Page 10 - CTPA-Annual-Report-2019-book

3 Review of the Year
CMR Substances
Substances classified as either Carcinogenic, Mutagenic or Reprotoxic (CMR) under the Classification, Labelling and Packaging Regulation (CLP) are, in general, banned from use in cosmetic products.
However, it is possible that a substance that has been safely used in cosmetic products for many years becomes classified under the CLP Regulation. In this case, for continued use
of the substance, an independent and rigorous scientific evaluation must be conducted before an exemption from the ban can be granted by the European Commission. Article 15 of the Cosmetics Regulation permits the use of CMRs under stringently controlled conditions.
CMR Category 2 substances require a positive opinion from the SCCS for continued use and Category 1A and 1B CMR substances must adhere to four strict criteria set out in Article 15 of the Cosmetics Regulation.
In the case of cosmetics, it is well known how each ingredient is used within products, how often products
will be used, by whom and where on the body.
Therefore, an assessment of the actual risk for consumers can be carried out. The CMR classification itself is purely based on hazard and gives no indication of the risk such chemicals might pose, when used in cosmetic products.
For example, a substance which can be toxic in its pure form or in high concentrations, can be safe when used in a way that does not lead to significant exposure.
During 2019, two CMR ‘Omnibus’ Regulations were published to update the Cosmetics Regulation Annexes with regards
to substances with CMR classifications under the CLP Regulation, up to and including substances that received
a CMR classification via the 13th ATP to the CLP Regulation.
Thanks to the successful defence of salicylic acid by a Cosmetics Europe consortium, the second CMR Omnibus Regulation permits the continued use of salicylic acid through both Annex III and Annex V of the Cosmetics Regulation.
The 14th and 15th ATPs to the CLP Regulation are expected to be published during 2020, which will see several more cosmetic ingredients receiving CMR classifications.
For example, titanium dioxide will be classified as a CMR 2 substance by the inhalation route through the 14th ATP
to the CLP. The anti-dandruff ingredient and preservative zinc pyrithione, the fragrance ingredient butylphenyl methylpropional (BMHCA) and the preservative sodium hydroxymethylglycinate (SHMG) are all expected to be classified as CMR 1B substances via the 15th ATP to the CLP. A robust defence is in progress for titanium dioxide to secure its continued safe use in cosmetics. A full CMR 1B exemption dossier has been submitted to the European Commission
for zinc pyrithione with the aim of supporting its continued safe use in leave-on anti-dandruff products. A decision on whether zinc pyrithione will be granted an exemption for continued use in cosmetics is expected during 2020.
2019 has seen an increase in the number of cosmetic ingredients undergoing regulatory scrutiny, for both human health and environmental concerns, and this is expected to continue throughout 2020. This has highlighted the importance of early identification of ingredients that require defence work and efficient establishment of defence consortia. CTPA chairs the ET Ingredient Monitoring and Assessment (ET IMA) team at Cosmetics Europe, which leads this important work.
Suspected Endocrine Disruptors
On 7 November 2018, the anticipated Commission Report on Article 15.4 of the Cosmetics Regulation was published. The report noted that the Cosmetics Regulation has robust processes already in place to effectively address substances with potential endocrine disrupting concerns.
Despite this, in 2019 the European Commission published a priority list of 28 substances with possible endocrine disrupting properties. The list was divided into two priority lists; Priority List A and Priority List B. Information was submitted by Cosmetics Europe in answer to a Call for Data which was issued by the European Commission for the substances on Priority List A.
In January 2020, the European Commission requested the SCCS to review the data submitted for five substances on Priority List A to confirm their safety in cosmetics. CTPA is represented on the expert groups at Cosmetics Europe with responsibility for this issue and will continue to closely monitor developments to keep members informed.
A ‘fitness check’ was initiated by the European Commission in 2019 to assess whether current legislation concerning chemicals across all sectors is sufficiently robust to
manage substances with potential endocrine disrupting properties. This includes CLP, Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and other related legislation. An outcome from the consultation is expected in mid-2020.
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