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.




Eco-labelling criteria for ‘Rinse-off cosmetic products’ established by Nick Boley
December 12, 2014, 11:58
Filed under: Environment/Ecology, EU Information, EU Regulation/Legislation | Tags: ,

The European Commission have published ecological criteria for the award of the EU Ecolabel for rinse-off cosmetic products.

Amongst the criteria listed are substances which may not be included in these products, either as part of the product formulation or as part of any mixture within the formulation.  These substances are:

(i) Alkyl phenol ethoxylates (APEOs) and other alkyl phenol derivatives;
(ii) Nitrilo-tri-acetate (NTA);
(iii) Boric acid, borates and perborates;
(iv) Nitromusks and polycyclic musks;
(v) Octamethylcyclotetrasiloxane (D4);
(vi) Butylated Hydroxy Toluene (BHT);

(vii) Ethylenediaminetetraacetate (EDTA) and its salts and non-readily biodegradable phosphonates;
(viii) The following preservatives: triclosan, parabens, formaldehyde and formaldehyde releasers.
(ix) The following fragrances and ingredients of the fragrance mixtures: Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC), Atranol and Chloroatranol;
(x) Micro-plastics;
(xi) Nanosilver.

This list demands that validated methods are available in accredited laboratories to measure and identify these substances accurately in order to demonstrate compliance. These should be readily available in many cases, but the determination of nanosilver remains a potential problem. It is also important to note that these substances should not be present; we have to understand the limits of detection for these, so we know the maximum concentrations that may be present in compliant products.





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.


Concerns over triclosan safety raised in European Parliament by Nick Boley
January 15, 2014, 18:01
Filed under: Environment/Ecology, EU Information | Tags: , ,

Concerns have been raised over the levels of triclosan, an antibacterial agent, in many common brands of toothpaste. A question in the European Parliament from the Romanian MEP Claudiu Ciprian Tănăsescu (see p391) has highlighted this issue following a move in Denmark to ban toothpastes containing triclosan. The response from the European Commission stated that the permitted maximum level of triclosan in toothpaste of 0.3% is safe.

This limit may well be reduced to 0.2% under the Cosmetics Directive in the future. However, the levels of triclosan in cosmetic products (toothpastes, handwashes, etc) in the UL has already given rise to significant concern, as things currently stand over 450 water bodies in the UK could be in breach of Water Framework Directive (WFD) environmental quality standards (EQS) for triclosan, and these need to be reduced. This was the subject of a presentation from Richard Hawkins of the Environment Agency at a recent meeting of the UK Chemicals Stakeholders Forum (UKCSF). Triclosan is considered to be an endocrine disrupting chemical (EDC), and so this story may keep going for some time.

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.