On 1 December, Italian socialist MEP Guido Sacconi unveiled the details of a compromise deal struck the night before between the EU's three lawmaking bodies - Parliament, Council and Commission - on one of the EU's most disputed pieces of legislation.
The Parliament's three largest political groups, the centre-right EPP-ED, the socialists and the liberal democrats (ALDE) have already signalled their readiness to support the package, agreed after marathon talks on Thursday (30 November).
The compromise will now be put to a vote by Parliament on 13 December and then forwarded to the EU Council of Ministers for a formal rubber-stamping exercise.
As Parliament's chief negotiator on REACH, Sacconi admitted that he had to scale down his level of ambition following concerns by Germany and industry groups that the regulation would be too costly for the chemical sector. "Everyone should understand that it would be impossible to reach a better compromise," Sacconi said.
Central to the agreement is the conditions under which the most toxic substances are to be substituted for safer alternatives:
- Persistent and bioaccumulative chemicals (PBTs, vPvBs) are to be replaced whenever safer alternatives are available at an economic cost;
- but conditions are less stringent for carcinogens and mutagenic chemicals (CMRs), which will be authorised when producers can show that the risk they pose can be "adequately controlled". This means that scientists can agree on a "safe threshold" under which their presence in the human body is not considered to pose a health risk:
- if a safer alternative exists, they will need to submit a substitution plan so that they are eventually replaced;
- if a safer alternative is not readily available, companies will need to produce an R&D plan for substitution at a later stage. However, substances toxic to reproduction (endocrine disrupters) are exempted from the clause. A review will take place six years after the regulation comes into force to take account of new scientific developments on the subject;
- deadlines for substitution are to be decided on a case-by-case basis, for each substance, and;
- the registration process has been extended from three to 3.5 years to give industry more time to comply.
Substances produced or imported in smaller quantities (1-10 tonnes per year) were exempted from full health and safety tests in order to bring down costs for industry. Their number is estimated at around 17,000. Here too, a review clause seven years after adoption will decide whether to tighten controls.
Efforts were also made to preserve confidentiality of sensitive business information as data is circulated along the supply chain with data protection rights extended from three to six years. Companies will be allowed to keep details confidential such as the full composition of a preparation, its precise use, tonnage and links with downstream users.
Although he gave ground on authorisation aspects, Sacconi obtained satisfaction on aspects concerning the future chemicals agency to be established in Helsinki:
- Two members will be appointed by Parliament, and;
- the agency's executive director will need to be confirmed after an audition in Parliament where he will outline his programme.