11 Amendments of Gaston FRANCO related to 2013/0150(COD)
Amendment 19 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
Amendment 20 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
Amendment 24 #
Proposal for a regulation
Recital 12
Recital 12
(12) Article 89(4) and Article 93(2) of Regulation (EU) No 528/2012 provide phase-out periods for biocidal products for which no authorisation is granted. The sameDifferent phase out periods should apply for phasing out the existing form of a product already on the market, where an authorisation is granted but the conditions of the authorisation require the product to be changedto the products depending on whether the labelling change affects the safe use and/or efficacy of the product.
Amendment 27 #
Proposal for a regulation
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Regulation 528/2012/EU
Article 3 – paragraph 1 – point s
Article 3 – paragraph 1 – point s
Article 3(1)(s) is replaced by the following: (s) "biocidal product family" means a group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their compositionand similar composition with specified variations which do not adversely affect the level of risk or significantly reduce the efficacy of the products, the active substances of which have the same specifications;
Amendment 29 #
Proposal for a regulation
Article 1 – point 1 – point b a (new)
Article 1 – point 1 – point b a (new)
(ba) Article 19(6) is replaced by the following: "6. In the case of a biocidal product family, a reduction in the percentage of one or more active substances may be allowed, and/or a variation in percentage of one or more non-active substances, and/or the replacement of one or more non-active substances by other specified substances presenting the same or lower risk. The classification, hazard and precautionary statements for each product within the biocidal product family shall be the same (with the exception of a biocidal product family comprising a concentrate for professional use and ready-for-use products obtained through dilution of that concentrate). A biocidal product family shall be authorised only if all the biocidal products within it, taking into account the permitted variations referred to in the first subparagraph,risk assessment for the biocidal product family conducted according to the common principles set out in Annex VI shall be based on the composition(s) and use(s) with the highest risk level for human health and animals, and the environment respectively. For each product within the biocidal product family, the classification, hazard and precautionary statements shall be the same as, or of a lower concern than, those of the worst-case composition(s) evaluated in the risk assessment, and the level of exposure shall be the same as or lower than the worst case use(s) evaluated in that assessment. A biocidal product family shall be authorised only if the permitted variations in composition and the uses referred to in the first subparagraph can be easily identified in the application together with their respective classification, hazard and precautionary statements and any appropriate risk mitigation measures, and if all the biocidal products within the family are expected to comply with the conditions set out in paragraph 1."
Amendment 30 #
Proposal for a regulation
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Regulation 528/2012/EU
Article 22 – paragraph 2
Article 22 – paragraph 2
(1a) in Article 22(2), point (i) is deleted;
Amendment 31 #
Proposal for a regulation
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Regulation 528/2012/EU
Article 22 – paragraph 2 – points i to p
Article 22 – paragraph 2 – points i to p
(l) application doses and instructions for use1a) in Article 22(2), point (l) is amended as follows: (l) application doses and instructions for use, in particular, relevant precautionary statements;
Amendment 35 #
Proposal for a regulation
Article 1 – point 8 a (new)
Article 1 – point 8 a (new)
Regulation 528/2012/EU
Article 69 – paragraph 1
Article 69 – paragraph 1
(8a) Article 69(1) is amended as follows: Authorisation holders shall ensure that biocidal products are classified, packaged and labelled in accordance with the approved summary of biocidal product characteristics, in particular the hazard statements and the precautionary statements, as referred to in point (i) of Article 22(2), and with Directive 1999/45/EC and, where applicable, Regulation (EC) No 1272/2008.
Amendment 46 #
Proposal for a regulation
Article 1 – point 11 – point c
Article 1 – point 11 – point c
Regulation 528/2012/EU
Article 89 – paragraph 4 – point a
Article 89 – paragraph 4 – point a
(a) the biocidal product which has not been authorised or, where relevant, which does not comply with the conditions of the authorisation, shall no longer be made available on the market with effect from 365 days after the date on which the authority gives its authorisation if the required product change concerns the information referred to in Article 69(2)(a), (c), (d), (e), (f), (g), (j), (k) or (l), or from 180 days after the date of the decision of the authority in all other cases;
Amendment 47 #
Proposal for a regulation
Article 1 – point 11 – point c
Article 1 – point 11 – point c
Regulation 528/2012/EU
Article 89 – paragraph 4 – point b
Article 89 – paragraph 4 – point b
(b) disposal and use of existing stocks of the biocidal product may continue until 550 days after the date of the decision of the authority if the required product change concerns the information referred to in Article 69(2)(a), (c), (d), (e), (f), (g), (j), (k) or (l), or until 365 days after the date of the decision of the authority in all other cases;
Amendment 48 #
Proposal for a regulation
Article 1 – point 12
Article 1 – point 12
Regulation 528/2012/EU
Article 93 – paragraph 2
Article 93 – paragraph 2
By way of derogation from Article 17(1), a Member State may continue to apply its current system or practice of making available on the market biocidal products referred to in paragraph 1 of this Article for which an application was submitted in accordance with paragraph 1 of this Article until the date of the decision granting the authorisation. In the case of a decision refusing to grant the authorisation, or imposing conditions on the authorisation making it necessary to change a product, the biocidal product which has not been authorised or, where relevant, which does not comply with the conditions of the authorisation, shall no longer be made available on the market 180 days after such a decisionand disposed of in accordance with Article 89(4).