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New Class A Drugs listed under Misuse of Drugs Act by Nick Boley
February 24, 2015, 09:11
Filed under: Drugs, Forensics, UK Legislation | Tags: ,

Two new substances have been listed as Class A drugs under the Misuse of Drugs Act 1971. The Misuse of Drugs Act 1971 (Amendment) Order 2015 (SI 215) brings under the permanent control of the Misuse of Drugs Act 1971 a potent opioid known as MT-45 and a synthetic stimulant known as 4,4’-DMAR as Class A drugs under the Act. This legislation is enacted in Northern Ireland by The Misuse of Drugs (Amendment) Regulations (Northern Ireland) 2015 (SR 53).

MT-45 has the systematic IUPAC name of 1-Cyclohexyl-4-(1,2-diphenylethyl)piperazine, and almost all its opioid activity resides in the (S) enantiomer. It is associated with hearing loss and unconsciousness.

MT-45 svg.svg   Structure of MT-45

4,4’-DMAR, or 4,4′-Dimethylaminorex, has the systematic IUPAC name of 4,5-Dihydro-4-methyl-5-(4-methylphenyl)-2-oxazolamine.

44dimethylaminorex structure.png  Structure of 4,4’-DMAR

This so-called “designer drug” is believed to have been responsible for many deaths in the EU over the last few years.

Analytical methods to detect and quantify these two substances must be added to the toolkit of the forensic science laboratories in the UK to properly enforce his new regulation. A reference material of 4,4’-DMAR is available from LGC Standards to help the forensic scientist in this regard. No reference material for MT-45 appears to be available as yet.

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Definitive ruling on SVHC in Articles issue by Nick Boley
February 19, 2015, 09:59
Filed under: chemicals, ECHA, EU Information, REACH/CLP | Tags: ,

The Advocate General to the European Court of Justice, a senior legal advisor, has issued a ruling stating that companies (manufacturers and importers) have an obligation under REACH to report the presence of substances of very high concern (SVHCs) in articles and this applies to all components incorporated into articles, not the whole article. REACH Article 33 states that companies must inform the European Chemicals Agency (ECHA) if an SVHC is present, totalling over one tonne per producer or importer per year, in a concentration higher than 0.1 % by weight.

A number of member states have considered that the obligations under REACH for companies only applied to the whole (e.g. finished) article. A good example of this would be a car, where SVHCs may be found in some specific components at appropriate concentrations, but overall would be significantly lower.

This means that companies in all member states will need to ascertain the levels of SVHCs in all components used in the assembly of any product, which will require a greater breadth of analytical testing in many cases.



Outputs of ECHA Nanomaterials Workshop Available by Nick Boley
February 17, 2015, 16:34
Filed under: ECHA, EU Information, Nanomaterials | Tags: , ,

The presentations given at a nanomaterials workshop held at the ECHA premises in Helsinki in October 2014 are now available on the ECHA website. The workshop, “Regulatory Challenges in Risk Assessment of Nanomaterials”  covered a range of topics, with a wide range of speakers and delegates attending.  One of the themes which emerged from the workshop was that of the need for measurement strategies to be able to identify nanomaterials according to the proposed EU definition: a material with 50 % or more of particles, by number size distribution, having a size between 1 nm-100 nm. This is needed before risk assessments can be carried out, so we know we are dealing with nanoscale materials specifically.

Some information was presented on methods for characterising and measuring nanoparticles which had been carried out under the EU Framework Programme 7 NanoReg 2 project.

It is encouraging to see that work is progressing towards  metrologically-sound methods being developed for characterisation and measurement of nanomaterials, and that attention is being paid to the practical aspects of defining nanomaterials as part of the overall risk assessment and regulatory process.

 

 



Chromium (VI) levels in toys set to be lowered by Nick Boley
February 12, 2015, 10:58
Filed under: EU Information, Toxicology, Toys | Tags: , ,

The European Commission’s Scientific Committee on Health and Environmental Risks (SCHER) has proposed that the levels of  Chromium (VI) available by migration from toys be further lowered.

The proposed values are:

  • 0.0094 mg/kg for scraped-off toy materials;
  • 0.0008 mg/kg for dry, (powder-like or pliable) toy materials; and
  • 0.0002 mg/kg for liquid or sticky toy materials

These values are extremely low, and are in fact below the levels at which chromium (VI) can be measured in the laboratory. Chromium (VI) is a very difficult species to measure, and it is only in recent years that methods capable of separating the more toxic hexavalent form from the more common trivalent form have been developed.
There is a school of thought that instituting a limit value below that which can be measured should not happen and that it would be more sensible to have a limit value equivalent to the best available limit of quantification (LOQ), which can of course be lowered as advances in measurement capability develop.



New Drug Drive legislation for March 2015 by Nick Boley

New legislation which covers the subject of drug driving come into force in the UK on 2 March 2015. This legislation, published by the Department of Transport, aim to improve road safety by setting limits for the levels of 8 illicit drugs and 8 prescriptions drugs in the bloodstream. These are set so that levels above are associated with impairment to drive. The levels for the illicit drugs are very low, but those for the prescription drugs (clonazepam, diazepam, flunitrazepam, lorazepam, oxazepam, temazepam, methadone and morphine) are much higher to reflect average to above-average prescription use so that those drivers keeping to any prescribed dose would be safely below the legal limits.

There is also a proposal to add amphetamine at a level of 250 µg/L to the new legislation – this level is sufficiently high not to catch legitimate users of amphetamine for medical purposes (e.g. those suffering with ADHD).

The Government Chemist responded to a consultation issued in 2014 by the Department of Transport and the response can be accessed here. One of our major concerns is that for legislation like this to be fully effective, measures need to be in place similar to those for drink-driving such as validated roadside tests and certified reference materials (CRMs) to underpin laboratory measurements for drugs in blood. The measurement uncertainties associated with many of these measurements are significantly higher than those associated with alcohol in blood measurements, and these can, in turn, lead to higher uncertainty in the interpretation of results. This is an issue which does, in our opinion, need to be properly resolved for the legislation to have the effect for which it was designed.



New CEN Publications: January 2015 by Nick Boley
February 3, 2015, 12:17
Filed under: CEN Standards | Tags: ,

The following list shows standards and technical documents published by the European Standardisation Organisation, CEN, during December 2014 and January 2015, some of which are relevant to chemical measurement in support of regulation.

CEN ISO/TS 80004-1:2014 – Nanotechnologies – Vocabulary – Part 1: Core terms

CEN ISO/TS 80004-3:2014 – Nanotechnologies – Vocabulary – Part 3: Carbon nano-objects

CEN ISO/TS 80004-4:2014 – Nanotechnologies – Vocabulary – Part 4: Nanostructured materials

EN 15063-1:2014 – Copper and copper alloys – Determination of main constituents and impurities by wavelength dispersive X-ray fluorescence spectrometry (XRF) – Part 1: Guidelines to the routine method

EN 16568:2014 – Automotive fuels – Blends of Fatty acid methyl ester (FAME) with diesel fuel – Determination of oxidation stability by rapidly accelerated oxidation method at 120 °C