The European Commission has produced a draft delegated directive which have the effect of adding four phthalates to the list of substances proscribed under the Restrictions of Hazardous Substances (RoHS2) Regulation. The maximum permitted concentration of these would be 0.1 % by weight.
The four phthalates are:
- Diethylhexyl phthalate (DEHP)
- Benzyl butyl phthalate (BBP),
- Dibutyl phthalate (DBP), and
- Di-isobutyl phthalate (DiBP)
All of these are commonly used as plasticisers in electrical cabling. These substances are readily measured using high performance liquid chromatography (HPLC), but laboratories would need to ensure they can measure accurately at the 0.1% level so that compliant and non-compliant materials can easily be differentiated.
If there is no objection to the proposal from member states, this will come into force within 2 months and would have to be adopted by member states by the end of 2016.
Filed under: EU Regulation/Legislation, REACH/CLP, Toys | Tags: lead, REACH, regulation
The European Commission has adopted a new restriction under the REACH Regulation which covers lead in consumer items which “during normal or reasonably foreseeable conditions of use, be placed in the mouth by children.”
The Regulation, 2015/628, restricts the placing on the market of consumer items containing 0.05 % lead, by weight, overall or in those parts accessible to children unless it can be demonstrated that the rate of lead release from such an article or any such accessible part of an article, whether coated or uncoated, does not exceed 0.05 μg/cm2 per hour (equivalent to 0.05 μg/g/h), and, for coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the article.
Enforcement of this Regulation depends upon the more subjective assessment of whether normal conditions of use would endanger children by the placing of the items in the mouth, as well as the more objective measurement of the lead content, which should not prove a significant issue for any competent laboratory accredited for such tests.
Filed under: Allergies, EU Regulation/Legislation | Tags: allergens, Food labelling, foods
A fit and healthy 22-year-old girl collapses suddenly after eating a cake and is rushed to hospital. She spends three days in intensive care and five more days in hospital recovering. Poison might have been suspected but there is no investigation for attempted murder. The culprit is caught but walks free from court with just a £7,500 fine.
You may find this shocking, but this was a real UK court case in 2010. The poison: peanuts. The charge: selling falsely labelled food.
In a comment article in the latest issue of Chemistry and Industry magazine (13 March 2015), Michael Walker, Consultant Science Manager for the Government Chemist, and Hazel Gowland, from Allergy Action, discuss this court case as part of a recent review they carried out examining court cases in the UK involving fatalities, personal injury, or criminal non-compliance with food law.
The article outlines the role businesses must play in protecting people with food allergies and the need for tough sanctions if they fail in their duty. They explain the difficulties in detecting the presence of allergenic proteins in foods and why techniques for measuring allergens need to be standardised.
Visit the Chemistry and Industry website to access a copy of the article.
Filed under: Environment/Ecology, EU Regulation/Legislation, Plant Protection | Tags: endocrine disrupters, PBTs, regulation
The European Commission has published a Regulation which details those active substances in plant protection products should be considered in the future to be substituted in view of their potentially toxic properties.
Commission Implementing Regulation 2015/408 lists a significant number of active substances which are considered to either be persistent, bioaccumulative and toxic (PBTs) or have endocrine-disrupting properties (EDCs).
The regulation comes into force on 1 August 2015, and has implications for laboratory measurements as this range of substances – which covers many different classes of chemical, both inorganic and organic, to be identified and measured in order to ascertain if they are present in any plant protection product.
Filed under: chemicals, EU Regulation/Legislation, RoHS/WEEE | Tags: endocrine disrupters, regulation
The European Commission has advised the World Trade Organisation (WTO) of its intention to include the four phthalates DEHP, BBP, DBP and DiBP to the list of restricted substances under the Restriction of Hazardous Substances in electrical and electronic devices legislation. These substances are considered by some to be endocrine disrupters (EDCs), although there is not general agreement across Europe on this.
The proposed restriction is due to be implemented in 2019, although will not apply to medical devices and monitoring and control instruments until 2021.
Filed under: chemicals, Environment/Ecology, EU Regulation/Legislation, Waste | Tags: Environmental, POPs
The European Commission have published a new regulation, 1342/2014, which adds limit values to a number of persistent organic pollutants (POPs) listed in the Stockholm Convention. The POPs concerned are: chlordecone, hexabromobiphenyl, hexachlorocyclohexanes, including lindane, pentachlorobenzene, tetrabromodiphenyl ether, pentabromodiphenyl ether, hexabromodiphenyl ether and heptabromodiphenyl ether, and perfluorooctane sulfonic acid and its derivatives.
These are for articles, where the values are between 15 µg/kg for dioxins and furans, to 50 mg/kg for many other POPs.
Validated analytical methods need to be in place to ensure that this can be enforced, and the limits are such that this is not an issue.
Filed under: Environment/Ecology, EU Information, EU Regulation/Legislation | Tags: Cosmetics, testing
The European Commission have published ecological criteria for the award of the EU Ecolabel for rinse-off cosmetic products.
Amongst the criteria listed are substances which may not be included in these products, either as part of the product formulation or as part of any mixture within the formulation. These substances are:
(i) Alkyl phenol ethoxylates (APEOs) and other alkyl phenol derivatives;
(ii) Nitrilo-tri-acetate (NTA);
(iii) Boric acid, borates and perborates;
(iv) Nitromusks and polycyclic musks;
(v) Octamethylcyclotetrasiloxane (D4);
(vi) Butylated Hydroxy Toluene (BHT);
(vii) Ethylenediaminetetraacetate (EDTA) and its salts and non-readily biodegradable phosphonates;
(viii) The following preservatives: triclosan, parabens, formaldehyde and formaldehyde releasers.
(ix) The following fragrances and ingredients of the fragrance mixtures: Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC), Atranol and Chloroatranol;
This list demands that validated methods are available in accredited laboratories to measure and identify these substances accurately in order to demonstrate compliance. These should be readily available in many cases, but the determination of nanosilver remains a potential problem. It is also important to note that these substances should not be present; we have to understand the limits of detection for these, so we know the maximum concentrations that may be present in compliant products.