New Formaldehyde Threshold in Cosmetic Products
The European Commission has issued a draft regulation to amend the preamble of Annex V regarding the threshold for labelling formaldehyde releasers. This amendment results from a scientific advice published by the SCCS concluding that the current threshold does not sufficiently protect consumers sensitized to formaldehyde.
Liliana Teles

Liliana Teles

Regulatory Affairs Manager

FORMALDEHYDE RELEASERS

Formaldehyde is classified as a carcinogen (category 1B) and a skin sensitizer (Category 1), according to CLP Regulation (Regulation (EC) No. 1272/2008). According to the European Cosmetics Regulation (Regulation (EC) No 1223/2009), the use of formaldehyde is prohibited in cosmetic products, and it is included in Annex II (List of Substances Prohibited in Cosmetic Products, entry 1577).

Some preservatives (allowed in cosmetics and listed in Annex V of the Cosmetics Regulation) can gradually release Formaldehyde in order to fulfil a preserving function in the final cosmetic product and are called ‘formaldehyde releasers’. According to the preamble of Annex V (List of Preservatives Allowed in Cosmetic Products) of the Regulation, “all finished products containing substances in this Annex and which release formaldehyde must be labelled with the warning ‘contains formaldehyde’ where the concentration of formaldehyde in the finished product exceeds 0.05%”.

In May 2021, the European Commission’s Scientific Committee on Consumer Safety (SCCS) published a scientific advice on the threshold for the warning ‘contains formaldehyde’ in Annex V (preamble point 2 for formaldehyde-releasing substances).

The SCCS concluded that the present threshold of 0.05% (500 ppm) does not sufficiently protect consumers sensitized to formaldehyde from exposure to free formaldehyde from formaldehyde releasers. Moreover, the SCCS concluded that this threshold should be reduced by a factor of 50, to 0.001% (10 ppm), in order to protect the vast majority of consumers. This threshold should apply to the total formaldehyde released irrespective of whether a product contains one or more formaldehyde releasers.

UPCOMING AMENDMENTS TO COSMETICS REGULATION

On October 14th, the European Commission has communicated to the WTO (World Trade Organization) a draft Regulation to amend the preamble of Annex V (List of Preservatives Allowed in Cosmetic Products). The aim is to amend the existing provision for labelling cosmetic products that contain formaldehyde releasers, taking into account the advice of the SCCS, lowering the current threshold for labelling formaldehyde releasers from 0.05% to 0.001%, in other to further protect the consumers sensitized to this substance.

Point 2 of the Preamble of Annex V is replaced by the following:

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.”

The final date for comments is December 2021 and the proposed date of adoption is set for the 2nd quarter of 2022.

The amendments to the Regulation will enter into force 20 days after its publication in the Official Journal of the European Union.

If you wish to get more information about upcoming amendments to EU cosmetic regulation, feel free to contact us at info@criticalcatalyst.com.

References:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. Regulation (EC) No. 1272/2009 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.
  3. Scientific Committee on Consumer Safety (SCCS). Scientific Advice on the threshold for the warning ‘contains formaldehyde’ in Annex V, preamble point 2 for formaldehyde-releasing substances. SCCS/1632/21. 2021.
  4. World Trade Organization (WTO). Notification G/TBT/N/EU/844. 14 October 2021.

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