Characterisation report on Cerium dioxide nanomaterials produced by JRC by Nick Boley

The European Commission’s Joint Research Centre (JRC) has published a report detailing the characterisation of two cerium oxide nanomaterials, designated NM-211 and NM-212. These nanomaterials are described as “representative test materials”, so they are not reference materials, but do have a number of properties which enable them to be useful to laboratories wishing to compare their measurements for a range of physico-chemical parameters for nanomaterials. They are therefore of significant value to laboratories wishing the benchmark their measurements in this important field, particularly in advance of the EU definition of a nanoparticle being implemented within the next year.

The characterisation of the materials covered a wide range of properties including particle size. The measurements indicated that these materials exhibited a significant level of aggregation and agglomeration, but the material NM-212 did have a significant population of particles below 50 nm in diameter, with the mean diameter, as determined by Scanning Electron Microscopy (SEM) of 28.4 +/- 10.4 nm.

There was no result report about the number of particles (by mass or number) with one dimension below 100  nm,  so no conclusion could be made regarding whether these materials complied with the proposed EU definition of a nanoparticle.


Amendment to Sulphur in Liquid Fuels Regulations published by Nick Boley

The UK Government has published the Sulphur Content of Liquid Fuels (England and Wales) (Amendment) Regulations 2014 (SI 1975/2014), which amends the Sulphur Content of Liquid Fuels (England and Wales) Regulations 2007 (SI 79/2007).

This amendment, which had previously been enacted in Northern Ireland by the Sulphur Content of Liquid Fuels (Amendment) Regulations (Northern Ireland) 2014 (SR 147), restricts the sulphur content of heavy fuel oils to 1 % by mass, and the sulphur content of gas oils to 0.1 % by mass. It also deletes the previous schedule 8 “technical requirements for sample analysis”. Schedule 6 is amended as follows: “The reference method adopted for determining the sulphur content of fuels sampled pursuant to paragraph (1) shall be defined by ISO method 8754 (2003) or EN ISO 14596 (2007).”

ISO 8754:2003 covers the determination of the sulphur content of fuels by energy-dispersive x-ray fluorescence spectrometry, and has a working range of 0.03 % to 5% sulphur by mass.

EN ISO 14596:2007  covers the determination of the sulphur content of fuels and fuel additives by wavelength-dispersive X-ray fluorescence spectrometry and has a working range of 0.001 % to 2.5 % sulphur by mass.

New CEN Publications – June/July 2014 by Nick Boley
July 28, 2014, 09:21
Filed under: CEN Standards | Tags:

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

EN 12822:2014 – Foodstuffs: Determination of vitamin E by high performance liquid chromatography – Measurement of α-, β-, γ- and δ-tocopherol

EN 14122:2014 – Foodstuffs:- Determination of vitamin B1 by high performance liquid chromatography

EN 14152:2014 – Foodstuffs:- Determination of vitamin B2 by high performance liquid chromatography

EN 14164:2014 – Foodstuffs:- Determination of vitamin B6 by high performance liquid chromatography

EN/ISO 15181:2014 – Paints and varnishes: Determination of release rate of biocides from antifouling paints – Part 6: Determination of tralopyril release rate by quantitation of its degradation product in the extract

EN/ISO 16373-2:2014 – Textiles: Dyestuffs – Part 2: General method for the determination of extractable dyestuffs including allergenic and carcinogenic dyestuffs (method using pyridine-water)

EN/ISO 16373-3:2014 –   Textiles: Dyestuffs – Part 3: Method for determination of certain carcinogenic dyestuffs (method using triethylamine/methanol)

EN 12873-1:2013 – Influence of materials on water intended for human consumption – Influence due to migration – Part 1: Test method for factory-made products made from or incorporating organic or glassy (porcelain/vitreous enamel) materials

CEN/TR 16699:2014 – Foodstuffs: Determination of pesticide residues by GC-MS/MS – Tandem mass spectrometric parameters

EN 12228-1:2014 – Determination of individual and total sterols contents: Gas chromatographic method – Part 1: Animal and vegetable fats and oils

EN/ISO 6974-5:2014 – Natural gas: Determination of composition and associated uncertainty by gas chromatography – Part 5: Isothermal method for nitrogen, carbon dioxide, C1 to C5 hydrocarbons and C6+ hydrocarbons

SCCS Opinions on 4 chemicals published by Nick Boley
July 16, 2014, 07:51
Filed under: chemicals, Cosmetics, EU Information, Uncategorized | Tags:

The European Commission’s Scientific Committee on Consumer Safety (SCCS) has recently published four opinions relating to cosmetic and hair dye products. The products, and the opinions on them, are as follows:

  • Zinc pyrithione which can now be used at concentrations of up to 2.0% in hair products (previously 1.0%)
  • 3-amino-2,6-dimethylphenol which is considered safe for use in oxidative hair dye formulations with an on-head concentration of maximum 2.0%
  • Hydroxyethoxy aminopyrazolopyridine HCl which is considered safe for use in oxidative hair dye formulations with an on-head concentration of maximum 2.0%
  • Basic Brown 17 (8-[(4- Amino-3-nitrophenyl)azo]-7-hydroxy-N,N,N-trimethyl-2-naphthalenaminium chloride) which is considered safe for use in oxidative hair dye formulations with an on-head concentration of maximum 2.0%.



Lack of harmony in chemicals regulation in Europe? by Nick Boley

These posts usually refer to legislation and regulation relating to chemical measurement, and related stories. This one goes in a different direction, and has been prompted by a paper arising from a study carried out by the Swiss Non-Governmental Organisation (NGO) the Food Packaging Forum, as reported recently by Chemical Watch.

The study found that 175 chemicals known to be hazardous to health can be found in food packaging in the EU and the US. Some 21 of these have been recognised by the European Chemicals Agency, ECHA, as being substances of very high concern (SVHCs) and six are actually listed in Annex XIV of REACH to be phased out from use, except by specific authorisation for use. Good examples of this are the chemicals diisobutyl phthalate (DIBP) and 4,4’-methylene-dianiline (MDA). Many other chemicals found in food packaging are considered by the Swedish NGO ChemSec to be hazardous to health, including some which are known, or suspected, to be carcinogenic, mutagenic or endocrine disrupting.

What we can take from this, is that there is no specific regulation to prevent the use of these chemicals in materials which can come into contact with food, there is regulation to restrict or prevent their use electronic equipment, textiles and paints. Whilst we would readily support the use of risk assessment over hazard assessment concerning the use of such chemicals, and the risk of these chemicals leaching from packaging into the food we consume is not proven, logic tells us that there must be a greater risk of these substances getting into the bodies by ingesting these chemicals from foods than by exposure to them if they are present, in very low concentrations, in our mobile phones or computers.

This is, perhaps, an extreme example of where chemicals legislation in Europe appears not to be at all joined-up, with different sectors applying different rules and standards, which are sometimes at odds with each other and occasionally defy logic. Regulations covering the same chemical substances emanating from different Directorates-General of the European Commission where logic would dictate a strong degree of harmony do not show such harmony. This is confusing for consumers, and can increase the risk of exposure to harmful chemicals in some cases. Experts are needed to decide which regulation applies to a specific situation, but why can’t we have a more consistent approach to chemicals regulation, that would be easier for consumers, manufacturers and those tasked with implementing them on a national level to understand?

Drug Driving – Guidance to Healthcare Professionals by Nick Boley

Tough new measures to crack down on the menace of drug driving moved a step closer today after the government issued new guidance to healthcare professionals. The new offence of driving with certain controlled drugs, including some prescription drugs, above specified limits is due to come into force on Monday 2nd March 2015 after the government presented the regulations to Parliament today, Thursday 3rd July. The guidance helps doctors and nurses to start explaining the new rules in advance of the launch and reassure patients who take prescription drugs that they will be able to drive safely without fear of being prosecuted.

The new advice, which has been developed with support from the medical profession, advises general practitioners, doctors, nurses and health advisers on the changes to the drug driving offence and what it means for patients.

Police can already prosecute drivers if they are driving whilst impaired by drugs, including medicinal drugs. The new rules will mean it will be an offence to be over the specified limits for each drug whilst driving, as it is with drink driving. The limits for the majority of medicinal drugs are above the normal doses. Unlike the existing ‘impairment’ offence, the new law provides a medical defence for patients who are taking their medicine in accordance with instructions – either from a healthcare professional or printed in the accompanying leaflet – provided, of course, they are not impaired.

The guidance, therefore, also advises patients who take legitimately supplied medicines to keep evidence with them in case they are stopped by police to help speed up any investigation into the medical defence and reduce the inconvenience to the patient. The new regulations will come into force at the same time as new equipment to test drivers for cannabis and cocaine at the roadside is expected to become available to the police. If a driver is tested positive they will be taken to a police station where a further evidential test will be taken, which, if positive will allow police to prosecute a driver for being over the limit.

The new offence will be introduced alongside major changes to drink-drive laws as part of the Deregulation Bill which will remove the right for drivers who fail a roadside breath test to demand a blood or urine sample at the police station. This test can take place several hours later, which means some drivers who were over the limit when tested at the roadside would have time to sober up. The Deregulation Bill is currently progressing through Parliament and is expected to receive Royal Assent at the end of the year.  New mobile evidential breath testing instruments are also expected to be approved early in 2015 allowing police to take evidential breath tests at the roadside, helping to streamline enforcement and support police officers in making sure our roads are kept safe and free from drink and drug drivers.  2nd March is therefore the most suitable date to bring in all the provisions together. The police support this approach.

The Government Chemist contributed to the consultation process which has resulted in these guidelines and regulations being published. We are particularly interested in the implementation of evidential roadside breath testing devices – which require valid certified reference materials (CRMs) to be used to demonstrate their accuracy –  and of roadside tests for cannabis and cocaine. These will also require CRMs to check their validity and must also be subject to testing to ensure that their performance characteristics are fully understood.

EU May Revise Nanomaterial Definition by Nick Boley
July 3, 2014, 08:54
Filed under: EU Information, EU Regulation/Legislation, Nanomaterials | Tags:

The European Commission’s Joint Research Centre (JRC) has published a report on the draft definition of a nanoparticle which was promulgated in 2011. We have reported previous concerns about the definition.

The report highlights some concerns from industry bodies, who are seeking harmonised definitions across all legislative platforms (REACH, cosmetics, etc) and cite the lack of a single definition as a problem. The need for standardised methods for measuring nanoparticles – both identification and quantification – are also cited as a major issue. The development of robust and validated methods of measurement go hand-in-hand with the development of a nanomaterial definition. Any definition which is adopted must be able to be enforced by appropriate measurement methods, and therefore has to be both objective and feasible, as well as capturing the essence of what a nanomaterial actually is.