EU Makes Progress On REACH Enforcement Indicators

« Forum set for trial; member states have some concern.

The European Commission has made progress on the enforcement indicators it is developing. Speaking at Chemical Watch’s Enforcement Summit in Brussels, Miguel Aguado-Monsonet, policy officer at DG Grow, said that it appeared the process to calculate enforcement indicators at EU-level works. However he said further work is needed regarding both the data collected and calculations used.

Around 2,000 pieces of data have been collected to generate 12 EU-wide indicators from the 31 countries enforcing REACH and CLP. Some of that information has come from the REACH Article 117 reports that EU member states make every five years – the latest cycle required reports to be submitted in June this year.

According to the results, the average degree of compliance for REACH and CLP is 80 % across the EU, based on all types of inspection.

As a caveat, Mr Aguado-Monsonet said that this figure did not mean that the market is 80 % compliant, as enforcers often used intelligence to focus their activities on likely cases of non-compliance, which would push the percentage up.

Other EU indicators are:

  • penalties;
  • training; and
  • the number of complaints made against enforcement.

The Commission plans to combine the figures to come up with an overall indicator of enforcement. 2010 will be used as a base line.

It has been working with Echa’s Enforcement Forum to develop three sets of indicators. In addition to the EU-wide set, 16 have been proposed for both the Forum and for member states to use at national level.

The Forum is scheduled to discuss the indicators at its meeting in November, says its deputy chair Eugen Anwander. He expects the members to come with data to feed into the indicators to get a feel for how they would work.

He noted that some member states are cautious about the national-level indicators, adding that context will be needed to explain why figures differ between countries. For example, he said some countries do a lot of research to seek out cases of likely non-compliance before approaching companies, while others preferred to make spot checks. The data for these different approaches would probably show much higher success rates in the first case compared to the latter.

Mats Forkman, head of unit enforcement and registries at the Swedish Chemicals Agency (Kemi), said measuring the number of inspections carried out by a national enforcement authority would not necessarily show the true picture and effectiveness of the work carried out. For example, he asked, how the indicators would distinguish between inspections of “a distributor selling truckloads of chemicals … and a small newsagent.

“We want to ensure a good outcome, which is a high level of [protection for] human health and the environment. It is not about ensuring a high number of inspections. It could help but I have some concern that the numbers [set out in the indicator] will take over.”

UK Health and Safety Executive inspector Mike Potts said the indicators are “helpful”, particularly because inspectors in the UK have to report to their managers about how they conduct their work. However, he agreed there are concerns around using inspection numbers as an indicator, and that it was “important that we are clear on what those numbers mean. If I carry out 100 poor inspections or 20 good inspections – which is better?”

He said people should be aware of “exactly what the numbers mean” and not to view them as a league table.

Mr Aguado-Monsonet said that by collecting and using similar data to evaluate enforcement, the indicators aim to provide a better knowledge of REACH and CLP enforcement, and contribute to a more harmonised approach across the EU.

He said the preliminary results showed that work still needs to be done to ensure the results are robust, and further discussions are needed with the Forum, member states and within the Commission regarding the interpretation of the results.

The final results are expected to be used in the 2017 review of REACH. »


Article of Emma Chynoweth and Leigh Stringer
Indicators report :

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Ciel, Öko-Institut and Ecos Make Joint Proposals on Nano

« Characterising nanoparticles is key, say bodies.

Proposed REACH annex amendments for nanomaterials need more detail, according to a position paper by the Centre for International Environmental Law (Ciel), the European Environmental Citizens Organisation for Standardisation (Ecos) and the German Öko-Institut.

As pressure grows for the European Commission to revise REACH annexes for nanomaterials, the paper discusses the Commission’s proposed amendments, as presented to the competent authorities’ sub-group on nanomaterials (CASG-nano) in 2014 .

The organisations welcome the inclusion of a nano definition in REACH Annex VI. However, they point out that proposals for characterising nanoforms only cover minimum requirements. “Important information is missing”, including particle-size distribution outside of the 1nm to 100nm range, says the paper.

Surface chemistry and charge, and whether particles form clumps and clusters, during use and release, should also be considered, it adds. It also points out that information on surface treatment, coating or functionalisation remains “extremely limited”, despite being relevant for risk assessment.

The position paper refers to a 2014 study by Risk and Policy Analysts (RPA), pointing to a lack of nanoform information in registration dossiers.

Last week, Geert Dancet, head of Echa, said that 40% of dossier compliance check decisions are currently appealed and that some companies are even challenging the premise that REACH covers nanoforms.

Ciel and partners suggest that physico-chemical and (eco-)toxicological information should be included in registration dossiers, when nanoforms are used in consumer products. “With this amendment, an important loophole regarding the risk assessment for most of the existing nanomaterials … would be closed,” they write.

Nanoparticles should be fully characterised before grouping for read-across and toxicological assessment, stresses the paper. “Allowing the grouping for (eco)toxicological assessment of non-characterised nanoforms would defeat the purpose of most of the proposed amendments,” it says. “It is scientific nonsense to group several uncharacterised materials for the purpose of hazard assessment.”

At its 15th meeting on 4-7 November, the OECD’s Working Party on Manufactured Nanomaterials (WPMN) will discuss a progress report on physical-chemical properties for grouping for read-across. It will also wrap up case studies on exposure assessment for gold and silver nanoparticles.

The main focus of the meeting will be to plan the WPMN’s programme of work for 2017 to 2020. To help with this, the working party will hear presentations from various delegations, explaining particular policy challenges, said chair Peter Kearns.

At the meeting, the WPMN will also begin to review the OECD Council recommendation on the safety of nanomaterials, last agreed in 2013.

CASG-nano’s last meeting was in December 2014 . « 

Article of Emma Davies
Position paper :
RPA report, 2014 :

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ECHA Says BoA Sonc Decision is Case- Specific

« Agency plans to inform registrants of dossier evaluation outcomes next year.

ECHA says it considers that a decision by its Board of Appeal (BoA), regarding a statement of non-compliance (Sonc), following a dossier evaluation decision, only applies to the specific case between the appellant and itself.

In its decision on the case – finalised in August– the BoA said the agency should have followed the decision-making procedures outlined in REACH Articles 50 and 51 when issuing the Sonc. This enables the registrant to comment before the Sonc is issued.

Speaking at Chemical Watch’s Global Enforcement Summit in Brussels, Ofelia Bercaru, head of unit in Echa’s directorate of evaluation said: “We don’t see reason to withdraw other Soncs.”

She said the agency considered the case was particular as it applied to a notified new substance (Nons) dossier submitted originally to the Belgian authorities under legislation preceding REACH.

However, she added that the agency plans to initiate a discussion with the Competent Authorities for REACH and CLP (Caracal) and the Enforcement Forum. This will be to see whether adjustments are needed to the Sonc step within the dossier evaluation process.

Ms Bercaru said the REACH evaluation process seems to work well. She noted that out of the 600-plus dossiers evaluated so far, around 80% achieved compliance based on the evaluation decision. A further 10% had become compliant after a Sonc had been issued. Some 56 Soncs are pending.

Ms Bercaru said registrants have the opportunity to comment to Echa during the dossier evaluation decision-making. And many do, to discuss issues such as:

  • deadlines;
  • progress on testing; and
  • requesting advice.

However, once a decision is issued, she said, Echa cannot modify it, adding: ”If [the registrant] is not happy, it can submit an appeal.”

She added that a Sonc is a way of transferring authority to the national bodies responsible for enforcement. Echa does not have the competence for enforcement. “A Sonc is a way to put everyone on an equal footing on the same information,” she said.

Meanwhile, Echa is planning to inform registrants on the outcome of the follow-up to dossier evaluation from next year. Some companies have asked to know if their dossiers have successfully completed this follow-up process. Ms Bercaru said that Echa will send out a statement. But, she added, this would not mean another compliance check cannot be started on another issue. »


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ECHA Forum Prepares Restriction Enforcement Tools

« Compendium of analytical methods, guidance on results interpretation to be published.

Echa’s Enforcement Forum is preparing several guidance documents and tools, to help national enforcement authorities and companies assess whether articles comply with REACH substance restrictions.

The area has been fraught with difficulties, for many years, because of the lack of officially recognised test methods for checking if a material meets the concentration limits and migration levels set in REACH restrictions, and other regulatory instruments.

This means different laboratories use different analytical methods, while varying sampling methods can also contribute to a wide disparity in test results.

However, the first edition of a compendium of analytical methods is due to be published on Echa’s website by the end of the year, according to Enforcement Forum member, Maria Letizia Polci.

Speaking today at Chemical Watch’s Enforcement Summit, Ms Polci, who works on REACH enforcement for Italy’s health ministry, said the compendium will include 138 recommended methods for 41 restriction entries, and that the forum will invite interested parties to submit additional information for future editions.

Another challenge for enforcement authorities, she said, includes the broad scope of restrictions, which may cover a large number of mixtures and articles.

The forum is also developing guidance on the interpretation of analysis results and hopes to publish information in 2017. This will be on the lessons learned from next year’s Ref-4 coordinated enforcement project on restrictions.

Meanwhile, the European Standards Organisation (CEN) will develop analytical methods for determining the lead and polycyclic aromatic hydrocarbons (PAHs) content, and migration levels, in consumer articles and for chromium compounds in leather goods. Future annual CEN work programmes will include other analytical methods, said Ms Polci.

In addition, the European Commission’s taxation and customs directorate, DG Taxud, is drawing up a correlation table, which will list the mixtures and articles, which may contain a restricted substance, together with the appropriate CN or Taric codes. The Commission will create such codes, for articles without them. »

Article of Geraint Roberts

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EU Commission Announces Seurat 1 Symposium Programme

« The European Commission has announced the official programme for its Seurat 1 symposium, taking place on 4 December in Brussels.

The event will be an opportunity to learn about recent achievements in the field of non-animal testing, and about future initiatives, it says.

The registration deadline for « Painting the future animal-free safety assessment of chemical substances: achievements of SEURAT-1 » is 9 November. »

Symposium programme :
Event page :
Registration form :

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German Environment Ministry Outlines REACH Priorities

« Top official says ‘protect’ it from TTIP, improve dossier quality.
The environment ministry of Europe’s biggest member state has spelled out its priorities for protecting the achievements of REACH, and improving its implementation.

Speaking at yesterday’s conference in Brussels on the future of REACH, organised by nine European countries, Alexander Nies, deputy general of Germany’s federal environment ministry (BMUB), said European governments must “protect” the hazard-based elements of REACH, and its placing of the burden of proof of chemical safety on industry, from TTIP, the current EU-US talks on a new trade agreement.

His comments were echoed by Monique Goyens, head of European consumers group Beuc, who described TTIP and the European Commission’s Better Regulation programme as a “toxic cocktail” that threatens to “further delay regulation on chemicals in Europe”.

In contrast, Cefic director general Hubert Mandery called for increased cooperation with the US on chemicals, through the TTIP talks.

The BMUB is also concerned about the quality of registration dossiers, said Mr Nies, especially for endpoints such as reproductive and developmental toxicity. “Standard animal testing is the exception. But the alternative information provided is insufficient, in many cases, for most high tonnage substances,” he said.

Echa must “intensify” its dossier compliance checks and target the most important endpoints. It must also “communicate more clearly the extent to which animal testing is indispensable”, even though “this is an uncomfortable message – industry doesn’t like it, and the animal welfare NGOs certainly don’t like it.”

On authorisation, Mr Nies said that although the process was broadly working, discussion of possible changes was needed. The weighing of the economic benefits and risks of a particular use of a substance, he said, is a political task, not a scientific one, and is, therefore, not a task for Echa.

As well as registration dossier quality, a number of common themes were raised by most of the conference speakers. These included how to: help the substitution of SVHCs; weigh the need to increase material recycling against the need to restrict SVHCs and other hazardous substances; move forward on nanomaterials and endocrine disruptors; and make REACH work better for SMEs and downstream users.

An issue mentioned by competent authorities, industry and NGOs was the need to remove the competitive disadvantage faced by companies in Europe, regarding banned substances in articles. The problem is twofold: imported articles, containing restricted substances, are still appearing on the EU market; and the phase out of Annex XIV substances does not apply to imported articles.

Germany’s Environmental Protection Agency (UBA) says it would be legally possible for the EU to extend the applicability of Annex XIV to imported articles, without infringing free trade law. »


Article of Geraint Roberts
Cefic press release :
Cefic Director General Hubert Mandery’s presentation :

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« Better Regulation Agenda Delaying REACH Implementation » Says EEB Head

« The European Commission’s “obsession” with its Better Regulation agenda is delaying the implementation and enforcement of REACH, says Jeremy Wates, secretary general of the European Environmental Bureau (EEB).

In the margins of yesterday’s EEB’s annual conference, Mr Wates told Chemical Watch that “unsubstantiated complaints from industry” about REACH costs should not be allowed to stop the regulation from achieving its goals of protecting human health and the environment.

The European Commission’s Better Regulation agenda is “at the heart of this delay”, he said. This, according to the Commission, aims to “design EU policies and laws that achieve their objectives at minimum cost”.

Mr Wates said that despite the Commission’s assertions to the contrary, this agenda suggests cuts to the “regulatory safety net that protects consumers, citizens’ health and their environment”.

The Commission is currently reviewing REACH‘s impact on businesses. It recently revealed that 35 % of 1,600 companies responding to a survey said REACH is negatively impacting their capacity to innovate.

Earlier this week, the EEB released a report from its 40th anniversary conference held last December.

It says that efforts to improve chemical safety are facing “strong push back” from industry.

“Implementation of REACH is happening at too slow a pace and key issues such as endocrine disrupting chemicals, cocktail effects and toxicity of nanomaterials remain unresolved,” it says. »


Article of Leigh Stringer and Geraint Roberts
EEB report :

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