Filed under: EU Regulation/Legislation, REACH/CLP | Tags: extender oils, PAH, REACH, testing
The European Commission has notified the World Trade Organisation that it plans to amend Annex XVII of REACH to include a standard analytical method for the restriction of polycyclic aromatic hydrocarbons (PAH). The method should be used to determine the PAH content of extender oils used in the production of tyres or parts of tyres to ensure compliance with the Regulation as defined in the current restriction.
The new reference analytical method is European standard EN 16143:2013, which replaces the IP method IP-346 which will now be removed from the restriction. The IP method was not considered suitable for all sample types which may need to be analysed.
The current limit for PAHs in extender oils is 1 mg/kg for benzo(a)pyrene or 1o mg/kg total of the 8 named individual PAHs (benzo(a)pyrene, benzo(e)pyrene, benzo(a)anthracene, chrysene, benzo(b)fluoranthene, benzo(j)fluoranthene, benzo(k)fluoranthene and dibenzo(a,h)anthracene.
The new standard method involves a double liquid chromatography (LC) clean-up stage and quantitation of the individual PAHs by gas chromatography-mass spectrometry (GC-MS). Correlation of this type of procedure with IP-346 (on sample matrices where it works well) has been good and, although the new CEN method is more expensive to use, it is more applicable and will give better results across the range of matrices which will be encountered. This makes it a far more suitable procedure for enforcement and monitoring of the regulation.
The results of the EU-wide testing programme for pesticide residues in foods has been published by the European Food Safety Authority (EFSA). The results cover the (then) 27 EU Member States plus Norway and Iceland. The report shows that over 79,000 samples of all different types of food were analysed by national authorities and, of these, 97.5% were below the maximum residue levels (MRLs) set for each pesticide, with the figure for the UK being 99 %. The food type with the highest non-compliance rate in the UK was spinach.
The measurement methods used to conduct these surveys are all validated, accredited procedures carried out by expert laboratories. In case of any dispute over pesticide levels in the United Kingdom, the Government Chemist can act as referee under the terms of the Agriculture Act 1970.
Filed under: EU Regulation/Legislation, RoHS/WEEE | Tags: lead, mercury, WEEE/RoHS
A series of exemptions to Directive 2011/65/EU – the Restrictions on the use of Hazardous Substances (RoHS) Directive – have been published by the European Commission.
These exemptions, which cover uses of lead and mercury in electrical and electronic equipment placed on the market within the EU, allow for these toxic metals to be used in specific applications as no feasible substitutes for their use have yet been developed.
The series of Commission Delegated Directives – numbered from 2014/69/EU to 2014/76/EU allow for the following uses of these metals:
- lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC for industrial monitoring and control instruments
- lead in micro-channel plates (MCPs)
- lead in solder in one interface of large area stacked die elements
- lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems
- lead in platinized platinum electrodes used for conductivity measurements
- lead used in other than C-press compliant pin connector systems for industrial monitoring and control instruments
- mercury in cold cathode fluorescent lamps (CCFLs) for back-lighting liquid crystal displays, not exceeding 5 mg per lamp, used in industrial monitoring and control instruments placed on the market before 22 July 2017
- mercury in hand crafted luminous discharge tubes (HLDTs) used for signs, decorative or architectural and specialist lighting and light-artwork
The exemption for mercury in cold cathode fluorescent lamps (Commission Delegated Directive 2014/75/EU) is of particular interest as it includes a quantitative limit which can not be exceeded. The accurate determination of mercury is still challenging for many analytical laboratories, and this may be an area where the development of a Certified Reference Material for mercury in such products is needed to assist manufacturers and regulatory laboratories enable this level not to be exceeded.
Filed under: EU Regulation/Legislation, Food and Feed | Tags: foods, sampling, statistics, toxins
The European Commission has published a new regulation, Commission Regulation 519/2014, which amends Regulation (EC) No 401/2006 regarding sampling of large lots, spices and food supplements, performance criteria for T-2, HT-2 toxin and citrinin and screening methods of analysis.
This is a detailed Regulation, which lays down sampling regimes for the determination of mycotoxins in foods and feeds. It also details the method performance characteristics which should apply for some analytical methods used for the determination of mycotoxins in various food and feed matrices, including detailed statistical protocols which should be followed.
This is a substantial Regulation covering important aspects of sampling and analysis, and should be read by all professionals working in this field.
Filed under: EU Information, Nanomaterials | Tags: definition, measurements, nanotechnology
The European Commission has published a new report written by experts at the EU’s Joint Research Centre (JRC) in Ispra (Italy), entitled “Towards a review of the EC Recommendation for a definition of the term “nanomaterial”: Part 1: Compilation of information concerning the experience with the definition”.
This comprehensive and lengthy report (it runs to some 288 pages) covers a great deal of ground. Specifically it considers how the recommended definition of nanomaterial is used in the EU, and how it differs from other definitions. It also takes a very deep look at the methods of measurement which are available to potentially enforce a definition, their resource implications and the strengths/weaknesses and applicability of the various techniques.
Subsequent reports – this is the first of a series of three – will provide an assessment of the EC nanomaterial definition and the issues compiled in this first report, in relation to the objective of reviewing the current EC definition, and the third report will provide recommendations to improve content and the implementation of the EC Definition as well as related communication aspects.
The European Commission has published a Delegated Regulation, 492/2014, which covers the renewal of national authorisations for biocidal products under the Biocidal Products Directive, having been previously subject to mutual recognition.
This requires, amongst other things, applicants to provide “a draft summary of the biocidal product characteristics containing the information required under Article 22(2) of Regulation (EU) No 528/2012, in the official languages of the reference Member State and of the Member States concerned which, where relevant, may differ between Member States in accordance with Article 1(3) of this Regulation”, which would include identification of the biocidal active substance(s), and all relevant compositional data. If data is to be recognised by mutual recognition, we would expect that the methodology used to produce such data be produced using an accredited test method, which would be recognised across all signatories of the ILAC convention.
The European Standards Organisation, CEN, has published a new version of EN standard on Safety of toys – EN 71 Part 7: Finger paints – Requirements and test methods.
This new version (EN 71-7:2014) brings the requirements for finger paints up to date with respect to the EU Toy Safety Directive and the requirements of the REACH Regulations.
Specific changes of interest include a revised limit value for the carcinogenic polynuclear aromatic hydrocarbon (PAH) benzo[a]-pyrene, which is set at the limit of quantitation of the analytical method used, 0.02 mg/kg. This is a welcome development, where the limits in the standard are in line with what can be achieved with the state-of-the-art of analytical measurement capability. We highlighted last year the restrictions under REACH for PAHs in toys, and this new standard recognises that development. The addition of limit values for polychlorinated biphenyls (PCBs) is another welcome development, and a valid measurement method for PCBs is included in the standard.