ECHA finds that 70 percent of REACH registration dossiers are noncompliant.

After evaluating over 1,000 substance registration dossiers in the over-100 tonne per year band, the European Chemicals Agency (ECHA) found that almost 70 percent of the dossiers were noncompliant. Yesterday, ECHA announced the results of its compliance checks of 1,130 dossiers, comprising 5.7 percent of the registration dossiers over 100 tonnes submitted for the first REACH registration deadline in 2010. REACH requires the agency to check compliance for at least 5 percent of each tonnage band.

The agency identified two main causes for noncompliance: information deficiencies regarding the substance’s identification and composition; and missing data in chemical safety reports or insufficient justification for not submitting required studies.

ECHA’s Executive Director, Geert Dancet, described the completion of the compliance check as an “important milestone which helps all registrants to better understand their legal requirements.” Dancet also pointed out that the high noncompliance rate was not surprising since ECHA had targeted the compliance check on dossiers that had been electronically pre-screened for having “apparent shortcomings.”

ECHA has issued decisions as a result of the compliance check to registrants, who are required to submit the requested information. EU member states are responsible for enforcement of these decisions. ChemicalWatch notes that ECHA has declined to reveal either the companies or substances associated with the noncompliant dossiers, to the chagrin of certain NGO critics.

European Commission orders study of polymers for possible REACH registration requirements.

Polymers are currently exempt from REACH registration requirements, but recent actions taken by the European Commission (EC or the Commission) suggest that polymers might face a heavier regulatory burden in the future. Today, ChemicalWatch reported that the Commission has awarded a contract to study whether and how polymers should be subject to REACH registration requirements. The contract was awarded to Bio-Intelligence, a consultancy, in December 2013, and the study is expected to be completed by October 2014.

Article 138(2) of REACH empowers the Commission to present legislative proposals for selecting polymers for registration after finding a practicable solution and publishing a report on the matter. This report must cover risks posed by polymers in comparison with other substances; and the need, if any, to register certain types of polymers, taking into account factors including competitiveness and innovation as well as human health and the environment.

Last year’s REACH Review concluded that there was insufficient information to conclude whether certain types of polymers should be registered. In 2012, the consultancy RPA conducted another study for the EC on registration requirements for polymers. Taken together, the studies may for the basis for a new proposal on registering certain polymers.

REACH substance evaluation interactions to be improved.

At a recent meeting of the Competent Authorities for REACH and CLP (Caracal), member states, the European Chemicals Agency (ECHA), and industry agreed on steps to improve interactions between registrants and member state competent authorities (MSCAs) during the REACH substance evaluation process. Chemical Watch reported last week that a working group presented a paper making a series of recommendations on how to improve communication under the REACH Community Rolling Action Plan (Corap). The working group was established at a May meeting of ECHA and industry representatives and was led by Ireland and the European Chemical Industry Council (Cefic), among others.

According to Chemical Watch, the paper – which has not yet been released – makes various recommendations for substances listed on Corap year one, generally specifying which communications should occur at certain points throughout the evaluation process; e.g., evaluators should contact registrants shortly after publication of the Corap, and a mechanism should be developed to ensure that all registrants are informed of an impending evaluation. For substances listed on Corap years two and three, the paper recommends that evaluating authorities communicate clarifications on the substance evaluation process, while registrants should provide status updates on ongoing tests or planned dossier changes which might affect the evaluation.

The purpose of the recommendations, according to ECHA representative Claudio Carlon, is to “to increase clarity on the Corap process and explain what registrants need to do before it starts and post draft decisions, and encourage informal interaction between member states and registrants.” The recommendations were reportedly supported by attendees of the Caracal meeting. Industry groups including Cefic are planning to publish “a comparable initiative,” focusing on how industry can prepare for interactions with MSCAs during the evaluation process. This initiative will also address “interactions with downstream users.”

ECHA is expected to publish the working group’s paper with “minor amendments” by the end of the year or early 2014.

Scientists agree on EDC thresholds.

Scientists representing both sides of the Endocrine Disrupting Chemicals (EDCs) debate have agreed that thresholds for activity of EDCs may not exist. The conclusion is one of several reached during a recent meeting hosted by European Union (EU) chief scientific advisor Anne Glover in an attempt to identify areas of consensus and disagreement on the subject.

In the published minutes [PDF] of the meeting, the scientists say uncertainty about the existence of EDC activity thresholds—the exposure level or dose of a chemical above which toxicity or adverse health effects can occur—is due to experimental constraints and limited understanding of biological systems. They also agreed that defining EDC thresholds by in vivo experiments alone  is not possible. Rather, establishing whether thresholds exist must be defined by better understanding “the mechanisms of action in a quantitative systems approach.”

The scientists also agreed with the World Health Organization’s 2002 definition of EDCs and that criteria for identifying endocrine disruptors need to consider the disturbance of homeostasis at different stages of development. In addition, they agreed that non-monotonic dose response effects exist for some EDCs, both in in vitro and in vivo tests. However, although reliable study designs to find non-monotonic effects are available, the scientists say that more dedicated methods are needed to evaluate possible effects of EDCs on humans. Furthermore, they noted that validated OECD guidelines for testing do not cover all adverse effects or modes of action of EDCs.

Meanwhile, the German Chemical Industry Association (VCI), which recently published its opinion on EDCs, believes that EDC thresholds do exist, despite uncertainty, and any discussion about setting regulatory limits on EDCs should be viewed in that context. Furthermore, the association argued that while in vitro tests can be used in order to inform the mode of action for EDCs, they should not be used to derive regulatory thresholds. In vivo testing should be used to test for endocrine disruption since it allows scientists to more meaningfully investigate the complex interactions in the hormone system.

VCI also criticized the group’s conclusions on testing as overly pessimistic, since OECD guidelines cover the most relevant endpoints for EDCs and provide a solid foundation to test chemicals for their estrogenic, androgenic and thyroid-endocrine properties.

EU, U.S. TTIP negotiators discuss reducing chemical costs, regulating cosmetics.

Last week, U.S. and European Union (EU) negotiators held a second round of Transatlantic Trade and Investment Partnership (TTIP) discussions. During the week-long talks, negotiators examined how to reduce regulatory and industry costs for chemicals.

According to U.S. TTIP chief negotiator Dan Mullaney, a range of tools are available to reduce costs for chemicals and other sectors.  Ignacio Garcia Bercero, the EU’s chief negotiator, said specific ideas for cost reduction include harmonization of labeling requirements and better cooperation between the EPA and ECHA in performing risk assessment and exchanging data to avoid unnecessary testing. Bercero said the European and U.S. negotiating teams also discussed regulatory compatibility for cosmetics. Negotiators considered the feasibility of achieving “greater convergence” between the positive and negative lists of cosmetic ingredients in the EU and the U.S., which may be difficult since the U.S. allows certain cosmetic ingredients that are prohibited in the EU, said Bercero.

Meanwhile, NGOs have continued to express concerns over the lack of transparency in TTIP negotiations. Spokespeople from the European Consumer Organization (BEUC) and Friends of the Earth Europe said that open negotiations are necessary to ensure that the trade deal does not undermine or eliminate existing consumer legislation in the EU, as well as U.S. states like California with stricter chemical legislation. Both groups want access to the negotiating texts and regular consultations before and after each negotiating round. In response to NGO concerns, both Mullaney and Bercero said that talks on regulatory convergence in the chemical sector will not affect the level of protection or legislation under REACH or TSCA. The EPA has also stated that it does not believe TTIP negotiations will influence the agency’s “risk-based approach to chemicals management.”

The next round of TTIP negotiations will take place in Washington, D.C., between December 16 and 20.

Dutch survey finds SMEs struggling with awareness, cost of REACH.

A recent Dutch survey found that the costs of implementing REACH are much higher for Small to Medium Enterprises (SMEs) than previously thought and awareness among SMEs is lower than expected. The survey findings highlight just some of the major issues facing SMEs subject to REACH.

The Dutch survey, which is believed to be the largest national assessment yet of impacts of the Regulation on SMEs, interviewed 1,143 Dutch SMEs by telephone. The companies were selected on the basis of research that indicated they would be affected by REACH. The survey produced the following results:

  • Less than 30% of the companies had knowledge that REACH existed.
  • The cost of complying with the Regulation for SMEs was estimated to be €425m in 2012.  Jan Wijmenga, of the Dutch Ministry of Infrasture and Environment, said that the costs are much higher than originally expected, considering the estimate by the European Commission (“the Commission”) that REACH would cost companies €10 billion to implement in total, until 2018.
  • The cost of access to data is cited as the highest contribution to REACH expenses; however, this element is largely outside the remit of national member states and ECHA.

Although the survey was conducted for the Dutch Ministry of Infrastructure and the Environment, Mr. Wijmenga said that the survey would also be of interest to the Commission and ECHA. The survey highlighted certain priorities for REACH, such as developing simpler, easy-to-read guidance to the Regulation, clear information on how Substance Information Exchange Fora (SIEF) work, digitalization of safety data sheets, and greater consistency between REACH and other EU legislation. These priorities can be added to the list of the issues that have received attention since the end of the REACH registration deadline for tier two pre-registered, phase-in substances (100-1,000 tonnes) on May 31, 2013. Some of the major issues include:

  • The high cost of submitting dossiers, even for low tonnage bands. Much of the cost is due to laboratory studies (although some of this cost can be reduced by participating in SIEFs).
  • The practical problems SMEs face when participating in SIEFs, including the cost of letters of access, transparency, and the powers of lead registrants.
  • The number of companies falsely declaring themselves to be SMEs (which allows them to pay lower registration fees). In 2012, 62% of companies who had registered as SME were unable to demonstrate eligibility; 56% were considered not to be SMEs.
  • The time frame in which SMEs must respond to public consultations on EU chemicals legislation, particularly SMEs’ need for more time to process the information, given their often limited resources.

In particular, the survey findings will help supplement the Commission’s ongoing investigation of the impact of REACH on SMEs. A REACH review addressed the subject in February 2013, and this summer, the Commission’s Directorate-General for Enterprise and Industry (DG ENTR) put out a tender for technical assistance to further assess SMEs “in the context of socio-economic analysis under REACH.” The Commission also plans to hold a workshop on December 10-11, 2013, in Brussels, to further discuss the challenges faced by SMEs under REACH.

Efsa revises draft guidelines for food contact materials, calls for proposals to study implications.

The European Food Safety Authority’s (Efsa) Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) recently drafted revisions to its guidelines [PDF] for food contact materials (FCMs), incorporating new data requirements that could lead to substance re-evaluations. In response, Efsa’s Food Ingredients Packaging (FIP) unit has launched a call [PDF] for proposals to study the implications of the revisions.

The guidelines specify the data that must be submitted with applications for safety assessments of substances to be used in FCMs prior to authorization by the European Commission. CEF revisited the guidelines in light of recent scientific developments, opinions issued by Efsa, and experience gained from safety evaluations of many different substances. In the revisions, CEF proposes carrying out “an exposure assessment using a harmonised methodology” established by Efsa. The assessment would take into account specific consumption by subgroups of the population, such as infants and toddlers, in contrast to the current approach, which uses a single value. The CEF panel also suggests setting standardized consumption data for a number of food categories.

The exposure-based approach proposed by CEF could result in different requirements for submission of toxicological information and use restrictions for certain substances. Therefore, Efsa “considers it necessary” to assess the implications of the draft revised guidelines and the differences from the current guidelines, as specified in the call for proposals.

The draft revised guidelines are not yet publically available. The CEF panel plans to adopt the revisions at its plenary meeting next week, after which the guidelines will be released for public consultation.

Biocidal Products Regulation Enters Into Force in EU.

The Biocidal Products Regulation (BPR; Regulation (EU) 528/2012), which repeals and replaces the Biocidal Products Directive (BPD, 98/8/EC), entered into force on September 1, 2013. The BPR retains the legal framework established by the BPD, including the two-tier approval system for biocidal substances, but also introduces a number of new provisions, such as those relating to treated articles and food contact materials containing biocides.

In order to prepare applicants for the new changes, ECHA recently published priority guidance on applying information requirements for biocidal active substances (Annex II) and biocidal products (Annex III). The head of ECHA’s biocides unit, Hugues Kenigswald, says that there are a number of further documents in development that will complement it. However, applicants can begin submitting biocidal and technical equivalence dossiers immediately.

Unless they are included in ECHA’s list of approved active substance suppliers, all manufacturers or importers of active substances contained in biocidal products must submit a dossier before placing products on the market. Applicants can prepare a dossier by using the first versions of BPR submission tools, the Iuclid report generator software and the R4BP3 register for biocidal products. The ECHA has published guidance for using these tools on their website.

Some in the industry worry that the submission process, particularly the Iuclid software, will be too complex for companies. Yet overall, industry is expected to benefit from the Regulation, which will allow industry to request an EU-wide authorization for biocidal products, thereby removing national barriers to trade. This simplified and more efficient product authorization, along with data sharing and information requirements, is estimated to save industry € 2.7 billion over a period of 10 years. However, Mr. Kenigswald did express concern as to whether member states will have enough resources to provide the support needed to make the BPR an effective Regulation.

New EU Cosmetics Regulation To Take Effect in July 2013.

On July 11, 2013, the new European Union (EU) cosmetics Regulation (EC 1223/2009) will fully replace the existing cosmetics Directive (76/768/EEC) that has applied since July 27, 1976.  Unlike the previous EU cosmetics Directive, the self-executing Regulation unifies the cosmetics requirements of the European Economic Area (EEA) into a single law and eliminates ambiguities that may occur among EU member states during the enforcement process. The new Regulation, which applies to all EU cosmetics companies, is intended to ensure that consumers’ health is protected and that they are well informed by monitoring the composition and labeling of cosmetic products.

The Regulation is focused on simplifying procedures, streamlining terminology, and strengthening certain elements of the regulatory framework for cosmetics. The main changes it introduces include:

  • creating a new, electronic, centralized system that will replace the current national competent authority notification process
  • clarifying the format and content of the product information file (PIF) to be used in conducting a product safety assessment; particularly, the PIF must include data to support any claims made about a product
  • narrowing the “exceptional cases” when substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMRs) can be used
  • requiring the presence of nanomaterials in cosmetic ingredients be clearly indicated by the word “nano” in brackets
  • requiring cosmetics companies to designate a legal or natural person within the EU—known as a “responsible person”—whose role will be to ensure certain safety requirements for each cosmetics product introduced on the market

The Regulation also continues the previously established ban on animal testing, which came into full force through the Cosmetics Directive on March 11, 2013. Although the inclusion of the ban has been applauded by many consumers and animal welfare groups, it has also raised some concerns in the cosmetics industry about the potential negative impact on innovation due to the inability to fully test new ingredients as well as potential conflicts arising from the testing requirements imposed by other regulations. The European Commission has posted an impact assessment [PDF] online that discusses the various effects of the ban.

Notable milestone reached by the Regulation en route to becoming applicable, exclusively, to cosmetics placed on the EU market include: prohibiting use of CMR 1A/1B/2 substances in cosmetics, although certain CMR 2 substances may be exempted by the EU Scientific Committee of Consumer Safety (SCCS) after assessment; submission of all cosmetics through the new centralized notification system; commencing the  notification process  for nanomaterials already on the market.  All cosmetics are expected to be fully compliant with the new Regulation by July 11, 2013.