REGULATIONS 25
Regulatory update for the European Union
Dr Martin Perry – Advanced Development and Safety Laboratories Limited, UK
This article looks at the amendments that have been made to the European cosmetic Regulation (EC) No 1223/2009 in 2018. It also looks at the final opinions of the Scientific Committee on Consumer Safety (SCCS) for 2018. The Scientific Committee on Consumer Safety opinions are a good indicator of how the European cosmetic regulation will evolve in the future.
Commission Regulation (EU) 2018/885
Commission Regulation (EU) 2018/885 amends Regulation (EC) No 1223/2009 for methylene bis-benzotriazolyl
tetramethylbutylphenol a UV filter listed in annex VI (entry 23) and permits its use in nano form (annex VI, entry 23a). Methylene bis-benzotriazolyl tetramethylbutylphenol in nano form can be used up to a maximum concentration of 10% provided it is not in products that can be inhaled in to the lungs. Purity, solubility and median particle size criteria apply to methylene bis- benzotriazolyl tetramethylbutylphenol in nano form. It must also have a partition coefficient (log Pow) of 12.7 at 25°C and be uncoated. If both nano and non nano methylene bis-benzotriazolyl
tetramethylbutylphenol are used in the same formulation the sum of both concentrations must not exceed 10%.
Commission Regulation (EU) 2018/978
Commission Regulation (EU) 2018/978 prohibits the use of Tagetes erecta flower extract and Tagetes erecta flower oil and restricts the use of Tagetes minuta flower extract, Tagetes minuta flower oil, Tagetes patula flower extract and Tagetes patula flower oil to 0.01% in leave-on products and 0.1% in rinse - off products. For Tagetes minuta flower extract, Tagetes minuta flower oil, Tagetes patula flower extract and Tagetes patula flower oil the alpha terthienyl (terthiophen) content must not exceed 0.35% and they must not be used in sunscreen products or products marketed for exposure to natural or artificial UV light. The total combined concentration of Tagetes minuta and Tagetes patula must not exceed 0.01% in leave-on products and 0.1% in rinse- off products. Tagetes erecta flower extract and Tagetes erecta flower oil have been added to annex II (entry 1383). Tagetes minuta flower extract, Tagetes minuta flower oil, Tagetes patula flower extract and Tagetes
patula flower oil have been added to annex III (entries 308 and 309). From 1 May 2019 products placed on the market must comply with this amendment to the regulation and by 1 August 2019 products that do not comply with the regulation must not be available on the market. Tagetes erecta flower extract, Tagetes erecta flower oil, Tagetes minuta flower extract and Tagetes minuta flower oil are used as fragrance ingredients in perfumes.
Commission Regulation (EU) 2018/1847
Commission Regulation (EU) 2018/1847 amends the maximum permitted concentration for the preservative o- phenylphenol (annex V, entry 7) to 0.2% in rinse–off products and 0.15% in leave–on products. The regulation also prohibits the use of MEA o-phenylphenate, potassium o- phenylphenate and sodium o- phenylphenate as preservatives due to their greater skin penetration. From 17 June 2019 cosmetic products placed on the market must comply with this regulation and by 17 September 2019 cosmetic products not complying with this regulation must not be available on the European Union market.
April 2019
PERSONAL CARE EUROPE
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