— last modified 29 September 2014

The European Commission on 29 September further strengthened the protection of consumers, in particular babies and young children. It adopted two measures restricting the use of three preservatives in cosmetic products.


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The Commission decision follows an assessment by the independent Scientific Committee on Consumer Safety (SCCS), an advisory body which carried out a careful risk assessment of the substances before recommending their restriction or ban.

With the adopted measures the Commission limits the maximum concentration of two preservatives, Propylparaben and Butylparaben, from currently allowed limit of 0.4% when used individually and 0.8% when mixed with other esters, to 0.14%, when used individually or together. They are being banned from leave-on products designed for the nappy area of young children below the age of three since existing skin irritation and occlusion may allow increased penetration than intact skin. The new rules will apply for products put on shelves after 16 April 2015.

Secondly, the Commission bans the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone (MCI/MI) from leave-on products such as body creams. The measure is aimed at reducing the risk from and the incidence of skin allergies. The preservative can still be used in rinse-off products such as shampoos and shower gels at a maximum concentration of 0.0015 % of a mixture in the ratio 3:1 of MCI/MI. The measure will apply for products placed on the market after 16 July 2015.

Background

Preservatives are important in cosmetics as they protect consumers from harmful pathogens that would otherwise invade the creams and products people use on a daily basis. Without preservatives all cosmetics would have a very short shelf life and would, in the most part, have to be stored in a fridge.

The group of chemicals known as parabens make up an important part of the preservatives which could be used in cosmetics. In addition to Propylparaben and Butylparaben, other parabens, like Methylparaben and Ethylparaben, are safe, as repeatedly confirmed by the Scientific Committee on Consumer Safety (SCCS). They are also some of the most efficient preservatives.

Earlier this year, the Commission banned the use of five other parabens in cosmetic products – Isopropylparaben, Isobutylparaben, Phenylparaben, Benzylparaben and Pentylparaben (See Commission Regulation (EU) No 358/2014) due to the lack of data necessary for reassessment. Products placed on the market after 30 October 2014 will have to be free from these substances.

Cosmetic products are regulated at European level through Cosmetic Regulation (EC) No 1223/2009 to ensure consumer safety and the integrity of the internal market. Regardless of the manufacturing processes or the channels of distribution, cosmetic products placed on the EU market must be safe. The manufacturer is responsible for the safety of the products, and must ensure that they undergo an expert scientific safety assessment before they are placed on the market.
Cosmetics regulation on the EU market

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