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Proposed Changes to Regulations Governing Allergenic Substance in Cosmetic Products

The Danish Environmental Protection Agency has called for an EU-wide ban on the use of Methylisothiazolinone (MI) in cosmetic products, and for products containing the substance to be labelled clearly with allergy warnings. MI acts as a preservative in cosmetic products and is authorised under Annex V of Regulation 1223/2009 (the Cosmetics Regulation) at a maximum concentration of 0.01% or 100 parts per million. It is also used in other personal care products such as sunscreens and shampoos.

Studies have shown that sensitisation, allergic reactions, and cell and nerve damage are increasingly becoming a problem all over Europe.

The European Union’s Scientific Committee on Consumer Safety (SCCS) has found that the current authorised concentration of 100 ppm of MI in cosmetic products is not safe. For cosmetic products that can be rinsed off, a concentration of 15 ppm is considered to be safe; a safe concentration of MI for leave-on cosmetic products has not been established. 

Information regarding the presence of MI in products other than cosmetics or household cleaners is not readily available yet because there is no harmonised classification of MI as a skin sensitizer. Other products that contain MI, such as paint, varnish, adhesives, and cleaning products should also be assessed because of their contribution to human exposure to MI.

The SCCS is expected to publish an opinion regarding the risk of MI in rinse-off and hair leave-on products by the end of September 2015. The Commission will wait for the results of this assessment before reducing the authorised concentration of MI in these products from 100 ppm to 15 ppm.

The Commission proposes to ban MI in leave-on products, while providing industry with a short transitional period allowing time to place compliant products on the market and remove non-compliant products, and to amend entry 57 of Annex V to Regulation 1223/2009. Annex V lists the types of preservatives that are allowed in cosmetic products.

On 29 July 2015, the Commission opened a public consultation on MI. The Commission would like to invite any interested parties, including authorities of the Member States, manufacturers of cosmetic products, producers of the substances concerned and relevant industry and consumers associations, to submit their comments on the proposed measures and on their possible economic impact.

The Commission requests that the information or comments refer to:

  • the feasibility of the proposed changes,
  • competitiveness, markets and trade,
  • direct and indirect costs,
  • innovation and research, 
  • specific regions, sectors or workers,
  • third countries and international relations, and
  • the macroeconomic environment.

The deadline for submissions is 23 October 2015, and submissions can be emailed to grow-cosmetics-and-medical-devices@ec.europa.eu.

Hong Kong and mainland Chinese producers and sellers of products containing MI on the EU market may want to take note of these proposed changes, and contribute to the public consultation regarding MI’s effects.

Furthermore, they may also want to follow the progress of the Commission’s assessment and be aware of any amendments to the Cosmetics Regulation that may happen as a result. Should the Cosmetics Regulation be amended, producers and sellers in Hong Kong should ensure that their products are compliant with the new Regulations.

More information regarding the public consultation can be found on the Commission’s website.

Content provided by Picture: HKTDC Research
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