28 REGULATIONS
concentration of 0.5%. The Scientific Committee on Consumer Safety concluded that climbazole was safe to use as a preservative at a maximum concentration of 0.2% in face cream, hair lotion, foot care; at 0.5% as a preservative in rinse–off shampoo; and at 2.0% as an anti- dandruff agent in rinse-off shampoo. Climbazole is currently permitted to be used as a preservative up to a maximum concentration of 0.5% (annex V, entry 32).
SCCS/1601/18 – Salicylic Acid Salicylic acid is currently permitted to be used as a preservative (annex V, entry 3) at a maximum concentration of 0.5%. It can also be used in rinse–off hair products at a maximum concentration of 3% and at up to 2% in other products when the purpose is other than to inhibit the development of micro-organisms (annex III, entry 98). It is not permitted to be used in products used by children under the age of 3 except for shampoos. The Scientific Committee on Consumer Safety opinion on salicylic acid considers salicylic acid to be safe when used as a preservative at a concentration of 0.5%. It also considers salicylic acid to be safe when used at 3.0% in rinse – off hair products and up to 2% in other products when used for purposes other than preservation. However for body lotion, eye shadow, mascara, eyeliner, lipstick and roll on deodorants the Scientific Committee on Consumer Safety considers it is safe up to a maximum concentration of 0.5% only as a preservative. The opinion is not applicable to oral products such as toothpaste and mouthwash and sprayable products which can be inhaled in to the lungs. The Scientific Committee on Consumer Safety opinion applies only to salicylic acid and not to salicylic acid salts or other salicylates.
CMR Omnibus Regulation Annexes III, IV, V and VI of Regulation (EC) No 1223/2009 are lists of substances which can be used in cosmetic products. However some of these substances are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) by Regulation (EC) No 1272/2008 (CLP). It has been the European Commission’s opinion that if a substance is classified as CMR and does not meet the requirements of article 15 of Regulation (EC) No 1223/2009 then it is prohibited regardless of whether it is listed in annexes III, IV, V and VI. This has led to substances continuing to be listed in these annexes even though the European Commission considers them to be prohibited. In 2016 an independent legal opinion was submitted to the European Commission by Cosmetics Europe challenging the European Commission’s
PERSONAL CARE EUROPE
opinion. In response to the legal challenge the European Commission has agreed that substances that are CMR and do not meet the requirements of article 15 should be listed in annex II. The CMR omnibus regulation will remove CMR substances from annexes III, IV, V and VI and list them in annex II. It will also add more substances that are classified as CMR to annex II.
Hypoallergenic claims The Sub–Working Group on Claims4
which
advises the European Commission published guidance on the hypoallergenic claim in 2017. Although not legally binding they gave 1 July 2019 as the date that the guidance should apply from. Hypoallergenic claims should only be made for products which have been designed to minimise the allergenic potential. The responsible person should have scientifically robust and statistically reliable data to verify and confirm that the product has a very low allergenic potential. The assessment of whether a product is hypoallergenic should be done on a continuous basis and reference should be made to post market surveillance data. The hypoallergenic claim does not guarantee the complete absence of risk from an allergenic reaction and products must not give that impression.
‘Free From’ claims The Sub–Working Group on Claims also published guidance on free from claims.4 with hypoallergenic claims the guidance is
As
not legally binding but
should apply from 1 July 2019. It is expected that competent authorities in different member states will apply the guidance in different ways. Some member states intend to implement the guidance fully, other member states intend to incorporate it into their advertising code, and some member states are going to use it just for guidance. Companies should check how competent authorities intend to apply the guidance document in their chosen markets.
Conclusions
This article has looked at how Regulation (EC) No 1223/2009 has been amended in 2018. It has also looked at the decisions of the Scientific Committee on Consumer Safety and how these opinions may lead to the regulation being amended in the future. It has considered how other regulations such as Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP) are also determining how cosmetic ingredients are regulated.
PC
References 1 Regulation (EC) No 1223/2009 Annex III, entry 101 2 SCCS/1595/18 Opinion on Styrene/Acrylates copolymer (nano) and Sodium Styrene/Acrylates Copolymer (nano)
3 SCCP/0918/05, SCCP/1204/08, SCCS/1506/13, SCCS/1500/13 and SCCS/1590/17
4 Technical document on cosmetic claims. Agreed by the Sub-Working Group on Claims (version of 3 July 2017).
April 2019
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