Parliament backs safety assessment of chemicals[de] 

MEPs have approved by a large majority (407 votes in favour, 155 against and 41 abstentions), the highly controversial REACH proposal to evaluate and possibly ban chemical products based on human health and environmental safety grounds.

The Parliament plenary sealed a political agreement struck a week before between the three main political formations, the centre-right EPP-ED, the socialists (PES) and the liberals (ALDE) (for more, see EurActiv, 8 Nov. 2005).

If backed by EU ministers later this year, it would mean that some 30,000 potentially hazardous chemicals, which have sometimes been in use for decades, will need to go through at least basic assessment before receiving authorisation. Otherwise, they could face a ban.

Substitution

However, the chances of an early agreement with EU ministers seemed to drift away when MEPs gave their backing to the so-called 'substitution principle', which requires companies to drop dangerous chemicals and replace them with safer alternatives when these are available. This provision has been fought hard by industry and has so far proved too controversial to be included in any compromise agreement in Council.

Another provision on which compromise could not previously be found concerns time-limits on authorisations, which the agency could grant for a limited period of five years.

Registration

Under the text voted on  by Parliament, registration for chemicals produced or imported in smaller quantities (1 to 10 tonnes per year) is made simpler in order to meet one of the key demands of large industrial producers. Registration for existing substances (those in circulation before 1981) in this low tonnage range will be targeted at chemicals of high concern only and the safety data reduced to the basics. 

MEPs however maintained the cornerstone principle of REACH which places the responsibility on companies to prove their products are safe before they are allowed onto European markets ('burden of proof'). 

In supporting the cross-party compromise, MEPs also confirmed the option for companies to do away with safety tests on chemicals produced or imported in larger quantities (10 to 100 tonnes a year). Waivers would be granted by the agency based on satisfactory justification of risk by the companies. The criteria for granting waivers will be defined at a later stage by the Commission within 18 months after the regulation is in force using a fast-track 'comitology' procedure.

Finally, mandatory data sharing under the One Substance, One Registration (OSOR) proposal is made more flexible with an opt-out option allowing companies to register on their own. This caters for one crucial demand from industry which called for confidentiality to be safeguarded. The agency will assess opt-outs against three criteria.

The Commission welcomed the vote in Parliament. "By supporting the Sacconi/Nassauer compromise on registration the EP strikes a very good balance between the health, environment and competitiveness goals of REACH," the Commissioners Verheugen (enterprise) and Dimas (environment) said in a statement. 

The Centre-right EPP-ED group in Parliament approved the vote on "core issues" relating to registration. However, it rejected new provisions concerning substitution as "an anomaly". "Parliament voted for the introduction of a complex system of renewal of the authorisation every five years in which chemical products must undergo the whole procedure again and again". Pointing out that the Council will likely reject this provision, EPP-ED spokesperson Oomen-Ruijten MEP said she was looking forward to a second reading to "remove this anomaly from the text".

The socialist group (PES), led by REACH Rapporteur Guido Sacconi MEP, said the Parliament voted "to give people in Europe the strongest protection in the world from dangerous chemicals". Guido Saccconi declared: "The most dangerous chemicals will be authorised only under strict conditions. Authorisations will be time-limited in order to encourage innovation and the development of safer alternatives." These provisions, he added, will not threaten the competitiveness of European firms with bureaucratic procedures. Sacconi said he managed to secure a political agreement "despite intensive lobbying by industry opponents" and "a hard-line campaign of misinformation" which brought "unbelievable pressure" on MEPs.

The Greens denounced the Parliament's position as "a false promise that is unlikely to deliver" on human health and environment protection against hazardous chemicals. According to the Greens, the compromise on registration will mean a "drastic reduction" in key tests for the 20,000 chemicals produced in low tonnage (1-10 tonnes a year). Risk-based registration, the Greens said, perpetuates "the very ignorance [REACH] seeks to end". "To know the risk, you first have to test," Carl Schlyter MEP pointed out. On the positive side, the Greens welcomed the "paradigm shift" on the most dangerous chemicals. "When safer alternatives are available, the troublemakers simply have to go".

The European Chemical Industry Council  (CEFIC) welcomed the vote in Strasbourg as "an important step in the process", especially on the registration aspects of REACH. However, it expressed disappointment concerning possible time-limitations on authorisation. CEFIC said it hoped these could be redressed at a later stage by the Council or the Commission.

UEAPME, the European organisation for small and medium business, is clearly worried. "Data-sharing opt-outs could be carte blanche for large industry monopolisation," UEAPME warned. "The broad exemptions from the One Substance One Registration (OSOR) principle will compound the disadvantages faced by small businesses under REACH and represent a triumph for big chemical manufacturers," said UEAPME Secretary General Hans-Werner Müller. "The added layers of bureaucracy in the authorisation phase are a slap in the face to small firms and undo some of the progress on registration," he added.

The European association of engineering industries, Orgalime, which are big downstream users of chemicals, expressed satisfaction over the registration aspects of the Parliament's vote. "With the EP's decision to base information in the supply chain on use and exposure categories, rather than on the basis of single uses only, MEPs have paved the way to properly address what is a key issue for downstream users", said Orgalime Secretary General Adrian Harris. However, Harris criticised the MEPs vote on authorisation. "our industry needs a risk based authorisation process that ensures sufficient time for finding alternative solutions if a substance will no longer be available", said Harris. With the current compromise, he said the process would be "by far too inflexible".

The WWF, together with other environmental, health and consumer organisations, recognised the "important sep" represented by the Parliament approval of REACH for the health and safety of citizens and the environment. The organisations particularly welcome that MEPs backed an obligation to replace hazardous chemicals with safer alternatives when these are available, the so-called 'substitution principle'. However, they warned that concessions made on testing requirements "for all chemicals covered by REACH" means thousands will escape crucial health and safety assessments. "A REACH adopted on this basis will not deliver the health and environment protection the public needs, as it would leave thousands of chemicals without basic toxicity data," the group said. 

The European consumers' organisation (BEUC) said it is "deeply disappointed" by the Parliament's decision to back the Sacconi-Nassauer compromise on registration. "Today's vote won't allow a proper in-depth assessment of the most problematic substances consumers are faced with in their daily lives," BEUC said in a statement. BEUC Director Jim Murray said a "weak" REACH today will mean a new "REACH 2" in some years' time when the shortcomings of the original proposal become obvious - and when the dangers of some substances have sadly become obvious after the damage is done".