governmentchemist


REACH restriction submitted on D4/D5 in personal care products by Nick Boley

The UK authorities have submitted their application to CHA for a restriction under REACH on the use of the cosmetic ingredients D4 (octamethylcyclotetrasiloxane) and D5 (decamethylcyclopentasiloxane) in wash-off personal care products. The proposal asks that an upper limit of 0.1% applies to each of these.

These can be determined analytically by gas chromatography-mass spectrometry (GC-MS). A further siloxane in this family, D6 (dodecamethylcyclopentasiloxane), is frequently found in mixtures with D4 and D5, but is not included in the scope of this restriction application.

 



Data sought by European Commission on nano ingredients in cosmetics by Nick Boley
March 31, 2015, 08:24
Filed under: Cosmetics, EU Information, Nanomaterials | Tags: , ,

The European Commission has asked for more detailed toxicity data on three nano ingredients which are quite commonly used in cosmetics.

The three substances are:

  • nano collodial silver;
  • nano styrene/acrylates copolymer; and
  • nano sodium styrene/acrylates copolymer.

Nano colloidal silver is used as an antimicrobial, has a lowest cut off particle size of 1 nm and a maximum concentration up to 1.0 % in cosmetic products. Although the toxicity data needs to be more detailed, there is still a difficulty in accurately characterising and measuring the concentration of nano-colloidal silver, with robust validated methods not being available.

Similar problems exist for the nano-forms of the two copolymers.

 

 



Two amendments to EU Cosmetics Regulations published by Nick Boley
September 26, 2014, 09:53
Filed under: Cosmetics, EU Regulation/Legislation | Tags: , ,

The European Commission have published two amendments to the EU Cosmetics Regulations (Commission Regulation 1223/2009) which change the levels of certain preservatives in cosmetics.

Commission Regulation 1003/2014 specifies that from July 2015 cosmetics products can only be placed on the market if they contain a maximum of 0.0015 % of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one).  In addition, 2-Methyl-2H-isothiazol-3-one is only permitted at a maximum concentration of  0.01 %.

Commission Regulation 1004/2009 specifies that from July 2015 cosmetics products can only be placed on the market if they contain a maximum of 0.4% (single ester) or 0.8 % (mixture of esters) of 4-Hydroxybenzoic acid and its Methyl- and Ethyl- esters, and their salts. Additionally, 4-Hydroxybenzoic acid and its Methyl- and Ethyl- esters, and their salts, have a maximum concentration of 0.14 % (as acid) as the sum of all compounds under this definition.



SCCS Opinions on 4 chemicals published by Nick Boley
July 16, 2014, 07:51
Filed under: chemicals, Cosmetics, EU Information, Uncategorized | Tags:

The European Commission’s Scientific Committee on Consumer Safety (SCCS) has recently published four opinions relating to cosmetic and hair dye products. The products, and the opinions on them, are as follows:

  • Zinc pyrithione which can now be used at concentrations of up to 2.0% in hair products (previously 1.0%)
  • 3-amino-2,6-dimethylphenol which is considered safe for use in oxidative hair dye formulations with an on-head concentration of maximum 2.0%
  • Hydroxyethoxy aminopyrazolopyridine HCl which is considered safe for use in oxidative hair dye formulations with an on-head concentration of maximum 2.0%
  • Basic Brown 17 (8-[(4- Amino-3-nitrophenyl)azo]-7-hydroxy-N,N,N-trimethyl-2-naphthalenaminium chloride) which is considered safe for use in oxidative hair dye formulations with an on-head concentration of maximum 2.0%.

 

 



EU revises triclosan limits in some cosmetics by Nick Boley

The European Commission has published a regulation, 35/2014, which amends Annexes II and V to Regulation (EC) No 1223/2009, covering cosmetic products.

The Scientific Committee on Consumer Products (SCCP) considered that the continued use of triclosan as a preservative at the current maximum concentration limit of 0.3 % in all cosmetic products is not safe for the consumer because of cumulative exposure effects. However, they considered that its use at a maximum concentration of 0.3 % in toothpastes, hand soaps, body soaps/shower gels and deodorants, face powders and blemish concealers is safe. In addition, the Scientific Committee on Consumer Safety (SCCS) considered that other uses of triclosan –  in nail products where the intended use is to clean the fingernails and toenails before the application of artificial nail systems at a maximum concentration of 0.3 % and in mouthwashes at a maximum concentration of 0.2 % are safe for the consumer.

It has been previously reported that there are currently over 450 water bodies in the UK which are in excess of the maximum triclosan levels according the EU’s Water Framework Directive, and reductions in levels of this preservative in widely-used consumer and cosmetic products are necessary if this is to be remedied.

 



New EU Guidelines on Cosmetic Product Safety by Nick Boley
November 26, 2013, 12:15
Filed under: Cosmetics, EU Information, EU Regulation/Legislation | Tags: ,

The European Commission has published a Commission Implementing Decision which provides Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.

The guidelines make it clear what the obligations of manufacturers and importers of cosmetic products are, and what should be contained within the Cosmetic Product Safety Report. In particular, the following should be noted:

  • Section 3.1. states that the quantitative and qualitative composition of the product should be provided, including details on each component, whether a raw material, mixture, well-defined substance, etc.
  • Section 3.2 requires that the physical/chemical characteristics and stability of the cosmetic product are given. This includes properties such as molecular weight, solubility and purity. Furthermore, particle size distribution information, especially for nanomaterials, should be provided.
  • Section 3.4 requires that information on whether the cosmetic product contains substances that have not been intentionally added to the formulation, and which may have an impact on its safety, are present.

It can be seen from these guidelines that manufacturers or companies trading in these products, need to have access to high quality analytical testing facilities to cover the range of issues highlighted. These facilities should, ideally, be covered by ISO/IEC 17025 accreditation so that data produced is accepted across borders.



Regulation on Cosmetic Products Amended by Nick Boley
November 26, 2013, 11:17
Filed under: Cosmetics, EU Regulation/Legislation | Tags: ,

The European Commission has issued an amendment to the Regulation on cosmetic products (1223/2009) having considered opinions published by the Scientific Committee on Consumer Safety (SCCS).

The amendment, published as Commission Regulation 1197/2013, specifically addresses the issues of the maximum allowable concentrations of certain substances in hair dyes, and also states that certain substances currently considered as safe for hair applications are also safe for use on eyelashes.

Many of these substances are allergens for a small percentage of the European population, and labels warning that products contain allergens must be used.