HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Consumer Affairs
Cosmetics and Medical devices
Brussels, 26/05/2011
SANCO/B/2/AV/bl D(2011)
10/SANCO/COS/18Standing Committee on Cosmetic Products
8 February 2011
Minutes
(1)Adoption of the agenda
The agenda was adopted.
(2)Adoption of the minutes of the Standing Committee on Cosmetic Products of 8 November 2011 (working document 10-SANCO-COS-24)
The minutes of the previous meeting were adopted.
(3)Discussion on Draft Directive on Tooth Whitening Products
COM recalled that in May 2010 a draft directive on tooth whitening products was submitted to the MS for vote by written procedure, but the Standing Committee did not deliver an opinion within the time-limit laid down.
COM explained that, in view of the concerns expressed by some MS, it was considering the option of modifying the proposal to be submitted to the Council and to be transmitted to EP by regulating the use of H2O2 in tooth whitening or bleaching products only up to the maximum concentration of 6%. This would mean that tooth whitening or bleaching products containing more than 6% hydrogen peroxide would continue to be prohibited.
It was followed by a tour de table.
(4)Draft Directive to regulate provisionally allowed hair dyes
COM submitted for a vote the draft directive to regulate 29 hair dye substances whichwere provisionally authorized for use in hair dye products until 31 December 2010 under the restrictions and conditions laid down in Part 2 of Annex III to Cosmetics Directive. The final opinions adopted by the SCCS on the safety of 27 individual substances and on their reaction products are the basis for the ban of one substance in Annex II and for the definitive regulation of 26 substances in Part 1 of Annex III to Cosmetics Directive. For the two remaining substances, the SCCS has not reached a final opinion yet. Therefore, COM proposed to adapt Annexes II and III accordingly, in particular:
–create a new entry for substance o-aminophenol in Annex II (“list of substances which must not form part of the composition of cosmetic products”);
–create new entries for 26 hair dye substances, which are currently listed in Part 2 of Annex III,in Part 1 of this Annex(“list of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down”);
–delete the corresponding entries listed in Part 2 of Annex III (“list of substances provisionally allowed”);
–extend the deadline until 31 December 2011 for provisional use of two substances in Part 2 of Annex III.
COM explained some minor changes done in the annex to the draft directive after its submission to MS on 24 January 2010. COM invited MS to submit additional linguistic comments on their national versions by the end of February. Afterwards the Committee proceeded to the vote.
The Standing Committee gave its favourable opinion by 287 votes in favour.
(5)EN ISO 22716:2007 - GMP Certificate Requests
COM informed that no more MS have contributed on this issue. One MS agreed to remove this item from the agenda and raise again the issue later on if need be.
(6)State of play:
(a)Transposition of Directives
(b)RAPEX follow-up
One MS raised the issue of formaldehyde. One MS announced that the Federal Institute for Risk Evaluation has confirmed the evaluation on formaldehyde. One delegation informed that AFSSAPS has put alerts and press communicates on its website.
(7)Any other business
(a)Information about the use of zinc oxide in sun protection products in Germany
COM informed that it received a notification from DE on the use of zinc oxide in sun protection products. DE informed that they extended the authorisation of zinc oxide as UV filter until the end of 2011. In connection with this extension, DE informed that the Federal Institute for Risk Assessment told that an upper limit of 25% should be included in the regulation and a ban on the use in sprays with a gas propellant under pressure should be included. DE expressed its hope that the COM would adopt its proposal as soon as possible, as the substance is already in use and has been used for a long time.
COM informed that the dossier on ZnO in nano form was already delivered and the SCCS already started its first reading of the dossier. The SCCS was also asked to confirm that ZnO in its non nano form its safe.
(b)Skin allergy test
At the last meeting of sub-working group on skin allergens on 8 December it was agreed that a specific workshop on skin sensitivity test should be organized in order to discuss this matter in more details, in particular in the light of the SCCP opinion of 2007. COM announced that the workshop will take place on 6 April.
ANNEX
List of participants
STANDING COMMITTEE on COSMETICS – 8/02/2011
Bundesministerium für Gesundheit / ATSPF Santé Publique / BE
Ministry of Health / BG
Ministry of Health / CY
National Institute of Public Health / CZ
BMELV
Kosmetik Kommission beim BgfR
CVUA Karlsruhe / DE
Danish Env. Protection Agency / DK
Agencia esp. de Med. y Prod. Sanitarios / ES
Health Board / EE
AFSSAPS
Ministère de la Santé
Ministère de l'Industrie
Ministère des Finances / FR
National Organisation for Medicines / EL
National Institute for Food and Nutrition / HU
Ministero Sviluppo Economico
Istituto Superiore Sanita
Ministry of Health / IT
Dpt of Health and Children
Irish Medicines Board / IE
LU
LT
Health Inspectorate / LV
Malta Standards Authority / MT
Ministry of Health, Welfare and Sport / NL
Infarmed / PT
Sanitary Inspection / PL
Ministry of Public Health / RO
Medical Products Agency / SE
Ministry of Employment and Economy / SF
Ministry of Health / SI
Public Health Office / SK
Dpt for Business, Enterprise and Regulatory Reform / UK
CH
Norwegian Food Safety Authority / NO
European Commission, Enterprise DG / EC
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