Regulation - The European Commission's review of REACh has concluded that there is no need for any major changes in the legislation -at least for the moment. This has been welcomed by much of the chemical industry which had been telling the Commission that it wanted the legislation to remain intact so companies can adhere to it without fear of any big alterations.

"The REACh review brings legal certainty for the foreseeable future," says Gerd Romanowski, director of Science, Technical and Environmental Affairs at the German Chemical Industry Association (VCI). "Now chemical companies can continue to fully focus on REACh implementation." Hubert Mandery, director general of the European Chemical Industry Council, said that since REACh is functioning effectively "there is no need for a revision."

However, other groups are not so happy with the review. Although the Commission promised measures to ease the cost burden of REACh compliance for small and medium sized companies, SME representatives think that it did not go far enough. NGOs also attacked the Commission for being too cautious so that what they believe are significant weaknesses in REACh are not being tackled.

Critics: Commission Avoids Confrontation

Critics of the review claim that the Commission opted for maintaining the status quo because it did not want to risk a possible confrontation with European Union governments and particularly the European Parliament when trying to push through amendments to the legislation. These would have had to be approved by the Council of Ministers, representing the EU's 27 member states, and the Parliament which would have been likely to take the opportunity to put down amendments of its own.

"Commission officials have been saying for some time that they wanted to avoid making any changes to the legal text, even though there were problems with it which needed to be sorted out," says Vito Buonsante, toxics lawyer at ClientEarth, Brussels, a campaigning group of environmental lawyers. "If changes to REACh had to be debated in the European Parliament, there would have been pressures from a variety of political groups for a wide range of changes, which would have caused a lot of political uncertainties."

The legislation on REACh (which stands for the registration, evaluation and authorisation of chemicals) stipulates that it must be reviewed by the Commission five years after it came into force in June 2007.

The Commission was obliged to look at a number of aspects of the legislation, the most important of which were "the experience acquired with its operation" and the effectiveness of the European Chemicals Agency (ECHA)-the Helsinki-based agency responsible for administering REACh.

The review comes at a time when only one of three phases of the registration with safety dossiers of at least 30,000 substances had been completed. This was for chemicals which are produced or imported by registrants in annual quantities of 1,000 tonnes or more and which had to be registered by late 2010. Substances produced or imported in amounts of 100 tonnes or more have to be registered by June 1 this year. The deadline for the remainder of 1 tonne or more is in 2018.

Commission: REACh Delivers

The Commission acknowledged that it is too early to be certain of the benefits or disadvantages of REACh to the EU's competiveness, level of innovation and above all public health which had been assumed to start to become evident only 10 years after REACh came into operation.

Nonetheless it decided that "REACh functions well and delivers on all objectives that at present can be assessed". Although the need for "adjustments" had been found, it had concluded that after taking into account the requirement for "legislative stability and predictability" changes to the "enacting terms" of the legislation were not necessary.

The Commission considered that in its role as administrator of REACh, the European Chemicals Agency had been effective with most stakeholders noting that it had performed well. But it thought the agency could have done a better job in disseminating data and in communication and transparency of information in general.

Striking the Right Balance

It rebutted accusations that ECHA had been favouring industry over other stakeholders. The agency had to focus a lot on companies because their compliance and commitment was essential to the success of REACh. The Commission was confident that ECHA would continue to strike the "right balance between independence and stakeholder engagement".

Among the Commission's other findings were that the quality of information available for making risk assessments on substances had improved compared with the pre-REACh era. More information being passed down the supply chain from REACh dossiers was also resulting in more appropriate risk management measures being taken at the point of use of chemicals.

The placing of substances of very high concern (SVHC) on the candidate list for their authorisation had increased development work on their substitution, according to the Commission. It claimed that these findings showed that progress was being made towards meeting the human health and environmental aims of REACh. However, it conceded that as reported by ECHA, many registration dossiers had not met the data requirements of REACh with some even failing to identify properly the substances that were being registered.

Some registrants were not assessing adequately the levels of persistency, bioaccumulation and toxicity of substances. There were also problems with the content and format of extended safety data sheets (eSDSs) for disseminating information in registration dossiers downstream. These enlarged SDSs were often too long and not easily understandable to workers handling the chemicals.

The Commission wants industry to take steps to improve the quality of registration dossiers and both ECHA and EU member states to do more to encourage compliance with data requirements. "Industry needs to take full ownership of its registration dossiers and proactively work on their quality, even after submission to ECHA," it says.

Financial Impacts of REACh on SMEs

One matter which the Commission wants to tackle relatively quickly is the financial impacts of REACh on SMEs. A recent survey of SMEs showed that they considered REACh to be among the ten most burdensome pieces of EU legislation.

ECHA has already been looking at ways to lower registration fees for SMEs. But the major concern of SMEs is the cost of collecting safety, either jointly through Substance Information Exchange Forums (SIEFs) or by drawing up their own dossiers.

A major difficulty for small companies is the fees charged within SIEFs usually by bigger producers with R&D operations for sharing data through the provision of 'letters of access'. SMEs have also been complaining about their disproportionate share of SIEF administrative costs.

The Commission has asked ECHA and industry to "address concerns" on cost sharing while calling for stronger incentives to "ensure an economically efficient SIEF administration".

"The big burden for SMEs is not the level of registration fees but the cost of gaining access to data," says Peter Newport, director of the UK Chemical Business Association (CBA), representing SMEs in chemicals production and distribution. "The Commission has recognized the issue but is just making pious observations about the need for fair cost sharing. We have examples of members who may have to go out of business because of the high fees for letters of access."

The European Association of Craft, Small and Medium-sized Enterprises (UEAPME), the main pan-European organisation representing SMEs, wants fees for letters of access to be linked to the sales volumes of registrants. "At the moment a company with a sales tonnage 10 times less than another is being charged the same fee, which is clearly unfair," says Marcus Susnik, UEAPME's specialist.on REACh.

Alterations or Additions may be Necessary

With other issues on which the Commission has ruled out action in the short term, it has acknowledged that alterations or additions to the REACh legislation may be necessary in the longer term.

On nanomaterials, which critics claim that REACh in its present form does not have powers to control, the Commission has said it will be looking at possible amendments to the legislation's annexes so that a draft implementing act can be put forward by December this year. It is also investigating the possible need to register certain types of polymers whereas at the moment only monomers have to be registered under REACh. If necessary, it will come forward with a proposal by January 2015.

The Commission is also stepping up its efforts to complete a list of substances of very high concern by creating a roadmap to assess and identify SVHC chemicals. It will set out clear milestones and a division of work between itself, ECHA and member states so that all relevant known SVHC are placed on the authorisation candidate list by 2020.

NGOs in particular have been sharply critical of what they perceive as slow progress in the listing of SVHCs. "It is deeply worrying that the Commission decided to measure ECHA's effectiveness by the number of papers shuffled, rather than by the number of dangerous carcinogenic substances taken off the EU market," says Tatiana Santos, senior policy officer for chemicals and nanotechnology at the European Environmental Bureau (EEB), Brussels.

Over the next five years of the implementation of REACh, the main measure of its success or failure to many people will be the number of hazardous chemicals, widely considered to be a threat to human health and the environment, which are substituted by safer alternatives.