EU Commission Publishes REACH Review

The EU Commission has fulfilled its obligation to review the REACH program. It published its REACH review on February 5, 2013. The 15-page document concluded:

"that REACH functions well and delivers on all objectives that at present can be assessed. Some needs for adjustments have been identified, but balanced against the interest of ensuring legislative stability and predictability, the Commission will not propose any changes to the enacting terms of REACH."

They did, however, determine that there is a need to reassess the impact of REACH on small and medium sized entities (SMEs), which because of their relative low benefit compared to the high costs of compliance the Commission felt have still been unduly impacted despite reduced fees and testing obligations.

A summary of the report can be read here.

The prepublication version of the report can be downloaded here as a PDF.

ECHA Strengthens Compliance Check Strategy

From the European Chemicals Agency (ECHA):

"To ensure increased compliance of REACH registration dossiers, ECHA carries out both full compliance checks of the dossiers and now more effectively also targets its evaluation to specific parts of them.

In a full compliance check, ECHA addresses the full dossier content in a single evaluation exercise, especially for randomly selected registration dossiers. This means that ECHA performs a systematic evaluation of all information requirements in the technical dossier (e.g. physico-chemical, environmental and human health endpoints), including the corresponding elements and conclusions provided in the chemical safety report (i.e. PBT/vPvB assessment, classification and labelling, exposure assessment and risk characterisation). Where a dossier is non-compliant with an information requirement, ECHA will request the information in a single decision. The decision is taken in cooperation with the Member States.

In a targeted compliance check, ECHA evaluates only a specific part of the registration dossier based on specified concerns. Selected (groups of) endpoints or criteria, called areas of concern, have been identified that are in particular relevant for the safe use of substances.  The ultimate goal is to focus on those endpoints that matter for human health and the environment. Emphasis will be given to Persistent, Bioaccumulative and Toxic (PBT);  Carcinogenic, Mutagenic or Toxic to reproduction (CMR); or sensitising (S) properties of a substance. IT-assisted targeting combined with expert judgement will help to achieve the necessary increased compliance of the registration dossiers. The chances of non-compliant dossiers being picked up for compliance check are now higher. Dossiers submitted individually outside an existing joint submission and dossiers with obviously incomplete essential elements will be automatically selected for compliance check."

The full press release can be read here.

ECHA to make more data on chemicals available

According to an ECHA news release:

"Beginning in November, ECHA will make more information from registration dossiers available on its website. This will implement a decision taken by ECHA in 2011 and is in line with Article 119(2)d of REACH. With these new elements, information made available will include the name of the registrant, the registration number of the substance as well as other items normally contained in a Safety Data Sheet (SDS). Companies wishing to request confidentiality on these items need to update their dossiers and justify their requests for confidential treatment."

 More information can be found on the ECHA web site.

New EU Biocide Regulation Enters Into Force

The new Biocidal Products Regulation (BPR) enters into force in the EU today, July 17, 2012. The BPR replaces the Biocidal Products Directive (BPD) that had been the law governing biocides. There will be a transition period for some biocidal products already in the review process, but the new BPR moves much of the responsibility for approving biocides to the European Chemicals Agency (ECHA).  ECHA is also responsible for REACH, the chemicals regulation.

As a regulation, the BPR goes into force in all of the EU immediately.  The previous Directive had to be implemented by individual member state action.

More information on the new Biocidal Products Regulation can be found on ECHA's web site.

ECHA Drops Proposal to Restrict Four Phthalates

The European Chemicals Agency (ECHA) has dropped its plan to restrict the use of four phthalate chemicals. The proposal had been put forth last year on the chemicals commonly called DIBP, DBP, BBP, DEHP.  However, after review an expert committee determined that the proposed restrictions could not be justified, ECHA last week retracted the proposal.


Denmark had asserted in 2011 that the four phthalates could affect sexual development.  The expert committee disagreed - they noted that the "available data does not indicate that there is currently a risk from combined exposure to the four phthalates." The committee also concluded that regulatory actions already being put into place would result in significant reduction of exposures, thus making the proposed restrictions somewhat redundant, yet overly punitive.


The decision is the first time the expert committee has refuted a proposed restriction from ECHA.  


A summary of the Danish report can be read here.

The full proposal can be downloaded here.

ECHA to Update REACH-IT and IUCLID 5 Software for REACH Chemical Assessments

According to an ECHA press release:

The European Chemicals Agency (ECHA) is going to release a new version of IUCLID 5 in late May 2012 and subsequently a new release of REACH-IT. Later this year, ECHA will start publishing more information on chemical substances.

Helsinki, 11 April 2012 - The new IUCLID 5.4 release will bring about changes mainly on how certain substance information included in the Chemical Safety Report (CSR) is reported. In addition, certain information included in the Safety Data Sheet (SDS) will be made publicly available. As a continuation of the IUCLID 5 update, a new version of REACH-IT will be released later in the summer. The new REACH-IT release will accept only IUCLID 5.4 dossiers. ECHA publishes a Question and Answer (Q&A) document to inform stakeholders in advance about the impact on the upcoming submissions of registration and other dossiers.

More information

Many REACH Registrants Not in Compliance, Says ECHA Forum

Ever since the first REACH registration deadline of November 2010 ECHA has been doing inspections to see if registrants properly complied with the data and reporting requirements of REACH.  The answer is often - NO.  Recently the second report of ECHA's REACH Enforcement Forum estimated that about 20% of the companies they looked at were not in compliance.  In the first report the Forum had identified 24% compliance for the earlier group of companies inspected.

Most of the non-compliance was related to failure to comply with the new Safety Data Sheet requirements or failure to correctly register their substances.  Sometimes this meant no registration was submitted at all, other times there was a lack of preregistration, and in still others the company preregistered but did so incorrectly.  Possible penalties for non-compliance could include loss of registrations, public shaming of companies with multiple non-compliance, fines, and criminal complaints.


The report will be available on the ECHA web site.

ECHA to Delay Launch of CLP Classification Inventory

This just in from the European Chemicals Agency (ECHA) in Helsinki:

"ECHA has decided to delay the launching of the Classification and Labelling Inventory in order to ensure that the information provided by industry will be made publicly available in an accurate way that allows easy and functional access and navigation. The Agency will announce the new launch date by mid January. This is a key milestone project for ECHA because the public will have, for the first time, access to information on the self-classification of chemical substances by Industry."

ECHA to Begin Authorizing Biocidal Products

The European Union has reached an informal agreement to allow the European Chemicals Agency (ECHA) to being taking responsibility for reviewing and authorizing biocidal products.  The agreement between the European Parliament and the EU Council would give broad powers to ECHA and update the current EU Biocides Directive.

In addition to allowing ECHA to review certain biocides applications at the EU level, companies would also maintain the ability to apply to individual Member States for authorization, after which they would obtain approval in other Member States through a process called mutual recognition.  This is how the process works under the current Directive, and this move to shift some of the responsibility to ECHA is part of the reevaluation of the Biocide process as the Directive is replaced by a Biocidal Products Regulation.  Like REACH, the new regulation would immediately apply across all Member States, whereas the Directive required each MS to pass its own individual implementation legislation.

ECHA's role is limited to only some of the product types of biocides beginning in 2012, and then by 2017 all of the 23 product types will be eligible for authorization at the EU level through ECHA.  The informal agreement also specifically requires that nanoscale active substances in biocidal products be assessed separately from their non nanoscale counterparts.

EU Commission to Ban Biocide Uses for Eight Chemicals

Last week the European Commission issued a decision "concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC," i.e., to ban specific uses for eight biocidal chemicals.  The decision gives manufacturers and formulators until July 1, 2012 to phase out use of the substances for the biocidal product types indicated.  After that date they will be banned from being placed on the market.

The substances and product types for which they will be phased out are:

Formaldehyde: Human hygiene products, drinking water disinfectants, fibre/leather/rubber materials, vermin

2-Chloroacetamide: Veterinary hygiene products, in-can preservatives, metalworking fluids preservatives

Thiabendazole: Private and public health area disinfectants, metalworking fluids preservatives

2,2'-dithiobis[N-methylbenzamide]: metalworking fluids preservatives

Sulphur dioxide: Human hygiene products, private and public health area disinfectants, in-can preservatives, film preservatives, metalworking fluids preservatives

Reaction product of dimethyl adipate, dimethyl glutarate, dimethyl succinate with hydrogen peroxide/Perestane: Food and feed area disinfectants

Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride): Human hygiene products, drinking water disinfectants, in-can preservatives, metalworking fluids preservatives


Poly(hexamethylendiamine guanidinium chloride): Human hygiene products, drinking water disinfectants, in-can preservatives, metalworking fluids preservatives

Any other uses not listed are still authorized to continue beyond the phase out date.  In all cases, the uses above were not supported by the manufacturers.

EU Science Committees Call for Comments on How REACH Can Handle "Chemical Mixtures"

Three scientific committees of the European Commission have issued a "preliminary opinion" on how REACH and other chemical regulations can address the risks of chemical mixtures.  The three committees -  the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) - are now opening a public consultation and asking for feedback on the document, "Toxicity and Assessment of Chemical Mixtures."

REACH, the European chemical regulation, is a substance-based law, though some substances as defined can include mixtures of either discrete or variable composition chemicals.  Still, there is concern that mixtures of chemicals, sometimes called "chemical cocktails," could have greater toxicity than the sum of the toxicities for the individual chemicals.  This paper by the three committees attempts to address this concern, though no new amendments to the REACH law were proposed at this time. 


According to the press release, the main conclusions of this preliminary opinion are:

• Chemicals with common modes of action may act jointly to produce combined effects that are larger than the effects of each mixture component alone.
• For chemicals with different modes of action (i.e. acting independently), no robust evidence is available that exposure to a mixture of such substances is of health concern if each individual chemical is present at or below their no effect levels.
• For chemicals that interact, interactions (including antagonism, potentiation, synergies) usually occur at medium or high-dose levels (relative to the lowest effect levels). At low exposure levels they are either not occurring or toxicologically insignificant.

The deadline for comments is September 9, 2011.  Commenters are asked to use a special web site to assist the EU in compiling what they expect to be a significant number of comments.

European Commission Will Not Seek New Legislation for Nanomaterials

At a meeting of the European Commission this week commissioners confirmed that the EU plans to deal with  nanoscale materials primarily through its REACH chemical regulation rather than develop entirely new legislation specific to nanomaterials.  Commissioners noted that creating something new was simply not feasible at this time.

The Commission will, however, work with ECHA and other regulatory bodies to develop additional guidance documents to assist stakeholders in adequately characterizing and evaluating any specific risks posed by nanoscale materials.  While most nanomaterials are nano-sized versions of existing chemicals, the small size often results in differences in key physical-chemical, fate and transport, and potentially toxicity properties.  The goal is to find a balance between the need for additional information for the risk assessment and creating a massive new regulatory burden for companies, many of whom may be small or medium sized entities.

At this point there is quite a bit of uncertainty for industry, which must deal with a regulatory system that isn't yet predictable or consistent.  Even the definition of what the regulatory bodies believe constitutes a nanomaterial is not clear. Still, industry is generally in agreement that nanomaterials should be dealt with through REACH rather than have to deal with entirely new legislation.

Environmental Groups Sue ECHA for Refusing to Release Names of Chemical Manufacturers

Two European environmental groups have sued the European Chemicals Agency (ECHA) for refusing to release the names of chemical manufacturers and importers of some of the most hazardous chemicals in the EU.  The lawsuit claims "several violations of European laws designed to promote transparency, democracy, and legitimacy in EU policy-making."  ChemSec, a Swedish-based NGO, was joined by environmental law organization ClientEarth in filing the suit.

The chemicals in question are the 356 chemicals on ChemSec's "SIN (Substitute it Now!) list."

The list comprises chemicals identified as Substances of Very High Concern under the EU chemicals regulation REACH. These are chemicals that can cause cancer, damage our reproductive system, or alter our DNA, as well as toxic substances that accumulate in nature with serious and long-term irreversible effects.

Last week I reported that ChemSec had added 22 chemicals to their SIN list based on their potential endocrine disruption effects.  Under the EU chemical control law, REACH, ECHA is required to give special attention to these "substances of very high concern." In their lawsuit, ChemSec and ClientEarth argue that:

ECHA has a track record of being slow to disclose information about chemicals; pressure from the chemicals industry has so far been successful in making delays characteristic of the Agency's approach, despite this policy's clear contravention of REACH and EU principles established for almost 20 years.

According to Vito Buonsante, toxics lawyer at ClientEarth: 

The public’s right to information on chemicals is a basic principle of the REACH Regulation. ECHA must not be allowed to withhold information on such a critical issue, especially as it relates to chemicals found in consumer products and present in the EU in large quantities. We have exhausted all avenues to make ECHA meet its transparency obligations and are now compelled to go to court.

More information on the lawsuit can be found on the ChemSec and ClientEarth web pages.

European Chemical Association Establishes Five REACH/CLP Platforms

The online publication, Chemical Watch, has noted that the European Chemical Industry Council, better known as Cefic, has undertaken an internal restructuring in order to best handle the changing needs of its REACH and CLP industry clients.


According to Chemical Watch, Cefic's new "platforms and their responsibilities" are:

• Registration – focusing on guidance and registration related topics for the next deadline in June 2013 and issues relating to SMEs.
• Dossier Compliance – embracing the aspects of evaluation, including the dossier compliance check and testing proposals, and enforcement.
• Restrictions and authorisation – looking at different aspects ranging from the initial proposals set out in Annex XV dossiers, through to Annex XIV Candidate List proposals and the granting of authorisations, which Mr Annys notes is now starting to be discussed in detail. He said the ECHA authorisation workshop earlier this month was a good first exchange of information and opportunity to understand what ECHA and the Commission expected companies include in their authorisation applications. He predicted that the newness and complexity of the process would likely mean the bulk of applications will come closer to the application date, rather than earlier on. He adds that the upcoming substance evaluation process, set to begin in 2012, will likely be closely related to the authorisation and restriction.
• CLP and GHS – dealing with issues such as harmonised classification and labelling, how to develop common C&Ls, and safety data sheets.
• Global Product Strategy – to fulfil industry’s commitment to meet the requirements of the Strategic Approach to International Chemicals Management

More information on Cefic's changes can be found in the Chemical Watch article (available at the above link by subscription only) and on the Cefic site.

More information about the publication, Chemical Watch, can be found on their web site.

ECHA Provides Tools to Help Chemical Companies Prepare Authorization Applications for REACH

Now that the first deadline for REACH registration has passed, and responsible parties at registering companies have had a chance to take a vacation and catch up on other work, it's time for some companies to turn their attention to the "A" in REACH - Authorization.  And the European Chemicals Agency (ECHA) has now provided some tools to help companies do just that.

Authorization, of course, is the part of REACH where ECHA has determined that a particular "substance of very high concern" presents too great a risk and therefore intends to remove it from commerce.  Manufacturers of those chemicals put onto Annex XIV of REACH, the authorization list, must apply to receive authorization to continue using the chemical.  If no authorization is granted the chemical will be banned from commerce in the EU at the end of the specified sunset perios, which for the handful of chemicals added so far is 2014 or 2015.  If authorized, the chemical would be limited to uses that are critical and can be controlled, and where there are no available substitutes, and for only a limited period of time allotted to find or develop a substitute.

The new tools include "templates to document an analysis of alternatives, a socio-economic analysis and a substitution plan."   There is also a "Fee Calculator" to estimate how much it will cost to submit their application (but not how much to prepare the application). There are also a new Data Submission Manual that "explains in detail how to prepare an Application for Authorisation using IUCLID 5.3, and how to use the web forms for dossier submission."

More information is available on the ECHA web site.

Guidance on how to prepare the authorization application can be downloaded as a PDF here.

Guidance on how to prepare the socio-economic analysis can be downloaded as a PDF here.

UK Intends to Stop Animal Testing on Household Products - Animal Rights Groups Rejoice

Recently the UK government signaled that it would end animal testing for household products.  And at least one animal welfare group has expressed its pleasure.  The British Union for the Abolition of Vivisection, more popularly known as BUAV, said that they welcomed "a statement made by Home Office Minister, Lynne Featherstone that the Government intends to ban the animal testing of both finished household products and their ingredients." 

BUAV notes that the "statement comes in response to a Parliamentary Question tabled by Adrian Sanders MP on March 28th 2011" and that the ban will include “all products that are primarily intended for use in the home, including detergents and other laundry products, household cleaners, air-fresheners, toilet blocks, polishes, paper products such as infant nappies [i.e., diapers], paints, glues (and removers), other furnishing and DIY products and household pesticides.”

Governments and animal welfare groups around the globe are working on ways to reduce or eliminate animal testing of chemicals.  I have discussed before how organizations are working to develop alternative testing methods.   Current protocols for testing chemicals and products involve doing in vivo, that is, in life, tests using various animals - mostly mice, rats and rabbits - as surrogates to assess toxicity.  So while some NGOs argue that more testing is necessary to characterize the hazards of chemicals, animal welfare groups argue that such animal testing is both cruel and unnecessary.

For more about BUAV you can check out their web sites: BUAV and Go Cruelty Free.

European Chemicals Agency (ECHA) Meets Deadline for Chemical Dossier Completeness Checks

The European Chemicals Agency (ECHA) has reported that it has met its statutory obligation to finish "completeness checks" on chemical dossiers submitted for REACH registration.  REACH required ECHA to complete these reviews within three months following the deadline, which for the first group was November 30, 2010.  The completeness check requirement applies only to registrations for phase-in substances submitted in the last two months before the first registration deadline.  A total of 15,366 dossiers were submitted during that two month period.  According to ECHA:

Registration numbers have been granted for 20 175 of the 20 723 dossiers that were submitted by the first registration deadline, resulting in a total of 3 483 phase-in substances being registered under REACH. Dissemination of information from these dossiers has been accelerated.

The completeness check is only to "check that all required elements have been provided," i.e., that some data are there.  Much of this check is done automatically and registrants can pre-check their dossiers using a Technical Completeness Check (TCC) tool made available to all via the ECHA web site.  ECHA then repeats the TCC upon receipt and also may check other business rules.  This completeness check is different from a compliance check, which involves ECHA staff actually reviewing the substance of the data submitted.

Information about the chemicals registered and access to dossiers once they have been disseminated can be found here.

First Set of Chemical Substances Ready to be Phased Out (aka banned) by Europe's REACH

The first six chemical substances to be given the hangman's noose, er, put on the REACH authorization list, have been announced by the European Commission.  These "substances of very high concern" had been put onto a "candidate list" for comment, but as of today have been moved to the authorisation list itself, which is known as Annex XIV under Europe's REACH regulation. 

The six substances are:

• musk xylene
• MDA
• HBCDD
• DEHP
• BBP
• DBP

[Okay, I realize the short forms and initials won't be recognizable to some; you can see full names in the press release here.]

Now that these six are in Annex XIV they "cannot be placed on the market or used unless authorisation has been granted for a specific use."  Obviously they are already on the market so for each substance there is a "sunset date" after which they can no longer be manufactured or imported in Europe unless an authorization application is filed and accepted.  Sunset dates for these six chemicals are in 2014 or 2015.  So manufacturers need to be developing an authorization application, which must include substantial health and safety data, information on the uses, a socioeconomic analysis to demonstrate why the societal benefit for keeping them on the market, and the specific uses that will be supported.  Only those uses that are deemed to be of sufficient need and can be controlled will be approved for continued use, and then only for a specified time frame (e.g., 5 years) to allow development of alternatives.

And the company applying for the authorization is responsible for identifying an alternative or providing a plan for how they will develop one.  Of course, competing companies may already have alternatives that can easily slip into the void but that couldn't compete with the usually lower cost, but more hazardous, chemical that already dominated market share.

Keep in mind that these are just the first six chemicals to be put on Annex XIV.  There are many more already on the candidate list, with more to be added periodically.  Manufacturers of chemicals that are "substances of very high concern" should be working to either find alternatives or to argue why they should not be put on the authorization (i.e., to be banned) list.

Chemical Companies Register Thousands of Chemicals Under REACH - Now What?

The first 25,000 registration dossiers under REACH - for nearly 3,400 chemicals - were submitted to the European Chemicals Agency (ECHA) by the November 30, 2010 deadline.  Over 3.1 million classification and labeling notifications were received by the January 3, 2011 deadline.  The next tier registration deadline is not until June of 2013.  So now what?  A lot, so while many companies are feeling a sense of relief from meeting the deadlines they should not get too comfortable.

ECHA has a statutory requirement to review a minimum of 5% of the REACH registration dossiers submitted.  Sure, that's only about 1,250 dossiers, right?  Not so fast.  The 5% figure is a minimum.  ECHA could conceivably review 100% of the dossiers if they wanted to, assuming they could come up with the time and manpower resources (which is highly unlikely).  But many of the dossiers submitted contain "Annex IX and X testing proposals."  For those less familiar with REACH there are a series of Annexes that list the various test endpoints for which data must be provided.  The endpoints listed in Annexes VII and VIII were required to be provided, including testing if necessary, along with the registration.  But for Annexes IX and X, which include most of the longer-term, animal-intensive, test methods, registrants were required only to provide results they already had in-house but were banned from conducting any additional animal testing prior to submission.  Instead they provided "testing proposals" indicating what additional Annex IX and X tests they planned to conduct.

What all this means is that ECHA must review all of the dossiers that include testing proposals in order to determine whether or not the proposed studies will actually inform their decision-making process.  They will not allow animal testing if they think it will not change their decision.  They also will insist that any testing be conducted in collaboration with other registrants in order to minimize animal testing.  To do this they will publish a list of substances proposing testing and ask for anyone with available data to come forward.  These third parties then have 45 days to provide valid data to address the endpoint, and assuming it fulfills the data requirement the registrants will have to pay the data holder for use of the existing data.

ECHA has until December of 2012 to respond to testing proposals received by the first registration deadline. Companies then will have a set period of time in which they must conduct the studies and update their registration dossier.  The time frames will vary depending on the type and amount of testing since some studies could take 2 to 3 years to conduct.

The Final REACH Registration Numbers Are In - ECHA Reports Nearly 25,000 Registrations

Yesterday (November 30, 2010) marked the first deadline for registration of chemicals under the European Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.  And the European Chemicals Agency (ECHA) has quickly issued a press release summarizing the results - "ECHA had received 24,675 registration dossiers, submitted for nearly 3,400 phase-in substances."

While companies have had almost 3 years to prepare dossiers on their chemicals, most of that time was spent working with other companies in consortia and navigating the new idea of SIEFs (Substance Information Exchange Forums).  According to ECHA:

T"the numbers of registrations increased steadily throughout the year, but from September 2010, the trend changed. Numbers soared dramatically - incoming registrations in a single month totalled four times the number of dossiers previously registered. The increase became more gradual again in October – an increase of 7% percent - with statistics increasing again over the last month."



About 12% of dossiers were submitted by "Lead Registrants," i.e., the company who volunteered to present the data developed by consortia and other groups of companies manufacturing or importing the same chemicals.  About 82% of the submissions were from "Member Registrants," those companies who contributed to consortium development of the dossier submitted by the Lead.  Only 6% of the submissions were from individual registrants, i.e., single companies that provided all the data for a chemical.


Nearly a quarter of submissions came from one country - Germany - which shouldn't be too surprising given the number of larger firms located there.  Most of the submissions (86%) came from large companies, with medium, small, and micro sized companies accounting for only 9%, 4%, and 1% of the submissions, respectively.


Only 580 of the nearly 25,000 dossiers contained testing proposals, for a total of 1,548 proposed tests.  ECHA will review all of these and any test proposed on animals will be subject to public consultation.



More details can be found in the ECHA press memo and registration statistics.