COMMISSION REGULATION (EU) 2022/1181
of 8 July 2022
amending the preamble of Annex V to Regulation (EC) No 1223/2009 of the European Parliament
and of the Council on cosmetic products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on
cosmetic products (1), and in particular Article 31(1) thereof,
Whereas:
- The substance formaldehyde (CAS No 50-00-0, EC No 200-001-8) has been classified as a carcinogen (Category 1B)
and a skin sensitizer (Category 1) in Part 3 of Annex VI to Regulation (EC) No 1272/2008 (2). According to
Article 15 of Regulation (EC) No 1223/2009, substances classified as carcinogenic of category 1B in that Annex are
to be prohibited from use in cosmetic products. Therefore, the use of formaldehyde as such has been prohibited in
cosmetic products and is currently listed in entry 1577 of Annex II to Regulation (EC) No 1223/2009. - Annex V to Regulation (EC) No 1223/2009 contains a list of substances allowed for use in cosmetic products aspreservatives. Certain of those preservatives are gradually releasing formaldehyde in order to fulfil a preserving
function in the final cosmetic product (so called formaldehyde releasers). Formaldehyde releasers are used in both
leave-on and rinse-off cosmetic products. - In order to inform consumers sensitised to formaldehyde about the presence of formaldehyde that may trigger an
allergic reaction, it is set out in point 2 of the preamble of Annex V to Regulation (EC) No 1223/2009 that all
finished products containing substances which are listed in that Annex and which release formaldehyde are to be
labelled with the specific warning ‘contains formaldehyde’ where the concentration of formaldehyde in the finished
product exceeds 0,05 %. - The Scientific Committee on Consumer Safety (SCCS) concluded, in its scientific advice of 7 May 2021 (3), that the
present threshold of 0,05 % (500 ppm) does not sufficiently protect consumers sensitised to formaldehyde. The
SCCS further concluded that in order to protect the vast majority of those consumers, the current threshold for the
labelling requirement should be reduced to 0,001 % (10 ppm), which should apply to the total formaldehyde
released irrespective of whether a product contains one or more formaldehyde releaser(s). - In light of the SCCS opinion, it can be concluded that the potential risk to human health arising from the use of
certain substances that release formaldehyde in finished cosmetic products justify a lower threshold regarding the
requirement to label such products with the specific warning ‘contains formaldehyde’ than the one currently
applicable. That threshold should be decreased as proposed by the SCCS. Regulation (EC) No 1223/2009 should
therefore be amended accordingly. - The industry should be allowed a reasonable period of time to adapt to the new requirements by making the
necessary adjustments to labelling, as well as to product formulations that are necessary to ensure that only
cosmetic products complying with the new requirements are placed on the market. Economic operators should also
be allowed a reasonable period of time to withdraw cosmetic products which do not comply with the new
requirements from the market and which were placed on the market before the new labelling provision becomes
applicable. Therefore, considering the relatively low risk associated to formaldehyde releasers and the large number
of cosmetic products concerned the transition period should be 24 and 48 months, respectively. - The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Cosmetic Products,
HAS ADOPTED THIS REGULATION:
Article 1
Point 2 to the Preamble of Annex V to Regulation (EC) No 1223/2009 is replaced by the following:
‘2. All finished products containing substances which are listed in this Annex and which release formaldehyde shall be
labelled with the warning “releases formaldehyde” where the total concentration of formaldehyde released in the
finished product exceeds 0,001 % (10 ppm), irrespective of whether the finished product contains one or more
substances releasing formaldehyde.
However, all finished products containing substances referred to in the first subparagraph which comply with
Regulation (EC) No 1223/2009 as applicable on 30 July 2022 may be placed on the Union market until 31 July 2024
and be made available on the Union market until 31 July 2026.’
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 July 2022.
For the Commission
The President
Ursula VON DER LEYEN
