Les ministres européens adoptent des règles souples au sujet des substances dangereuses[en] 

The UK Presidency convened an extraordinary meeting of the Competitiveness Council on 13 December to try and find a common position on the proposed REACH regulation (Registration, Evaluation and Authorisation of Chemicals).

EU ministers had previously agreed on the aspects of REACH dealing with producers' obligation to register health and safety data about the chemicals they wish to (continue to) commercialise (EurActiv, 1 Dec. 2005). The compromise closely matched the line adopted by the Parliament when it voted on REACH in first reading last November (EurActiv, 18 Nov. 2005).

According to the Commission, safety information is "sketchy for around 99%" of the 100,000 chemicals that were introduced before 1981. REACH proposes to assess about 30,000 of them since it leaves out substances produced or imported in quantities of less than one tonne per year. Under the current compromise on registration, it is estimated that about 12,000 will escape full safety data submission, mainly for substances produced or imported in small quantities (1-10 tonnes a year). The exemptions are said to concern only chemicals which do not raise particular concerns for human health and the environment.

Ministers struck an agreement on the draft REACH regulation on 13 December, finding a compromise on how to authorise the most dangerous substances or replace them with safer alternatives. The vote paves the way for a second reading in Parliament and Council next year and a final agreement before the end of 2006.

However, more drama is expected at second reading in Parliament with the Greens group heavily criticising the agreement and the majority centre-right EPP-ED group calling for further concessions to industry. 

Authorisation of most dangerous chemicals

The key remaining point EU ministers had to deal with concerned approval rules for those substances that cause cancer, genetic mutations or reproduction problems, as well as those that accumulate in human bodies and the environment. 

Under the Council compromise, the future chemicals agency in Helsinki will grant authorisation for these dangerous chemicals only after companies can show that: 

• "the risks are adequately controlled" 
• "social and economic benefits outweigh the risks" or
• analysis has shown "suitable alternative substances do not exist" 

In a statement , the UK Presidency said "authorisations should not be granted on the grounds of adequate control in the case of substances that are persistent, bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative (vPvB)".

Precisely under which circumstances can toxic substances be considered to be "adequately controlled" will be defined by the Commission with help from member state experts, using a fast-track procedure ('comitology'). This will be decided within 12 months of REACH coming into force. According to the UK Presidency, the definition will only concern "substances where it is not possible to determine safe thresholds with current methods".

Once adopted, the definition will be inserted in Annex I of REACH which deals with general provisions on how to assess substances. The amendment has been added at the request of Commissioner Verheugen, according to French Industry Minister François Loos, who said the amendment extends the procedure to the revision of all other REACH annexes.

Exemptions and time limitations to authorisation rules

A number of exemptions have been granted, notably to chemicals used for R&D purposes, which are broadly unaffected by REACH. In what is perceived as a gesture to small businesses, SMEs can be exempted from registration tax if they show "a complete registration form".

Ministers also agreed that the length of time limitations to authorisations granted for the most dangerous substances - those which cannot be replaced under the above conditions - should be decided on a case by case basis. In plenary, Parliament had adopted a one-size-fits-all review for all products of major concern every five years.

Data sharing (OSOR), 'duty of care' and 'right to know'

Ministers have limited the opt-outs to rules obliging companies to share information when submitting group applications under the One Substance, One Registration rule (OSOR). But they dropped the 'duty of care' and 'right to know' principles which would have strengthened companies' responsibility to handle chemicals safely and allowed information to be communicated to consumers.

Enterprise Commissioner Günter Verheugen was pleased with the vote, saying "we succeeded in maintaining the competitiveness of EU industry," including SMEs. According to the Commission, the use-specific authorisations agreed for the most dangerous chemicals "will encourage substitution of unsafe substances by safer ones". 

CEFIC, the European Chemical Industry Council, welcomed the fact that substitution will not be introduced as a mandatory procedure. It also welcomed the Council's decision to review authorisations for dangerous substances on a case-by-case basis rather than the time-limited authorisation that Parliament had voted for.  

European SME organisation UEAPME said that the Council position makes chemical rules "less damaging for small businesses". "The possibilities to opt-out from the One Substance One Registration (OSOR) seem to be more limited than those proposed by the European Parliament's proposals, which is an improvement for small formulators," UEAPME said. However, UEAPME continues to call for more extensive data sharing under OSOR. "Ultimately, providing for the compulsory sharing of all testing data will be the most effective way to avoid the duplication of testing and counteract the disproportionate cost burden", it said.

"It seems that we will need a REACH 2," declared BEUC, the European consumer organisation, who said the Council further watered down a draft bill that had already been weakened by Parliament. "The Council succeeded in making things even worse than the European Parliament by weakening the registration of chemicals, the substitution principle and foreseeing even less information available for consumers," said BEUC Director Jim Murray. Consumers, Murray underlined, need a strong REACH. "We will relentlessly continue to raise politicians' awareness as they must now take their responsibility to protect the health of future generations," Murray added. 

A coalition of eight environmental, women's, health and consumer NGOs expressed their "disappointment" at the outcome of the Council's vote. The group, which includes the likes of WWF and Greenpeace, said member states rejected calls to substitute hazardous chemicals with safer alternatives whenever possible. "Although chemical producers would be required to 'assess' substitutes for a hazardous chemical, decision-makers will still have to grant an authorisation under an 'adequate control' procedure, even if safer alternatives are available," the NGOs said. The Council's strengthening of the substitution principle for persistent and bioaccumulative chemicals "represent only a fraction of all hazardous chemicals," it added. The coalition concluded that "it is essential that the Parliament reaffirms its support for 'mandatory substitution' at the Second Reading, next year".

In her blog, Commission Vice-President and former environment chief Margot Wallström expressed disappointment with the new emerging text on REACH. "I cannot hide the feeling that the proposal could have been more far-reaching and that I would have wanted to see a more ambitious chemicals management regulation," she writes.

Wallström admits that REACH "will not be free". But she adds that "the alternative (paying for damage to health and environment)", would be "even more costly".  "If REACH succeeds in reducing chemicals-related disease by only 10%, which is a conservative estimate, the health benefits will amount to more than €50 billion over 30 years," she writes.