Filed under: chemicals, EU Information, Toys | Tags: chemicals, safety assessments, Safety Data Sheets, Toys
The European Commission has published a new Guidance Document on the safety assessment of toys to enable manufacturers carry out safety assessments of toys according to their obligations under the Toy Safety Directive.
The guidance document is comprehensive and covers all aspects of safety assessments which are appropriate under the Directive. There is a significant section on chemical safety assessments which includes sections on the hazardous chemicals which may be found in toys for which assessments must be carried out, and how this can be achieved. Worked examples are given which will help manufacturers comply with the Directive more easily.
Filed under: ECHA, REACH/CLP | Tags: CLP; REACH; Chemicals; ECHA, Downstream Users, REACH, Safety Data Sheets
The European Chemicals Agency, ECHA, has published two further shortened versions of its REACH guidance documents in the Guidance in a Nutshell series.
The two documents are:
- Safety Data Sheets, which covers important topics including which products do or do not require a Safety Data Sheet (SDS), what information has to be included in an SDS, and the format of an SDS.
- Downstream Users, which covers important topics including the obligations of downstream users (DUs) under REACH, and communications along the supply chain.
These two topics may appear peripheral to the effective operation of the REACH legislation, but are important in the overall process. There is some evidence that downstream users are not always fully engaged with the REACH process and so this guidance should help to begin to address this situation.
Filed under: EU Information, EU Regulation/Legislation, Nanomaterials | Tags: foods, nanotechnology, regulation
The European Commission has published a regulation, Commission Delegated Regulation No 1363/2013, which amends Regulation 1169/2011 pertaining to nanomaterials in foods.
The new regulation states that food labelling must list “engineered nanomaterials” in the list of ingredients. These could be, for example, calcium carbonate, titanium dioxide, silicon dioxide or silver. The definition of what constitutes a nanomaterial is that previously given by a Commission Recommendation in 2011, so there is consistency across sectors. Work has been ongoing in a number of organisations, including LGC, to develop definitive methods for identifying and quantifying nanomaterials according to this definition.
The main thing to note here is the term “engineered nanomaterials”. This applies to nanomaterials which have been deliberately produced, so that the regulation excluded naturally-occurring nanomaterials which have been present in our food for thousands of years.
UPDATE: The Commission has now stated that this Regulations should be considered null and void. I will endeavour to find out why and blog on that when I do.
The following list shows standards and technical documents published by the European Standardisation Organisation, CEN, during November 2013, some of which are relevant to chemical measurement in support of regulation.
CEN ISO/TS 17919:2013 – Microbiology of the food chain – Polymerase chain reaction (PCR) for the detection of food-borne pathogens – Detection of botulinum type A, B, E and F neurotoxin-producing clostridia (ISO/TS 17919:2013)
EN 12391 Part 1:2013 – Foods of plant origin – Multiresidue methods for the determination of pesticide residues by GC or LC-MS/MS – Part 1: General considerations
EN 12391 Part 2:2013 – Foods of plant origin – Multiresidue methods for the determination of pesticide residues by GC or LC-MS/MS – Part 2: Methods for extraction and clean-up
EN 12391 Part 3:2013 – Foods of plant origin – Multiresidue methods for the determination of pesticide residues by GC or LC-MS/MS – Part 3: Determination and confirmatory tests
The European Chemicals Agency, ECHA, has announced that a further seven chemicals have been added to the candidate list of substances of very high concern (SVHCs) to be potentially restricted under the REACH regulations.
The seven chemicals are:
- Cadmium sulfide
- Disodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate) (C.I. Direct Red 28)
- Disodium 4-amino-3-[[4′-[(2,4-diaminophenyl)azo][1,1′-biphenyl]-4-yl]azo] -5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate (C.I. Direct Black 38)
- Dihexyl phthalate
- Imidazolidine-2-thione (2-imidazoline-2-thiol)
- Lead di-acetate
- Trixylyl phosphate
The proposed restriction applies to the chemicals themselves plus articles containing them at a concentration above 0.1%, if traded in sufficient quantity.
Filed under: chemicals, ECHA, REACH/CLP | Tags: CLP; REACH; Chemicals; ECHA, SVHCs
ECHA, the European Chemicals Agency, has published an implementation plan for its roadmap for substances of very high concern (SVHCs) to 2020. The roadmap itself can be found here.
The plan gives priority to substances with SVHC properties which are registered for non-intermediate uses within the scope of authorisation such as:
- carcinogenic, mutagenic and reprotoxic substances (CMRs)
- endocrine disrupting chemicals (EDCs)
- persistent and bioaccumulative substances (PBTs)
The European Commission has published a target of having all known SVHCs included on the REACH Candidate List by 2020, which is a very challenging task. Once SVHCs have been identified and their toxicity established, monitoring will need to be carried out to ensure that Regulations are being complied with. Methods for the identification of these substances, for their extraction and measurement in articles, as well as unambiguous nomenclature, will be needed to ensure that the Regulations can be effectively enforced.
Filed under: chemicals, EU Information, EU Regulation/Legislation | Tags: chemicals, Drug precursors
The European Parliament and the Council of Ministers have agreed a proposal from the Commission on control of drug precursors, and have issued a Regulation to implement this.
The Regulation, 1258/2013, adds acetic anhydride to the list of drug precursors controlled by Regulation 273/2004. Acetic anhydride is used in the production of illicit heroin (diamorphine).
In a parallel move, the European Parliament and the Council of Ministers have also agreed a proposal from the Commission on monitoring the trade between the EU and third countries in drug precursors. Regulation 1259/2013 adds medicinal products and veterinary medicinal products containing ephedrine or its salts, and pseudoephedrine or its salts to the list of products to be monitored. These substances can be used in the production of illicit drugs, including amphetamines, alongside their legal uses.