United Kingdom
Nonylphenol
Draft regulations on transposing an EU Directive relating to restrictions on the marketing and use on nonylphenol, nonylphenol ethoxylates and cement (2003/53/EC) have been published for consultation. This directive is the 26th amendment to the Directive harmonising controls on the marketing and use of dangerous substances throughout member states (76/769/EEC). It is designed to restrict the placing on the market and use of these compounds in order to decrease discharges, emissions and losses to the environment. The provisions in the Directive relating to cement are being dealt with separately by HSE. The Directive has to be transposed in the UK by 17 January 2005. Nonylphenol is used almost entirely as an intermediate in the manufacturer of other chemicals and is toxic to fish, aquatic invertebrates and affect plant growth. They can also be concentrated through food chains. The primary source of nonylphenols in the environment is its ethoxylates which break down into nonylphenol. The draft regulations are intended to reduce the risks from these compounds by prohibiting the marketing of substances and preparations containing concentrations of nonylphenol or nonylphenol ethoxylates equal to or greater than 0.1% by mass.
(DEFRA, 23 March 2004)
The UK Chemical Industries Association's surfactant manufacturers sector group has announced that it has implemented the voluntary agreement on reducing nonylphenol and its ethoxylates. Under the agreement, companies will take action to support risk reduction and inform their customers of marketing and use restrictions.
(Chemical Industries Association News Release, 7 January 2004)
Radioactive substances
Views are being invited by 20 April 2004 on proposals for the justification of practices to be implemented in Ionising Radiation Regulations 2004. The regulations, which are currently in draft form, will transpose two EU directives. These concern basic safety standards for the protection of the health of workers and the general public from ionising radiation (96/29/Euratom) and the health protection of individuals from ionising radiation in relation to medical exposure (97/43/Euratom). Justification involves assessing the benefits to people of exposure to ionising radiation against any likely harm and is required before new classes or types of practice can be approved. The new regulations will set a framework for future justification decisions, which will also be used to review practices when new evidence about their effects becomes known. They will lay down the process for making applications, who takes justification decisions, and requirements for consultation, notification and enforcement. The regulations also contain provisions to prohibit the addition of radioactive substances to ornaments and toys.
(DEFRA, January 2004)
REACH
DEFRA has launched a consultation on the proposed EU Regulation for controlling the manufacture and use of chemicals, the so-called REACH (Registration, Evaluation, Authorisation and Restrictions on Chemical) regime. Adopted in October 2003, the regime would also establish a European Chemicals Agency. The consultation document is aimed at gathering views from a wide range of stakeholders, including industry, environment groups and health and safety professionals, to feed into negotiations at EU level. It states that the Government's position is to ensure a fast and efficient process and it will lobby for 'one substance, one registration' to make the system cost effective. The Government also intends to ensure that the final regime will maintain industrial competitiveness and minimise animal testing. If implemented properly, it says that the regime will provide safeguards to human health and the environment, although it acknowledges the difficulties of quantifying these benefits. The consultation, which closes on 25 June 2004, estimates that the direct costs to the UK will be £515 million over eleven years.
(DEFRA, 30 March 2004)
In a consultation paper entitled 'Protecting People and the Environment from Hazardous Chemicals', DEFRA has set out proposals to revise the UK's chemicals strategy, published in 1999. The consultation document also seeks views on the implications of the EU's draft REACH Regulation for the UK, including the extent of resources that should be channelled to influencing further this Regulation at EU level. However, the document points out that this legislation will take a number of years to come into effect and in the meantime it says that it is vital that the UK chemical strategy is effective in preparing industry for the new legislation. Four options for improving the effectiveness of government action are set out in the paper. The government's preferred option is to continue with the current UK Chemicals Stakeholder Forum and to extend its remit to advise government on developments of REACH. This would mean that the Forum would carry out detailed examination of individual substances and encourage industry to co-operating in the examination of substances of concern. All responses must reach DEFRA by 4 May 2004.
(DEFRA, February 2004)
Plans to develop a database of the chemicals marketed in the UK have been unveiled by the Chemical Industries Association (CIA). The move is in response to the proposed REACH Directive currently being debated at EU level. The first phase of the work will involve gathering information on all the chemicals marketed in the UK by CIA member companies and will involve finalising the scope of information to be included. The CIA has said that the database is a step towards a sustainable development strategy. At present it has not been decided whether to include waste or all trade names in the database.
(CIA, January 2004)
Dioxins and PCBs
DEFRA is seeking comment by 16 April 2004 on two research reports concerning dioxins and PCBs. The two reports, one of which investigates the research priorities and the other costs for abatement of dioxin emissions to air, resulted from responses to a consultation paper issued in October 2002. DEFRA would now like to know whether the priority areas identified in the review and the current state of knowledge are appropriate to support the aim of reducing the exposure of people and the environment to emissions of dioxins.
With regards to the report examining the costs, it would like views on whether the approach taken is appropriate for identifying measures for reducing dioxin emissions.
(DEFRA, January 2004)
Decontamination
Guidance on the decontamination of the environment in the event of a chemical, biological, radiological or nuclear incident has been made available. It is intended for organisations involved in responding to such incidents. These are likely to include government departments, local authorities, businesses, emergency services and emergency planning communities. The guidance also reveals the government's intention to consider establishing a new service which would be available permanently for advice and assistance in the event of an incident. It has promised to release further details in the near future. The aim of the guidance, which would be subject to continuing review, is to provide basic recovery principles and an understanding of the key issues that might need to be addressed.
(DEFRA, March 2004)
Fertilisers
Proposals to revise or revoke the Fertilisers Regulations 1991 (SI 1991 No 2197) have been issued for consultation. These Regulations control the composition, labelling and packaging of fertilisers throughout Great Britain, and regulate a range of fertilisers used in agriculture, horticulture and for amenity purposes. The Regulations implement a series of EU Directives which have recently been consolidated into Regulation EC No 2003/2003 which is directly applicable in Member States from December 2003. The purpose of the current consultation is to develop domestic legislation to implement these EU Directives applying to EC-designated fertilisers. The options currently under consideration by DEFRA are: revoke the Regulations and have no controls on non-EC designated fertilisers; revoke the Regulations and require that all materials sold as fertilisers in Great Britain should be EC designated; revise the Regulations to incorporate an approval procedure for non-EC designated fertilisers; or revise the Regulations to take account of anomalies and emissions without incorporating an approval procedure. Comments are invited until 18 June 2004.
(DEFRA, March 2004)
GMOs
A consultation paper issued jointly by DEFRA and the Food Standards Agency (FSA) is seeking views on new traceability and labelling rules of GMOs and GM food and feed. The new regulations are necessary to implement two EU Regulations – (EC)1830/2003 on the traceability and labelling of GMOs and (EC) 1829/2003 on GM food and feed. The new regulations will lower from 1% to 0.9% the threshold above which the presence of intentional material from a GMO in a non-GMO product will trigger traceability and labelling of the product. Those products intended to include GM material must always be labelled, irrespective of the level present.
The new regulations will also implement requirements for extending controls on GM products by including constituents derived from a GM source which cannot be detected in the final product. The consultation package contains draft legislation with penalties for non-compliance, a draft regulatory impact assessment and draft guidance notes. The consultation ends on 25 June 2004.
(DEFRA/FSA, 30 March 2004)
The Advisory Committee on Releases to the Environment (ACRE) has published guidance on the best practice for post-market monitoring of GMOs. Under the Deliberate Release Directive (2001/18/EC), which provides an EU-wide regime for the commercial import and cultivation of GM crops, there is a requirement for such monitoring for any environmental harm if approval is granted. In the UK, the ACRE reviews all applications and advises the government on the potential risks to human health and the environment from any release. Its new guidance lays out the general principles to be adhered to for monitoring GM crops during marketing and in the post-market monitoring plan.
(ACRE, 31 March 2004)
A position statement issued by the British Medical Association (BMA) says that more research and continued surveillance is necessary to address public concerns over the potential risks to health and the environment posed by GMOs. Although it says that the available research points to there being very little potential for harm to health, it thinks the public still believed that further research was necessary.
(BMA Press Release, 9 March 2004)
The Secretary of State for the Environment, Food and Rural Affairs has issued a statement on the government's policy on GM crops. The main points of the policy statement are to: assess GM crops on a case by case basis, taking a precautionary and evidence based approach; provide the choice for consumers through labelling of GM food; and consulting on issues relating to the co-existence of GM and non-GM crops. She said that the policy had been finalised after evaluating evidence obtained from the GM public debate, the science review, the farm-scale evaluation trials and a report by the Agriculture and Environmental Biotechnology Commission on co-existence and liability issues. It also stated that the UK would oppose EU approval for the commercial cultivation of the GM wheat and oil seed rape tested in the farm scale evaluations and only allow the GM maize tested if it was accompanied by restrictions to limit herbicide use.
(DEFRA News Release, 9 March 2004)
Azo dyes
The Controls on Certain Azo Dyes and "Blue Colourant" Regulations 2003 (SI 2003 No 3310) prevented from January 2004 the placing on the market and use of certain products containing azo dyes. This provision implements an EU Directive on azo colourants (2002/61/EC) which amends the Directive restricting the marketing and use of dangerous substances and preparation (76/769/EEC). A further amending Directive (2003/3/EC) will also restrict the marketing and use from 30 June 2004 of "blue colourant". The Regulations set out exclusions such as azo dyes or blue colourant used for research and development purposes, their carriage by rail, road, inland waterway, sea or air and those exported to non-EU countries. Azo dyes are used mainly for colouring textiles and have been found to be toxic to fish and other aquatic organisms when released into water courses.
(SO, 17 December 2003)
Flame retardants
New Regulations banning the use of the brominated flame retardants penta and octa bromodiphenyl ether (penta BDE and octa BDE) will come into force on 15 August 2004. They implement an EU Directive (2003/11/EC) which amends the marketing and use of certain dangerous substances and preparations Directive (76/769/EC). Marketing of either of the substances, as a substance or as a constituent of substances or preparations, in concentrations higher than 0.1% by mass will be prohibited. There are certain exclusions from the scope of the Regulations such as use for research and development and export outside the EU.
(SO, 12 February 2004)
Chlorinated paraffins and arsenic compounds
Restrictions on the marketing and use of arsenic compounds and hexachloroethane have been introduced by the Environmental Protection (Controls on Dangerous Substances) Regulations 2003 (SI 2003 No 3274). They implement an EU Directive which amended for the 20th time Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and the preparations (2002/45/EEC). The Regulations also implement with regards to arsenic, a tenth adaptation to technical progress to Directive 76/769/EEC (2003/2/EC). Marketing of short chain chlorinated paraffins for use as substances, or as constituents of other substances or preparations in concentrations higher than 1%, either in metal working or leather processing was prohibited from 6 January 2004. The new restrictions introduced on the use of arsenic compounds as wood preservatives, which will come into force on 30 June 2004, apply to use of these compounds on a range of materials coming into contact with the aquatic environment. However, some industrial applications in the construction industry will have a derogation providing there is adequate fixation of the wood preservative. The Regulations also revoke the Environmental Protection (Controls on Hexachloroethane) Regulations 2003 (SI 2003 No 602) and re-enact the ban on this substance in the manufacture and processing of non-ferrous metals.
(SO, 13 December 2003)
European Union
Mercury
Views are sought by the European Commission on policy options for dealing with mercury. It is part of the Commission's plans to develop a strategy on the use, control, and impacts of mercury and mercury-containing compounds. The consultation paper outlines the problems associated with mercury, including high levels in the environment which in some circumstances exceed levels deemed safe for health. Mercury-containing compounds can also accumulate through food chains and the metal is capable of being transported over long distances as it is often emitted as a gas. Among the policy measures proposed to address the problem are: introducing controls on emissions to air in the Large Combustion Plants Directive (2001/80/EC); incentive based mechanisms such as penalties for emissions and possible trading of emissions; EU-wide emission limits for crematoria; re-use of waste mercury in preference to new production; and a gradual global phase out of mercury use. Comments on the strategy should reach the Commission by 11 May 2004, with the Commission due to publish its mercury strategy in September 2004.
(European Commission, 15 March 2004)
Radioactive substances
Measures designed to enhance controls and prevent accidents involving radioactive sources have come into force after publication of a Directive in the Official Journal. The control of high-activity sealed radioactive sources and orphan sources (2003/122/Euratom) is especially aimed at protecting the population and workers from accidental exposure to ionising radiation from sources no longer in use. It sets out the specific requirements on traceability of radioactive sources throughout the lifetime of equipment containing the source and also at the end of life stage. In practice, this will mean providing for detection systems for orphan sources and organising campaigns for recovery. It will also ensure that responsibilities and intervention procedures are laid down for all sources, including those used in industry, medicine and research. There will be obligations at all levels involving prior authorisation for the use of any high activity radioactive sealed source. This will also require proof of safety management and financial provision. Sources will have to be identified and marked and the identity of the person using the source and the place of use documented.
(OJL 346, 31 December 2003)
Phthalates
The Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) has published two reports relating to the use and safety of phthalates used as plasticisers in soft PVC. In Western Europe it is estimated that over 90% of plasticisers used in PVC are phthalates. The first report deals with the safety of acetyl tributyl citrate (ATVC) which is one of the main alternatives to phthalates in soft PVC. CSTEE found that ATVC posed no safety problems for children mouthing PVC toys. In a second report the CSTEE concluded that the phthalate DEHP poses no risk to adults through environmental exposure. However, it called for more studies before it could be declared that there is no risk to babies through contamination of breast milk. DEHP is used in a number of applications such as healthcare products, including blood bags, and floor coverings.
(CSTEE, 8 January 2004)
PAHs
A proposal for a directive on restrictions for the marketing and use of polycyclic aromatic hydrocarbons (PAHs) in extender oils and tyres has been published by the European Commission. It will amend the Marketing and Use Directive (76/769/EEC) to restrict the placing on the market and use of extender oils and tyres containing certain PAHs above certain thresholds across the EU. Under the proposals, extender oils may not be placed on the market and used for the production of tyres if they contain more than 1mg/kg benzo(a)pyrene (BaP), or more than 10 mg/kg of the sum of all listed PAHs. The objective of the legislation is to reduce the emissions of tyre debris containing carcinogenic compounds into the environment. The extender oil is incorporated into the rubber matrix of the tyre where it remains but ends up in tyre debris.
(COM (2004) 98, 13 February 2004)
COMAH
Directive 96/82/EC on the Control of Major-Accident Hazards involving Dangerous Substances has been amended by a Directive (2003/105/EC) published in the Official Journal. The amendment extends the scope of the 1996 Directive to include certain storage and processing activities in mining, pyrotechnic and explosive manufacturing sites, as well as sites of storage of ammonium nitrate and similar fertilisers. The amending Directive was first proposed in 2001. Member States must implement it by 1 July 2005.
(OJL 345, 31 December 2003)
International
POPs
The United Nations Environment Programme (UNEP) announced that the Stockholm Convention on Persistent Organic Pollutants (POPs) will enter into force on 17 May 2004, after France became the 50th state to ratify in February. The next meeting of Parties to the Convention is due to take place in early 2005. At this meeting it is hoped to address the substitution of DDT with safe alternatives for combating malaria. Although most of the 12 chemicals will banned immediately, the use of DDT will continue for malaria control due to a lack of suitable alternatives. The meeting will also establish a committee for evaluating other chemicals and pesticides that could be added to the initial list of 12. It will also seek to finalise guidance to try to reduce to a minimum releases of dioxins and furans which are among the most toxic POPs.
(UNEP Press Release, 18 February 2004)
For Further information please contact Mark Rutter at mark.rutter@cms-cmck.com.
