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Cosmetics Law Amendments to Affect Dandruff Hair Products and a Variety of Cosmetics and Personal Care Products

The European Commission has published two texts, one in draft form and the other adopted, each of which has as its aim the amendment of the EU’s framework Regulation on Cosmetic Products (Regulation 1223/2009).

Firstly, the draft Regulation which aims at authorising the use of Zinc Pyrithione for purposes other than inhibiting the development of micro-organisms in rinse-off anti-dandruff hair products was published on 7 September 2016. Hong Kong’s cosmetics exporters may already know that Zinc Pyrithione is currently already authorised in the EU as a preservative in rinse-off hair products at a maximum concentration of 1% and in other rinse-off cosmetic products at 0.5% (excluding oral products), in entry 8 of Annex V to Regulation 1223/2009.

Zinc Pyrithione is also regulated in entry 101 of Annex III to Regulation 1223/2009 for purposes other than inhibiting the development of micro-organisms in leave-on hair products at a maximum concentration of 0.1%.

Some years ago, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (the SCCNFP) was requested to review the safety of Zinc Pyrithione in its function as a non-preservative. Subsequently, the SCCNFP adopted an opinion which concluded that it was safe to use Zinc Pyrithione for non-preservative purposes in cosmetic rinse-off and leave-on hair care products at a maximum concentration of 1.0% and 0.1% respectively. The opinion also concluded that Zinc Pyrithione should not be used in products for oral hygiene.

Thereafter, another safety-oriented EU committee body, namely, the Scientific Committee on Consumer Safety (SCCS) adopted an opinion concluding on the safety of Zinc Pyrithione when used at a concentration up to 2.0% as an anti-dandruff agent in rinse-off hair care products.

In light of these opinions, Zinc Pyrithione should, according to the Commission, be authorised in rinse-off anti-dandruff hair products at a maximum concentration of 2.0% for non-preservative purposes. Therefore, once the draft act is adopted, framework Regulation 1223/2009 will be amended accordingly. It will continue to allow, in its Annex III’s entry 101, Zinc Pyrithione for purposes other than inhibiting the development of micro-organisms in leave-on hair products at a maximum concentration of 0.1%. It will additionally allow rinse-off anti-dandruff hair products to contain Zinc Pyrithione at a maximum concentration (in ready for use preparations) of 2%.

The Commission expects that the proposed date of adoption of the future Regulation will occur in the second or third quarter of 2017. The proposed date of entry into force is then expected to occur 20 days from publication in the EU’s Official Journal.

Please click on the following to view the draft Regulation.

Regarding the other amendment to the EU’s Regulation on cosmetic products, the Official Journal published Commission Regulation 2016/1198 which entered into force on 12 August 2016. This adopted Regulation concerns the use of Methylisothiazolinone in cosmetic products. Methylisothiazolinone has traditionally been used in a wide range of personal care and cosmetic products, including in lotions, moisturisers, sanitary wipes, shampoos and sunscreens.

The new Regulation notes that Methylisothiazolinone is authorised as a preservative in cosmetic products at concentrations up to 0.01% weight by weight (100 ppm) by means of entry 57 of Annex V to Regulation 1223/2009. The Scientific Committee on Consumer Safety (SCCS) adopted an opinion on the safety of methylisothiazolinone (sensitisation only) on 12 December 2013, concluding that current clinical data indicate that the concentration of 100 ppm of methylisothiazolinone in cosmetic products is not safe enough for the consumer.

For leave-on cosmetic products (including so-called “wet wipes”), no safe concentrations of methylisothiazolinone in the field of allergic contact dermatitis have been adequately demonstrated. In light of the SCCS opinion mentioned above, the Commission feels it is important to address the increased incidence of allergies induced by methylisothiazolinone.

As a result, this substance should be banned in leave-on products. Regulation 1223/2009 must therefore be amended accordingly.

However, so as to allow the industry to make the necessary adjustments to product formulations, the application of the above-mentioned ban needs to be deferred. In particular, undertakings are granted six months to place on the market compliant products and to withdraw from the market non-compliant products after the entry into force of the new Regulation.

The Regulation entered into force on the twentieth day following that of its publication in the Official Journal. Thus, from 12 February 2017, only cosmetic products which comply with the new Regulation shall be placed and made available on the Union market.

Please click on the following to view Commission Regulation 2016/1198.

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