The European Chemicals agency, ECHA, has published a further guidance document regarding biocides, “Guidance on applications for technical equivalence“.
This Guidance document informs potential applicants about their obligations resulting from the provisions of Article 54 of the Biocidal Products Regulation, when they need to apply for an assessment of technical equivalence and on the procedural steps in making that application. The guidance also informs potential applicants about the assessment process conducted by the Agency and the approach used for assessing the technical equivalence of the alternative source of an active substance versus its reference source.
Technical equivalence is defined in the BPR in Article 3(1)(w): “technical equivalence means similarity, as regards the chemical composition and hazard profile, of a substance….. Therefore, the need to conduct appropriate analytical measurements on the biocidal product, or active ingredient contained therein is of prime importance, alongside establishing the risk from the product.
The document is comprehensive and provides very good guidance to applicants. Similarities to the approaches used previously with REACH are apparent, which is helpful to applicants who have previously registered substances under REACH as well as for consistency of approach for Agency staff.
Filed under: Cosmetics, EU Information, Nanomaterials | Tags: Cosmetics, nanotechnology
The European Commission has published a summary of the Scientific Committee on Consumer Safety (SCCS) opinion on the risks of using nano zinc oxide in sunscreen formulations. This comprehensive document answers many questions about the formulation, safety and use of sunscreens containing nanoparticulate zinc oxide.
One of the more significant conclusions is that formulations containing up to 25 % nanoparticulate zinc oxide are considered safe for use on skin. This would lead to the necessity to be able to measure nanoparticulate zinc oxide in such formulations so that this 25 % threshhold can be monitored. Although there are no such products of this type in Europe at present, this could change in the future.
Filed under: chemicals, ECHA, REACH/CLP | Tags: CLP; REACH; Chemicals; ECHA, Consultation
The European Chemicals Agency, ECHA has received its first application for the authorisation of a chemical under REACH.
Rolls Royce plc have applied for authorisation of bis(2-ethylhexyl) phthalate (DEHP), used in the manufacture of aero engine fan blades. The consultation closes on 9 October.
Authorisations can be granted when a chemical, recognised as being a substance of very high concern (SVHC), is critical in a process for which no alternative chemical currently exists which will do the job to an equivalent standard. Authorisation can be put in place for a set time during which alternatives need to be investigated and, where appropriate, implemented.
This application, being the first, will be studied closely by all relevant organisations – both industry and enforcement bodies – to see how it proceeds and what lessons can be learned.
The European Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), part of the EU’s Joint Research centre (JRC), has launched a consultation on two toxicity testing methods providing an alternative to animal testing.
The two methods are:
- direct peptide reactivity assay (DPRA) for contributing to the assessment of chemicals concerning their potential to cause skin sensitisation; and
- cell transformation assay (CTA) based on the Bhas 42 cell line aiming at predicting the potential of chemicals to cause cancer.
These are not considered as standalone test methods, but as part of an integrated approach to safety assessments for chemicals.
Responses are sought by 13 September 2013, which should be sent to JRC-ECVAM-CONTACT@ec.europa.eu
Filed under: chemicals, ECHA | Tags: CLP; REACH; Chemicals; ECHA, consumer products, PAH, restriction, Toys
The EU has agreed to restrict polyaromatic hydrocarbons (PAHs) in a wide range of consumer products including toys, clothing, footwear, gloves and sportswear, sports equipment, household utensils and tools under the REACH legislation. From November, PAHs will only be allowed in these articles at a maximum concentration of 1.0 mg/kg, although a lower limit of 0.5 mg/kg will apply to toys and childcare products. This restriction was brought in under the “fast-track” process within ECHA, following a submission from the German authorities.
The specific PAHs which will be subject to the restriction are:
- Benzo[k]fluoranthene and
Concerns about this restriction had been raised, particularly regarding the analytical methodology to determine these PAHs, an whether existing methods were sufficiently accurate and sensitive for the purpose. Specific concerns include:
- a lack of clarity on whether the proposed levels are for EACH PAH or TOTAL PAHs
- three of the PAHs listed – benzo(b)fluoranthene, benzo(j)fluoranthene and benzo(k)fluoranthene – are almost impossible to separate using GC-MS, which can lead to major problems accurately quantifying these compounds. In the past, in environmental measurement, the sum of these has been quoted by labs that cannot separate them fully. There are claims of new GC columns which can perform this separation fully, but this is certainly not something which is routine use.
- the actual risk of the PAHs to a child: the extraction procedure in the recommended analytical method extracts PAHs using ultrasonic extraction generating temperatures around 5000K. This does not mimic the conditions of use and how a child handles a toy or other product. Therefore some doubt must be cast on the levels of PAHs which are available by dermal absorption.
This was passed by Qualified Majority Voting with the UK voting against based upon these, and other, concerns.
Some background to this can be found here.
The following list shows standards and technical documents published by the European Standardisation Organisation, CEN, during July 2013, some of which are relevant to chemical measurement in support of regulation.
CEN ISO/TS 16189:2013 – Footwear: Critical substances potentially present in footwear and footwear components – Test method to quantitatively determine dimethylformamide in footwear materials
CEN ISO/TS 16190:2013 – Footwear: Critical substances potentially present in footwear and footwear components – Test method to quantitatively determine polyaromatic hydrocarbons (PAHs) in footwear materials
EN16433:2013 – Cosmetics: Analysis of cosmetic products – Screening for UV-filters in cosmetic products and quantitative determination of 10 UV-filters by HPLC.
EN ISO 3657:2013 – Animal and vegetable fats and oils: Determination of saponification value
EN ISO 3961:2013 – Animal and vegetable fats and oils: Determination of iodine value.
Filed under: chemicals, ECHA, REACH/CLP | Tags: CLP; REACH; Chemicals; ECHA, POPs
The European Chemicals Agency, ECHA, will submit a proposal to restrict bis(pentabromophenyl) ether, more commonly known as DecaBDE. Originally ECHA considered that DecaBDE should be prioritised for an authorisation – allowing use of it in specific situations until a substitute was available. However, it now concurs with the authorities in Norway that DecaBDE should be subject to a restriction, based upon the fact that it should be included in Annex A of the Stockholm Protocol as a Persistent Organic Pollutant (POP).
There have been advances in the analytical measurement techniques used to determine polybrominated diphenyl ethers such as DecaBDE in recent years, including using ICP-MS following chromatographic separation making use of the number of bromine atoms in the compound.