65 Amendments of Gianantonio DA RE related to 2023/0124(COD)
Amendment 81 #
Proposal for a regulation
Recital 1
Recital 1
(1) The conditions for placing and making available on the market of detergents and surfactants for detergents have been harmonised through Regulation (EC) No 648/2004 of the European Parliament and of the Council29 . _________________ 29 Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1).
Amendment 95 #
Proposal for a regulation
Recital 19
Recital 19
(19) In order to safeguard the functioning of the internal market and to ensure that the objective of providing a high level of protection of health and the environment is achieved, it is necessary to establish that detergents and surfactants from third countries entering the Union market also comply with this Regulation. In particular, it is necessary to ensure that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those products. It is also necessary to lay down rules for importers to ensure that the detergents and surfactants they place on the market comply with those requirements and that the documentation drawn up by manufacturers and, where relevant, the CE marking areis available for inspection by the competent national authorities. Provision should also be made for importers to ensure that a product passport is available for those products.
Amendment 101 #
Proposal for a regulation
Recital 24
Recital 24
Amendment 103 #
Proposal for a regulation
Recital 28
Recital 28
(28) Fragrance substances are organic compounds with characteristic, usually pleasant, odours, which are widely used in detergents but also in many other products such as perfumes and other perfumed cosmetics. Those substances could cause an allergic reaction upon contact, especially to sensitised persons, even when contained in low concentrations. Therefore, it is important to provide information on the presence of individual allergenic fragrances in detergents so that sensitised persons can avoid contact with the substance to which they are allergic. It is therefore necessary to lay down strict requirements for the labelling of allergenic fragrances. However, those substances could also trigger a labelling requirement under Regulation (EC) No 1272/2008. Specific labelling requirements should therefore be established that would apply only when the labelling thresholds under Regulation (EC) No 1272/2008 are not met. This will not only prevent the unnecessary burden for economic operators but also ensure that end-users receive this information presented in a clear manner thus providing a high level of protection of human health even for sensitised persons. As the fragrance allergens established in Regulation (EC) No 1223/2009 are directly applicable to detergents under this Regulation, the same transition periods should apply to both cosmetic and detergent products.
Amendment 107 #
Proposal for a regulation
Recital 31
Recital 31
(31) Digital labelling could improve the communication of labelling information both by avoiding overcrowded physical labels and by allowing users to rely on various reading options available only for digital formats, such as increased font, automatic search, loud speakers or translation into other languages. Providing digital labels could also lead to a more efficient management of the labelling obligations by economic operators, by facilitating the update of labelling information, reducing labelling costs and permitting a more targeted information of users. Therefore, economic operators should be allowed to provide certain labelling information only through the digital label subject to certain conditions to ensure a high level of protection of detergents’ users.
Amendment 111 #
Proposal for a regulation
Recital 32
Recital 32
(32) To avoid imposing an unnecessary administrative burden for economic operators and since, in most cases, the digital label is onlyften complementary to the physical one, economic operators should be able to decide whether to use digital labels or provide all the information on a physical label only. The choice to provide a digital label should rest with manufacturers and importers, who are responsible for providing the accurate set of labelling information.
Amendment 114 #
Proposal for a regulation
Recital 33
Recital 33
(33) Digital labelling could also create challenges for the vulnerable population groups with no or insufficient digital skills and lead to an accentuation of the digital divide. For this reason, the specific information to be provided only in a digital label should reflect the current state of the digitalisation of the society and the particular situation of detergents users. In addition, all the labelling information concerning the protection of health and the environment, as well as minimum use instructions of detergents, should remain on the physical label, to enable all end- users to make informed choices before buying the detergent and to ensure its safe handling.
Amendment 116 #
Proposal for a regulation
Recital 34
Recital 34
Amendment 122 #
Proposal for a regulation
Recital 36
Recital 36
(36) Given the current development of the digital skills, economic operators should also provide the labelling information by alternative means to end- users when they cannot access the digital label. This obligation should be imposed as a safety measure to reduce any potential risks by the unavailability of the labelling information, in particular as regards refilled detergents, where all the information may be provided in a digital label.
Amendment 124 #
Proposal for a regulation
Recital 37
Recital 37
(37) Since detergents have the same use and present the same risks irrespective of the format in which they are made available on the market, economic operators making detergents available on the market in a refill format should ensure that these comply with the same requirements as the pre-packaged ones. In addition, consumers should receive the required labelling information also when opting for refilled detergents. A physical copy of the label should always be visible at the refill station. The refill sale of detergents should, therefore, be explicitly covered by this Regulation in order to ensure a high level of protection of health and the environment and a level playing field for economic operators.
Amendment 128 #
Proposal for a regulation
Recital 44
Recital 44
(44) It is crucial to make clear to both manufacturers and users that by creating the product passport for detergent or surfactant and, where relevant, by affixing the CE marking, the manufacturer declares that the detergent or surfactant is in conformity with all applicable requirements and that the manufacturer takes full responsibility thereof.
Amendment 131 #
Proposal for a regulation
Recital 45
Recital 45
(45) Where certain information is provided only digitally, it is necessary to clarify that this information needs to be provided separately and clearly distinguished from each other but through a single data carrier. This will facilitate the work of market surveillance authorities but also provide clarity to end users regarding the different pieces of information that are available to them in a digital format.
Amendment 139 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation establishes rules for the free movement of detergents and surfactants in the internal market while, at the same time, ensuring a high degree of protection of health and the environment.
Amendment 143 #
Proposal for a regulation
Article 2 – paragraph 1 – point 11 – introductory part
Article 2 – paragraph 1 – point 11 – introductory part
(11) ‘surfactant’ means any surface- active organic substance or mixture used in detergents, which has surface-active properties and which consists of one or more hydrophilic and one or more hydrophobic groups of such a nature and size that it is capable to perform allof fulfilling both of the following actionscriteria:
Amendment 144 #
Proposal for a regulation
Article 2 – paragraph 1 – point 11 – indent 1
Article 2 – paragraph 1 – point 11 – indent 1
– to reduces the surface tension of water below 45 mN/m; (at a concentration of 0.5 wt% at 20 °C)
Amendment 146 #
Proposal for a regulation
Article 2 – paragraph 1 – point 11 – indent 2
Article 2 – paragraph 1 – point 11 – indent 2
Amendment 147 #
Proposal for a regulation
Article 2 – paragraph 1 – point 11 – indent 3
Article 2 – paragraph 1 – point 11 – indent 3
– to form emulsions and/or microemulsions and/or micelless a clear micellar solution or a translucent microemulsion or stable emulsion without separation of insoluble matter when mixed with water at a concentration of 0.5 wt% and left to stand for one hour at 20°C;
Amendment 149 #
Proposal for a regulation
Article 2 – paragraph 1 – point 11 – indent 4
Article 2 – paragraph 1 – point 11 – indent 4
Amendment 152 #
Proposal for a regulation
Article 2 – paragraph 1 – point 16
Article 2 – paragraph 1 – point 16
Amendment 153 #
Proposal for a regulation
Article 2 – paragraph 1 – point 19
Article 2 – paragraph 1 – point 19
(19) ‘economic operator’ means the manufacturer, the authorised representative, the importer or the distributor;
Amendment 154 #
Proposal for a regulation
Article 2 – paragraph 1 – point 24
Article 2 – paragraph 1 – point 24
Amendment 158 #
Proposal for a regulation
Article 2 – paragraph 1 – point 34
Article 2 – paragraph 1 – point 34
Amendment 175 #
Proposal for a regulation
Article 2 – paragraph 1 – point 34 a (new)
Article 2 – paragraph 1 – point 34 a (new)
(34 a) 'model' means a combination of the product name along with the unique formula (as per the provisions for the Unique Formula Identifier (UFI), irrespective of whether a UFI code is required under Annex VIII to the CLP);
Amendment 205 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point c
Article 7 – paragraph 2 – subparagraph 2 – point c
Amendment 211 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. Manufacturers shall keep the technical documentation and the product passport for 105 years after the detergent or the surfactant covered by that documentation or product passport has been placed on the market.
Amendment 219 #
Proposal for a regulation
Article 8
Article 8
Amendment 222 #
Proposal for a regulation
Article 8 – paragraph 3 – subparagraph 2 – point b
Article 8 – paragraph 3 – subparagraph 2 – point b
(b) keep the product passport and technical documentation at the disposal of national market surveillance authorities for 105 years after the detergent or surfactant covered by those documents has been placed on the market;
Amendment 225 #
Proposal for a regulation
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
Amendment 229 #
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. Importers shall indicateWhen placing a detergent or surfactant on the market, importers shall indicate on the label of the detergent or surfactant their name, registered trade name or registered trade mark and the postal and email address ats which they can be contacted on the label of the detergent or surfactant. The contact details shall be in a language easily understood by end-users and market surveillance authoritiesell as email address or website address or phone number at which they can be contacted.
Amendment 231 #
Proposal for a regulation
Article 9 – paragraph 8
Article 9 – paragraph 8
8. Importers that consider or have reason to believe that a detergent or surfactant which they have placed on the market is not in conformity with this Regulation shall immediately takeinform the manufacturer and shall cooperate with the manufacturer and the competent authorities to ensure that the corrective measures necessary to bring that detergent or surfactant into conformity, to withdraw it or to recall it, as appropriate, are taken. Furthermore, where importers consider or have reason to believe that a detergent or surfactant which they have placed on the market presents a risk to health or to the environment, they shall immediately inform the manufacturer and the competent national authorities of the Member States in which they made the detergent or surfactant available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.
Amendment 235 #
Proposal for a regulation
Article 10 – paragraph 2 – point b
Article 10 – paragraph 2 – point b
Amendment 239 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Where a distributor considers or has reason to believe that a detergent or surfactant is not in conformity with this Regulation, the distributor shall not make the detergent or surfactant available on the market until it has been brought into conformity. Furthermore, where the detergent or surfactant presents a risk to health or the environment, the distributor shall inform the manufacturer and, where relevant, the authorised representative or the importer to that effect as well as the market surveillance authorities.
Amendment 241 #
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. Distributors that consider or have reason to believe that a detergent or a surfactant which they have made available on the market is not in conformity with this Regulation shall make immediately inform the manufacturer or importer, as applicable, and shall cooperate with the manufacturer or importer and the competent authorities to ensure that the corrective measures necessary to bring that detergent or surfactant into conformity, to withdraw it or to recall it, as appropriate, are taken. Furthermore, where distributors consider or have reason to believe that a detergent or surfactant which they have made available on the market presents a risk to health or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the detergent or surfactant available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.
Amendment 244 #
Proposal for a regulation
Article 12 – paragraph 1 – point a
Article 12 – paragraph 1 – point a
(a) to ensure that the package bears his or her name, registered trade name or registered trade mark and postal address as well as email address or website address or phone number at which they can be contacted preceded by the words ‘packaged by’ or ‘repackaged by’;
Amendment 249 #
Proposal for a regulation
Article 14
Article 14
Amendment 252 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Detergents and surfactants that are made available on the market in individual packaging or in a refill format shall be accompanied by a label. physical or digital label. The data carrier through which the digital label is accessible to the end-user shall be visible on the label or at the refill station. A physical copy of the label should always be visible at the refill station.
Amendment 253 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
Amendment 258 #
Proposal for a regulation
Article 15 – paragraph 3 – subparagraph 1 – point b
Article 15 – paragraph 3 – subparagraph 1 – point b
(b) the manufacturer’s and where relevant, the importer’s name, registered trade name or registered trade mark and the postal and email address ats which they can be contacted. The postal address shall indicate a single point at which the manufacturerell as email address or website address or phone number at which they can be contacted;.
Amendment 263 #
Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 1 – point a
Article 16 – paragraph 1 – subparagraph 1 – point a
(a) on a physical label; or
Amendment 271 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. By way of derogation from paragraph 1, where detergents are made available on the market directly to an end- user in a refill format, the label elements set out in Article 15(3) and (4) may be provided in a digital label only, with the exception of dDosage information for consumer laundry detergents as set out in point 1 and 2 of part BD of Annex V, which needs to should be provided also on a physical label.
Amendment 280 #
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
3. Where economic operators provide a digital label, the data carrier shall be accompanied by the statement ‘More comprehensive information on the product is available online’Please scan for more information’, or by a similar statement or pictogram.
Amendment 284 #
Amendment 291 #
Proposal for a regulation
Article 18 – paragraph 2 – point a
Article 18 – paragraph 2 – point a
(a) it shall correspond to a specific batchmodel of the detergent or surfactant;
Amendment 293 #
Proposal for a regulation
Article 18 – paragraph 2 – point c
Article 18 – paragraph 2 – point c
(c) it shall contain at least the information included in Annex VI, taking into account the need to protect confidential business information and trade secrets;
Amendment 297 #
Proposal for a regulation
Article 18 – paragraph 2 – point f
Article 18 – paragraph 2 – point f
(f) it shall be accessible to end-users, market surveillance authorities, customs authorities, the Commission and other economic operators, taking into account the need to protect confidential business information and trade secrets;
Amendment 301 #
Proposal for a regulation
Article 18 – paragraph 2 – point g
Article 18 – paragraph 2 – point g
(g) it shall be available for a period of 105 years after the detergent or surfactant is placed on the market, also in cases of an insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the product passport;
Amendment 311 #
Proposal for a regulation
Article 19 – paragraph 1 – point b
Article 19 – paragraph 1 – point b
(b) all information included in the product passport shall be based on open standards developed with an interoperable format and shall be machine readable, structured and searchable; , taking into account the need to protect confidential business information and trade secrets;
Amendment 315 #
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. BNo later than 60 months after entry into force of the implementing acts defining technical requirements for the digital product passport and the data carrier and the establishment of the EU registry for the unique product identifier and the unique operator identifier, economic operators shall upload, before placing a detergent or surfactant on the market, economic operators shall upload, in the registry established under Article 12(1) of Regulation (EU) …/… on Ecodesign for Sustainable Products the unique product identifier and the unique operator identifier for the detergent or surfactant.
Amendment 327 #
Proposal for a regulation
Article 25 – paragraph 1 – point a
Article 25 – paragraph 1 – point a
Amendment 331 #
Proposal for a regulation
Article 26 – paragraph 7
Article 26 – paragraph 7
7. Where individual risk-based concentration limits for fragrance allergens are established in Regulation (EC) No 1223/2009 of the European Parliament and of the Council46 , the Commission shall adopt delegated acts in accordance with Article 27 amending Annex V in order to adapt the limit of the allergenic fragrances listed in Annex III to that Regulation accordingly. The transition periods established in Regulation (EC) No 1223/2009 shall also apply to detergents under this Regulation. _________________ 46 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).
Amendment 338 #
Proposal for a regulation
Annex II – point 1 – paragraph 1 – point b – introductory part
Annex II – point 1 – paragraph 1 – point b – introductory part
(b) shall belong to both of the following:Risk Group I as defined by Directive 2000/54/EC – biological agents at work.
Amendment 341 #
Proposal for a regulation
Annex II – point 1 – paragraph 1 – point b – point i
Annex II – point 1 – paragraph 1 – point b – point i
Amendment 342 #
Proposal for a regulation
Annex II – point 1 – paragraph 1 – point b – point ii
Annex II – point 1 – paragraph 1 – point b – point ii
Amendment 348 #
Proposal for a regulation
Annex II – point 5
Annex II – point 5
5. When placed on the market, detergents containing micro-organisms shall have a standard plate count equal to or greater than 1x105 colony-forming units (CFUs) per ml in accordance with ISO 4833-1:2014, but not limited to, ISO 4833-1:2014, ISO 21149 method or equivalent.
Amendment 350 #
Proposal for a regulation
Annex II – point 6
Annex II – point 6
6. The minimum shelf life of a detergent containing micro-organisms shall not be lower than 24 months and the microbial count shall not decrease by more than 10 % every 12 months in accordance with ISO 4833-1:2014during this shelf life, the CFU count must remain equal to or greater than 1x105.
Amendment 351 #
Proposal for a regulation
Annex II – point 7
Annex II – point 7
7. Micro-organisms contained in detergents that are placed on the market in a spray format shall pass the acute inhbe evaluation toxicity test in accordance with the test method B.2., described in Part B of the Annex to Regulation (EC) No 440/2008ed using appropriate non-animal approaches to ensure consumer safety of the end product.
Amendment 353 #
Proposal for a regulation
Annex II – point 8
Annex II – point 8
Amendment 356 #
Proposal for a regulation
Annex II – point 9
Annex II – point 9
Amendment 357 #
Proposal for a regulation
Annex II – point 11
Annex II – point 11
Amendment 362 #
Proposal for a regulation
Annex V – Part A – point 4
Annex V – Part A – point 4
4. If added at concentrations exceeding 0,01 % by weight, the allergenic fragrances that are listed in entries 45, 67- 92 and [X] to [X] of Annex III to Regulation (EC) No 1223/2009, shall be labelled using the system referred to in Article 33 of that Regulation. The first sentence shall not apply to allergenic fragrances that meet the labelling thresholds under Regulation (EC) No 1272/2008. For the placing on the market and making available on the market of detergents, the same transitional periods apply as for cosmetic products as defined in Regulation (EC) No 1223/2009.
Amendment 365 #
Proposal for a regulation
Annex V – Part A – point 6 – point a
Annex V – Part A – point 6 – point a
Amendment 366 #
Proposal for a regulation
Annex V – Part B – point 1 – point a
Annex V – Part B – point 1 – point a
(a) the recommended quantities and/or dosage instructions expressed in millilitres or grams appropriate to a standard washing machine load, for soft, medium and hard water hardness levels and making provision for one or two cycle washing processes, or the recommended dosage instructions, expressed in number of units (e.g. tablets, capsules, sheets), corresponding to a standard washing machine load, adjusting the standard dosage, where relevant, for soft, medium, and hard water hardness,
Amendment 372 #
Proposal for a regulation
Annex V – Part B – point 3
Annex V – Part B – point 3
3. The label of consumer automatic dishwasher detergents shall indicate the standard dosage expressed in grams or millilitres or number of tabletsunits (e.g. tablets or capsules) for the main washing cycle for normally soiled tableware in a fully loaded 12 place settings dishwasher, adjusting the standard dosage, where relevant, for soft, medium, and hard water hardness.
Amendment 378 #
Proposal for a regulation
Annex V – Part D – paragraph 1 – point b
Annex V – Part D – paragraph 1 – point b
(b) the recommended quantities based on medium/average water hardness and different degrees of fabric soiling; and
Amendment 380 #
Proposal for a regulation
Annex V – Part D – paragraph 1 – point c
Annex V – Part D – paragraph 1 – point c
(c) an indication of the washing machinreference load.