The EU Commission’s Scientific Committee of Consumer Safety (SCCS) has published the eighth edition of its guidance on testing cosmetic substances and their safety evaluation. The latest version contains updates on alternative test methods.
Although this guidance document is mainly concerned with toxicity testing and, rightly, draws attention to more tests which are an alternative to animal testing, there is also a section (section3.3) on chemical and physical specifications. This section makes clear that the measurement of chemical and physical properties is of great importance in the overall toxicity testing landscape, and highlights the need to do this properly, including aspects such as impurity identification and quantitation, purity, identification, etc.
EFSA, the European Food Safety Authority, has concluded its evaluation of substances which can be used as “previous cargoes” in bulk tanks on tanker vessels, i.e. those which can be used before the tanks are used for the transport of (edible) bulk oils and fats. These are listed in the Annex to Commission Directive 96/3/EC. The review was carried out by EFSA’s CONTAM Panel.
Substances which can no longer be considered as “previous Cargoes” in this context include calcium lignosulphonate, silicon dioxide, carnauba wax, wine lees and montan wax. Those which were considered safe included sodium silicate solution (water glass), iso-octanol, iso-nonanol, iso-decanol, 1,3-propanediol, isobutyl acetate, sec-butyl acetate, tert-butyl acetate, n-butyl acetate, propylene tetramer, paraffin wax, candelilla wax, white mineral oils and glycerol.
The report can be found here.
ECHA, the European Chemicals Agency, will add a further 54 Substances of Very High Concern (SVHCs) to the REACH Candidate List this week. 23 of these were agreed by the Member States Committee (MSC) but the remaining 31 did not require agreement of the MSC. The total number of SVHCs on the Candidate List is now 138 – the original target number for ECHA at this stage of REACH implementation was 136.
For the first time the list contains two substances which are explicitly recognised as endocrine-disrupting chemicals (EDCs) which is a move welcomed by Swedish NGO ChemSec. These two EDCs are nonylphenol and octylphenoletoxilate, which is not only toxic itself but degrades to octylphenol, a homologue of nonylphenol with similar properties. The list also includes three respiratory sensitisers: diazene-1,2-dicarboxamide (ADCA), hexahydro-2-benzofuran-1,3-dione (HHPA) and hexahydromethylphthalic anhydride (MHHPA) as well as Deca-BDE, long identified in the UK as a substance of concern, and a number of perfluorinated compounds.
It will be important for member states to be able to confidently identify these new SVHCs to enforce the regulations effectively.
The European Chemicals Agency (ECHA) has announced that it will publish its dossier evaluation decisions on compliance checks and examination of testing proposals; these will be available on the Agency’s website.
This is an interesting move and follows on from some Non-Governmental Organisations (NGOs) commenting that ECHA’s procedures were not as transparent as the should have been under EU law.
From now on,non-confidential versions of all dossier evaluation decisions originating from compliance checks and examination of testing proposals will be published on the Agency’s website. In most cases they will have a link to the related aggregated registration information as contained in ECHA’s dissemination portal. ECHA will continue publishing available decisions on a regular basis.
This will be a welcome move to many organisations and their responses and comments will prove interesting.
The UK Government has published The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012, which enacts EU Directive 2011/65/EU.
Directive 2011/65/EU lists (in Annex II) the substances which are now not allowed in electrical and electronic equipment, namely:
Lead (0.1 %)
Mercury (0.1 %)
Cadmium (0.01 %)
Hexavalent chromium (0.1 %)
Polybrominated biphenyls (PBB) (0.1 %)
Polybrominated diphenyl ethers (PBDE) (0.1 %)
The new UK regulations come into force on 2 January 2013. Although enforcement is covered in the regulations, no reference is made at all to any measurement and testing procedures which may be needed to enforce the regulations.
Cefic, the European Chemical Industry Council, has published a guidance document on the REACH authorisation process for downstream users.
This guidance is both clear and comprehensive and charts a way through the choppy waters of REACH authorisation that can sometimes be baffling for downstream users who may be far removed from the manufacture and/or importation of chemicals covered by the REACH legislation.
This is a recommended document for anyone wishing to understand and comply with REACH.
Scientists in the USA have developed a new testing approach for evaluating whether chemicals used in common applications such as flame retardants or in household products are likely to be endocrine disrupters (EDCs).
EDCs affect hormone regulation in humans and animals and are considered to be of particular concern at present and possibly responsible for a rise in many conditions including low sperm counts in humans, and fish undergoing gender change.
The new testing system, TiPED (tiered protocol for endocrine disruption) uses a number of testing protocols starting at the most basic level and then getting progressively more complex. Any chemical failing at the first hurdle can the either be redesigned or abandoned.
This system could both reduce the number of animal tests required whilst promoting the need to get an agreed definition of an EDC in Europe.