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Cosmetic Regulation 1223/2009/EC came into force on 11 July 2013 and replaced Council Directive 76/768/EEC. With its enhanced focus on product safety, the recall figures from RAPEX, the EU’s rapid alert system for highlighting dangerous non-food products that may pose a risk to consumers, offer an insight into the new regulation’s impact on recall volumes and causes.

Tighter product safety following implementation of Cosmetics Regulation 1223/2009/EC, incorporates the latest technological developments, an enhanced safety assessment, consideration of the potential use of nanomaterial, as well as a new amendment on the use of preservatives.

In a study of data, from July 2013 to November 2014, RAPEX identifies nine recall categories since the Regulation came into force. These are:

  • Heavy metals – 31%
  • Preservatives – 20%
  • Microbiological content – 18%
  • Prohibited substances – 13%
  • Hydroquinone – 8%
  • Methyl Methacrylate (MMA) – 3%
  • Hydroxide/Monomers/Acid – 3%
  • Phthalates – 3% 
  • Hydrogen peroxide – 1%

Used in a range of products, the incidence of these substances highlights issues with raw materials, and the quantities in which they are added/ blended to the final product.

Heavy metals

37 cosmetics products were reported and recalled due to the detection of high levels of heavy metals, including mercury, antimony, lead, cadmium and chromium. Skin lightening and nail products are those most commonly reported. Of the 37 recalls in this category, two products contained high levels of Barium.

Preservatives

Three preservatives, present in excessive levels, account for some 20% of all cosmetic product recalls:

  • Formaldehyde: mostly in hair products. The Cosmetics Regulation permits 0.1% of formaldehyde in oral cosmetics and 0.2% in all other products, for use as a preservative. For any other purpose, formaldehyde is permitted at a maximum concentration of 5% in the finished cosmetic product.
  • Iodopropynyl Butylcarbamate (IPBC): IPBC is not permitted for use in children’s leave-on products, deodorants or antiperspirants. Wet wipe products are frequently recalled due to higher than permitted IPBC levels.
  • Methylisothiazolinone (MIT) and Methylchloroisothiazolinone (CMIT): the presence and levels of these two preservatives is frequently checked by member states. Amendment 1003/2014/EC, published in September 2014, further restricts the use of MIT and CMIT mixtures.

Microbiological Content

19% of products recalled, are failed on microbiological quality.

Hydroquinone & Hydrogen Peroxide

Skin lightening products have been recalled due to the presence of hydroquinone, which is a prohibited substance (except for professional use of artificial nail systems). In addition, a teeth whitening product was reported to contain hydrogen peroxide.

Methyl Methacrylate

Half of all recalled nail products contained concentrations of more than 90% of methyl methacrylate (MMA) in the finished product. MMA is classified as hazardous to health within Article 3 of the Cosmetics Regulation. Also, the German Federal Institute for Risk Assessment (BfR) in its opinion 014/2012 classifies concentrations of 80-90 % methyl methacrylate in nail art substances as hazardous to health.

Hydroxide, Monomers & Acid

Some products were reported to pose a risk of skin problems after use, due to the presence of large quantity of hydroxide, acrylate monomers, or weak acid (e.g. lactic acid).

Phthalates

All phthalate recalls related to nail products, which use them as plasticisers to increase flexibility and prevent dried nail polish from cracking easily. However, its carcinogenicity and toxicological profile make it unsafe to use.

Other restricted substances

A number of cosmetic products were recalled and reported during this period, due to the presence of restricted substances, including clobetasol propionate, m-phenylenediamine and para-phenylenediamine.

Avoid unnecessary recalls

SGS is experienced in enabling organisations to demonstrate their compliance with the EU Cosmetics Regulation. We conduct product testing (physical, chemical, microbiological and ecotoxicological/biodegradability) and safety assessments (Cosmetic Product Safety Report, CPSR) to help you ensure the delivery of safe products and minimise the risk of non-compliance and costly recalls. With a network of experts and testing facilities across the EU, America and Asia, SGS is the partner to trust.

For more information, please visit SGS Cosmetics and Personal Care or contact:

Queenie Tse
Global Technical Support
Cosmetics, Personal Care and
Household
SGS Hong Kong
t: +852 2765 3672 ext. 1672

Related safeguards

Read the latest Safeguards, published by SGS, relating to cosmetic products: