Regulatory compliance for chemical, cosmetic and biocidal products.
REACH
REACH background
The European Commission's REACH proposal heralds the biggest shake up in chemicals legislation since the inception of the Dangerous Substances Directive (DSD) (67/548/EEC). While the DSD shied away from tackling the safety assessment of chemicals in commerce before September 1981 (existing chemicals; ca. 100 000 listed on EINECS), concentrating only on the far fewer chemicals marketed after this date (new chemicals; ca. 3800 listed on ELINCS), REACH (Registration, Evaluation and Authorisation of Chemicals) meets this challenge head on, sweeping away the current twin-track scheme and introducing a single, tonnage-tiered, evaluation system for all commercial chemicals.
The need for an overhaul EU chemicals legislation is demonstrated by the lack of publicly available information on existing chemicals. A 2003 Commission report showed that of 2465 high production-volume chemicals (produced or imported into the EU at > 1000 t/y), only 14% o had the equivalent of the base-set of tests (required at >1 t/y for new chemicals), and a shocking 21% had no data at all.
Also, the burden of risk assessment of chemical products has rested with the authorities. The lack of hazard data, coupled with a paucity of data on the handling and use of chemicals, has led to painfully slow progress on the assessment and control of chemicals. Since 1993, ca. 150 high-volume chemicals have been identified for risk assessment, of which ca. 30 have completed the evaluation process under 793/93. Since 1976, restriction on marketing and use (according to 76/769) has been applied to only ca. 100 substances, along with ca. 900 substances classified as carcinogenic, mutagenic or toxic to reproduction.
REACH will require the registration of ca. 30 000 substances. Of these, some 20 000 are marketed at 1 to 10 tpa, and will require in vitro testing only (full testing costs estimated at €31 000), and a further 10 000 are marketed at over 10 tpa, and will attract roughly the base-set of tests (full testing costs estimated at ca. €80 000 per substance). Many of the rest of the existing substances in EINECS are site-limited intermediates that are not ‘placed on the market’. The total estimated of direct costs for the scheme are estimated at €2.8 to 5.2 billion over the first eleven year evaluation period, with ca. 90% of the costs of testing and registration will be borne by manufacturers/importers.
Environment Commissioner, Margot Wallström has justified the costs as proportionate and reasonable: ‘There are potentially 100 000 chemicals produced and used in the EU...for a very limited number of these do we have adequate information about the risks they pose to human health and the environment.’ She continued, ‘In the United Kingdom alone between 1500 to 3000 new cases of chemical related occupational asthma are reported every year. Over 10 years, the total cost to British Society is estimated at €0.8 to 1.6 billion. Even a small reduction in the incidence of allergies in the European Union will offset the cost of our new chemicals strategy.’ Other concerns put forward by the Commission, were from chemicals that bioaccumulate or interfere with the endocrine system.
In effect, industry is caught in a Catch 22, because their complaints about the cost of testing for assessment of existing chemicals brings accusations of not having adequately demonstrated the safety of their products in the first place, relying instead on less convincing ‘experience in use.’
Since the publication of the proposed REACH Regulation, many SME chemical companies have voiced some concerns that the new scheme could spell economic disaster. A report Assessment of the Business Impact of New Regulations in the Chemicals Sector validates some of these concern, concluding that for SME chemical manufacturers, the testing and registration costs may have a potentially serious effects on their financial viability. The Commission have consequently reduced the costs of registration for SMEs, but this reduction may be offset by an increase resulting from the spiralling cost of the new European Chemicals Agency (ECHA), which will oversee the REACH processes.
The picture for SME manufacturers and importers is not all gloom. The rise in tonnage threshold for the registration of substances from the current 10 kg/y for new chemicals to 1 tonne/annum under REACH will particularly benefit SME companies. SMEs are currently more likely than larger producers to notify their substances at less than 1 tonne per annum (51% vs 16%). SMEs will therefore also benefit from the exemption from in vivo toxicity testing of phase-in substances manufactured/imported at 1 to 10 t/y.
The European Commission also points out that the current requirements inhibit innovation, as new substances require testing while existing ones do not. Indeed, Commissioner for Enterprise, Erikki Liikanen said, ‘weaknesses in Europe’s innovative performance and a slower introduction of new technologies are at the origin of the gap with the US.’ Ms Wallström stated, ‘the new chemicals system will undoubtedly encourage the replacement of potentially hazardous substances by safer alternatives. This will stimulate innovation… It should mean more jobs and not less jobs.’
Other advantages of the new scheme are that testing for higher tonnage substances is tailored to the risk, and the time for product and process oriented research and development (PPORD) (ie exemption from registration for pre-commercial substances) is to be extended from one to five years. There may be further ways of reducing the costs associated with testing of lower volume substances, for example by finding effective ways of grouping chemicals and applying read-across methods for risk assessment purposes. It is clear there will be winners and losers depending on market position.
Because of cost implications, manufacturers may cease production of low volume, low value substances and focus on their main consumer sectors. This may mean that downstream users will lose some of the supply chemicals they rely on, and may be left with substantial re-formulation costs. Downstream users are also concerned that the loss of substances will damage their flexibility to innovate, and that the public availability of information on composition will provide competitors with the opportunity to copy their products or enter into their market segment. Confidentiality is a complicated and hotly debated topic in all new chemicals legislation..
The Commission hopes to improve confidence in the chemicals industry, and be better placed to protect the public and the environment from the potential harmful effects of chemicals. However, the REACH legislation is also part of a larger agenda. Mr Liikanen stated ‘the overriding political objective guiding the Commission’s strategy for a new Chemicals Policy is sustainable development, …this means…the right balance between environmental, economic, and social priorities.’ The driving force in chemicals policy may go beyond the EU Commission to the United Nations and the World Summits on Sustainable Development. Globalisation will be the key to future development in chemical policy.
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