Chemicals Policy review (REACH)[fr][de] 

• Basic socio-economic facts

The chemicals industry is the third largest manufacturing industry in the EU, generating 1.7 million jobs and indirect employment for more than 3 million people. In total, the EU produces 31% of the world's chemicals (US, 28%)

• What's the problem with chemicals?  

There is a general lack of knowledge regarding the 99% of chemicals (around 100,000 'existing substances') that were placed on the market before 1981. This is because prior to that date, no stringent health and safety tests were needed to market chemicals. There are 3,000 so-called 'new substances' which had to go through a more stringent safety screening after 1981.

While some well-known chemicals, such as asbestos, are already banned, the Commission believes that the rising incidence of diseases such as cancer and leukaemia could be linked to chemicals. Blood tests in humans and animals have shown contamination by known toxic substances, raising questions as to how they enter the body and the extent of the damage that they could cause (see also LinksDossier on Biomonitoring).

Under the system, both "existing" and "new" chemicals will be screened for health and safety over an 11-year period.

Central to the system is a requirement for producers and importers of chemicals to prove that their substances are safe before they can be placed on the market. Under the previous system, it was up to the authorities to prove that a substance posed a threat before it could be withdrawn (reversal of burden of proof).

A new chemicals agency in Helsinki will be tasked with authorising or rejecting the applications. Failure to register will mean a substance cannot be manufactured or imported into the EU.

Registration

Safety screening and registration will take place in three stages, based on two broad sets of criteria: 

• Volumes produced or imported per year: 
  • >1000 tonnes within 3 years;
  • 100 - 1000 tonnes within 6 years;
  • 1 - 100 tonnes: within 11 years, and; 
• risk: highly hazardous substances will be assessed in priority within the first three years. These are CMRs (carcinogenic, mutagenic or toxic to reproduction), PBTs (persistent, bio-accumulative and toxic), vPvBs (very persistent and very bio-accumulative) and other substances "of equivalent concern"

In a last-minute compromise, the first phase of the registration process was extended from three to 3.5 years to give industry more time to comply.

In addition, the following rules were agreed in order to make the registration process as little bureaucratic as possible:

• Group applications: 'one substance, one registration' (OSOR) principle requires companies to submit safety data jointly in a consortia when registering similar substances with the agency. Opt-outs from this mandatory principle can be granted to companies who can prove disclosure would harm their commercial interests or violate their intellectual property rights. 
• 1-10 tonne range: 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. The exemptions are said to concern only chemicals which do not raise particular concerns for human health and the environment.
• 10-100 tonne range: companies can ask to opt-out from safety tests ('waiver'  option) provided they can prove that the health risks posed by the substance are "adequately controlled". 

  
Authorisation

The conditions under which the most toxic substances are to be substituted for safer alternatives proved the most controversial in the negotiations between Council and Parliament. The final compromise states that:

• PBTs and vPvBs are to be replaced whenever safer alternatives are available at an acceptable socio-economic cost. This means that the health and environmental benefits of withdrawing the substance outweigh those of keeping it on the market (for example in terms jobs or if they cannot be readily replaced);
• conditions are less stringent for carcinogens and mutagenic chemicals (CMRs), which will be authorised if 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;
• exemptions can also be granted for chemicals used for R&D purposes

Efforts were also made to preserve confidentiality of sensitive business information as safety 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 industrial users of a given substance. 

Agency

Although the Parliament gave ground on authorisation aspects, it 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. 

Other aspects

• Scope of the system
  • Polymers were exempted from registration;
  • the requirements for registering a substance within finished  products ('substances in articles') were softened.
• the "duty of care" provision for industry has been more clearly defined as companies feared they would be confronted with open-ended liability claims;
• to try and limit costs, the obligation for downstream industrial users of chemicals to produce safety assessments and reports was strictly limited.
  

On the economic impact of the proposed legislation, the Commission, industry and NGOs have all come up with very different estimates. The Commission estimated the overall economic impact at around 2.3 billion euro over 11 years (0.05 per cent of the annual turnover of the sector), but these figures were heavily disputed by industry studies performed by the German BDI and the Mercer study in France. NGOs, on the other hand, compared the costs to industry with the financial gains from reductions in public health costs and less negative impacts on the environment.

As regards the final agreement, reactions were mixed.

European Chemicals Industry Council (CEFIC) Director-General Alain Perroy said that he regretted the "unnecessary requirements added to the authorisation element of REACH" relating to the substitution of dangerous substances.

"It will clearly add to costs," said Perroy who denounced the "illusion" that substitution could be governed by a "command and control approach". The end result will be "legal uncertainty" for business and, consequently, reduced investments and innovation, Perroy warned.

European engineering association Orgalime, REACH will force changes to the whole supply chain of companies which frequently use many chemicals in consumer goods such as mobile phones. "It is not always easy to find an equally performing and reliable new supplier," said Orgalime Secretary-General Adrian Harris.

Guy Thiran of Eurometaux warned that key raw materials used in the metal industry would likely become costlier under REACH. He pointed out that naturally derived substances such as ores and concentrates do not fit in the categories defined under the draft. "Metals are elements, not conventional man-made substances," Thiran pointed out. "Alloys do not behave in practice as simple preparations."

Not all of the comments were negative, however, with UNICE, CEFIC, Eurometaux and Orgalime adding that some aspects of REACH had "moved in the right direction".
"Companies will not have to elaborate a Chemical Safety Report for substances [produced or imported] below ten tonnes a year. This is good news, particularly for SMEs," they said.

"Another example relates to 'data protection' where companies may now request confidentiality for the name of their substance in order to protect their information from unfair competitors."

Small-business organisations said that they appreciated efforts made to ease the bureaucratic burden for SMEs by cutting down on safety assessments for substances produced in smaller quantities. But overall, small business organisation UEAPME said the result is "quite disappointing."

The European trade union confederation (ETUC) welcomed the fact that the burden of proof is now firmly placed on producers to prove that their products are safe. "That marks clear progress, because industry will now have to provide information on the safety of their chemicals before they can put them on the market," said Joel Decaillon of ETUC.

Environmental organisations were doubtful about the compromise. On the positive side, Greenpeace and the WWF welcomed:

• The fact that companies will now be responsible to prove the safety of chemicals produced or imported in large volumes (above 10 tonnes a year);
• that there is a mechanism to replace persistent and bioaccumulative chemicals if safer alternatives exist, and;
• that the public is allowed to request information about the presence of chemicals in products. 
   

But on the negative side, they pointed to "major loopholes". These include:

• Less stringent safety requirements for carcinogens and chemicals which can cause birth defects and reproductive illnesses;
• substances imported in low volumes (below ten tonnes per year) for which "no meaningful safety data" will be required, and;
• provisions relative to 'high-concern' chemicals that will still be allowed onto the market if producers can prove that they can be "adequately controlled" when a "safe threshold" can be defined where their detection is considered as posing no threat to human health.