or test which may involve, or result in, release of the biocidal product into the environment unless the competent authority has assessed the data submitted by the person interested in the placing of such product on the market and issued a national authorisatpositive opinion for this purpose and which limits the quantities to be used and the areas to be treated and which may impose further conditions. The competent authority shall without delay inform the Commission and other competent authorities about the issued national authorisationmay impose further conditions. In the absence of an opinion from the competent authority within 30 days of the notification of the information required in paragraph 1, the biocidal product or active substance may be placed on the market for the purpose of the notified experiment or test.
Amendment 405 #
Proposal for a regulation
Article 47 – paragraph 2 – point c
Article 47 – paragraph 2 – point c
Amendment 409 #
Proposal for a regulation
Article 47 – paragraph 2 – point d
Article 47 – paragraph 2 – point d
(d) any hazard statement or precautionary statement set out in the authorisation for the biocidal product. where relevant, and for all active substances intended to be released by the article or material treated in normal or foreseeable conditions of use.
Amendment 411 #
Proposal for a regulation
Article 47 – paragraph 2 – subparagraph 2
Article 47 – paragraph 2 – subparagraph 2
The labelling shall be clearly visible, easily legible and, appropriately durable, and printed on the article or material.
Amendment 414 #
Proposal for a regulation
Article 47 – paragraph 2- subparagrah 3 a (new)
Article 47 – paragraph 2- subparagrah 3 a (new)
The person responsible for placing treated articles or materials on the market shall have a letter of certification issued by the authorisation holder in respect of all biocidal products which have been used for the treatment or which have been inserted into the articles or materials.
Amendment 416 #
Proposal for a regulation
Article 50 – paragraph 2
Article 50 – paragraph 2
2. Revocation of a letter of access prior to its expiry date shall not affect the validity ofinvalidate the authorisation issued on the basis of the letter of access in question. Letters of access are generally provided free of charge and are linked to supply agreements. The option of revoking, unless another letters of access should agreements be violated, e.g. with alternative supplies, is intended to protect a data owner’s investments. To protect users, the product authorisation may remain valid for a permitted period in order to allow time to obtain a new letter of accessfor an equivalent active substance is provided by the authorisation holder within four months. Or. it Justification.
Amendment 426 #
Proposal for a regulation
Article 55 – paragraph 2 – introductory part
Article 55 – paragraph 2 – introductory part
2. Disclosure of the following information shall be deemed to undermine the protection of the commercial interests of the person concerned personand may not be disclosed publicly:
Amendment 428 #
Proposal for a regulation
Article 55 – paragraph 2 – points d a - d d (new)
Article 55 – paragraph 2 – points d a - d d (new)
Amendment 436 #
Proposal for a regulation
Article 58 – paragraph 2 – introductory part
Article 58 – paragraph 2 – introductory part
2. Labels shall not be misleading and, in any case, shall not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or similar indications. In addition, the label must show clearly and indelibly the following information: A low-risk biocidal product can be identified as such on the labelOr.it Justification.
Amendment 440 #
Proposal for a regulation
Article 58 – paragraph 2 – point e
Article 58 – paragraph 2 – point e
(e) directions for use and the dose rate, expressed in metric unita manner that is meaningful and comprehensible to users, for each use provided for under the terms of the authorisation;
Amendment 445 #
Proposal for a regulation
Article 62 – paragraph 3
Article 62 – paragraph 3
3. Advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health or the environment. In any case, the advertising of a biocidal product shall not mention ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or any similar indication.
Amendment 453 #
Proposal for a regulation
Article 70 – paragraph 2 – point d
Article 70 – paragraph 2 – point d
(d) an annualthe fee shall be paid by persons placing biocidal products on the marketyable only when it is genuinely necessary;
Amendment 470 #
Proposal for a regulation
Article 77 – paragraph 1 – subparagraph 3
Article 77 – paragraph 1 – subparagraph 3
During the work programme, the Commission shall decide pursuant to the procedure laid down in Article 72(4) that an active substance shall be included in Annex I of this Regulation and under which conditions, or, in cases where the requirements of Article 4 are not satisfied or where the requisite information and data have not been submitted within the prescribed period, that such active substance shall not be included in Annex I of this Regulation. The decision shall specify the date on which the inclusion in Annex I becomes effective, which is two years after the decision.