Polskie Stowarzyszenie Przemysłu Kosmetycznego i Detergentowego
PSPKiD
Polish Association of Cosmetic and Detergent Industry – we are the only Polish association in cosmetic and detergent area.
ID: 994990125637-13
Lobbying Activity
Response to Amendments following Article 15 of the cosmetic Regulation 1223/2009
24 Jul 2017
The Polish Association of Cosmetic and Detergent Industry welcomes the opportunity to comment on the CMR Omnibus proposal by the Commission and fully supports the Commission’s general proposal to list in Annex II of the Cosmetic Products Regulation CMR substances that are not authorised for use in cosmetic products.
As there appears to be no use by industry, all CMR substances that are not listed in COSING and the EU Inventory can be moved to Annex II of the Cosmetics Regulation (+/- 180 substances). Transition periods are usually necessary to allow industry to adapt to a new legal requirement and are a corner stone of good regulatory practice. In this particular case, however, there is no past or present use by our members and the substances can be listed in Annex II with immediate effect.
The following CMR substances – although listed in COSING/Inventory and in some cases in the Annexes of the Cosmetics Regulation – are not used anymore by our members as cosmetic ingredients. Transition periods are usually necessary to allow industry to adapt to a new legal requirement and are a corner stone of good regulatory practice. In this particular case, however, the substances can be listed in Annex II with immediate effect.
Chloroacetamide, Methylene chloride, Imidazole, 2-ethylhexyl-2-ethylhexanoate, N-methyl-2-pyrrolidone, 4-tert-butylbenzoic acid, N-ethyl-2-pyrrolidone, Vinyl acetate, Styrene, Acetaldehyde, Ketoconazole, Boric acid and salts that are classified as CMR, Quaternium 15.
Comments on some specific substance entries:
1. Hydroquinone is already correctly regulated under entries annex II/1339 and annex III/14. The use of hydroquinone in artificial nail systems has been assessed as safe by the SCCS and the proposed entry 1385 is therefore not necessary.
2. Paraformaldehyde and Methylene Glycol are not classified as CMR and should therefore not be banned under the Omnibus Regulation. Following the SCCS opinion related to the use of these ingredients in hair straightening products and proposes to regulate these ingredients via a separate act with a correct rationale - regulation of these two ingredients is necessary.
3. Formaldehyde - as all criteria to get an exemption under Art. 15 of Cosmetics Regulation were fulfilled i.e the SCCS confirmed the safety of the use of formaldehyde in nail hardening products, the criteria of compliance with food law is fulfilled and data demonstrating the absence of suitable alternatives have been provided by the industry – the Association disagrees with the ban of formaldehyde in nail hardening products.
4. For Furfural, TPO, PHMB an exemption procedure is ongoing and they should be regulated accordingly - where applicable with an adequate transition period. The industry should be allowed a reasonable period of time to make the necessary adjustments to product formulations in view of their placing on the market and for the withdrawal of non-compliant products from the market. For the “other conditions” for PHMB, the Association would like to propose the agreed standard wording for inhalation exposure to be consistent throughout the Regulation: ”Not to be used in applications that may lead to exposure of the end user’s lungs by inhalation” and a transitional period of 6 months for products to be made available on the market.
5. For Octamethylcyclotetrasiloxane (D4) industry previously submitted data resulting in a positive SCCS opinion in 2010. This substance was considered as undergoing a CMR exemption process. It was not included in the European Commission list of ‘Substances considered as banned under Article 15’. Consequently, some SMEs continued to use the substance in good faith in cosmetic products and an immediate ban would result in a significant impact to these businesses using an ingredient deemed safe by the SCCS. Therefore, the transition time of 12 months should be granted from the time of publication of the ban to allow companies finalisation of reformulations.
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