ECHA Starts REACH 2013 Campaign to Urge Chemical Companies to Act Now!

The European Chemicals Agency (ECHA) has launched a campaign to encourage chemical companies to "Act Now!" to meet their planned registration obligations for the second round of REACH.  The next registration deadline - for substances manufactured or imported at tonnages at or above 100 tonnes per year - is May 31 2013. 

ECHA's goal is to get companies thinking now about how they will fulfill the data requirements and interact with other members of SIEFs, including any data gathering and compensation to existing data holders.  Preparing for and submitting registrations earlier rather than all at the last minute is good for both ECHA and the registering companies.

To do this, ECHA has started a program called REACH 2013 - Act Now!

The web page provides "key information to support you in your preparations for the 2013 registration."  It includes "links to all the steps of the registration process: from the formation of the Substance Information Exchange Fora (SIEFs) to data sharing, dossier preparation and online submission."


According to the site, potential registrants need to be getting organized to do:

1. Substance identification, hazard information, data-sharing
1. Substance identification and sameness of substance: Confirm with the other pre-registrants that you have the same substance;
2. Hazard information: Collect all data available on the intrinsic properties of the substance to be registered;
3. Data sharing: As part of a joint registration, gather and share existing information, consider alternatives to testing and answer any information request from within your SIEF;
2. Chemical safety assessment: Carry out a chemical safety assessment in order to produce a chemical safety report based on the hazard information collected and knowledge on the uses.

 More information can be found on the ECHA web site.

ACC's Chemical Prioritization Tool - EDFs Analysis is One Thumb Up, One Thumb Down

Last week I reported on an analysis of the EPA's proposed chemical prioritization tool done by Richard Denison of the Environmental Defense Fund (EDF).  Today I report on Denison's follow up analysis on the counter-proposal prioritization scheme released by the American Chemistry Council the day prior to EPA's webinar.  I'll start with Denison's conclusion:

"While ACC’s tool has some serious flaws and is not something that EPA has the authority or resources to utilize under current TSCA, ACC has put forth a serious proposal for prioritization that should help to raise the level of debate over this critical issue in TSCA reform."

As suggested, Denison notes that the ACC proposal offers some "refreshing elements and acknowledgements."  He describes it as "substantive and specific" and is "welcome in several ways."  He goes on to summarize some of the areas he feels are constructive (see his full blog entry).  Notwithstanding these kudos, however, Denison does suggest that ACC's proposal seems better suited for a full TSCA Reform element and that implementation of the ACC plan is not likely to be possible under the current (and likely future) resource and funding constraints limiting EPA's activities.


Denison finds that there are "a number of quite problematic aspects of ACC's proposal," including:

• Overly rigid rules applied in lockstep: Denison finds ACC's proposed "equal basis" rule to be "sleight of hand" that will "rule out any types of information that may indicate a hazard or exposure of high concern unless it has been measured across basically all chemicals subject to prioritization."  The "high hazard and high exposure" rule would allow prioritization of only those chemicals "for which high hazard and high exposure can be demonstrated;" a proposal that Denison finds to be "simply shortsighted." He also critiques ACC's "persistent and bioaccumulative" rule, which he finds includes "extremely narrow definitions of P and B" that would avoid prioritizing chemicals that would in fact be either P or B (or both).
• Consistent use of the least conservative classification values: Denison points out that the ACC proposal relies on the classification criteria developed under GHS, which he generally supports.  However, he does quibble with what he feels are two limitations - GHS doesn't include every endpoint of concern and ACC chooses the least conservative values instead of adhering to GHS' cutoff values faithfully.  A choice where Denison feels "ACC fails badly."
• Over-relying on limited exposure information and discounting evidence of hazard: Denison notes that ACC's tool lumps together its health and environmental hazard rankings into a single score while combining scores for its three exposure elements, which "means that a chemical that harms both people and other organisms only gets counted once, while a chemical that is low-volume and used only as an intermediate and is not P or B gets credit for being of low concern for all three attributes."  The way the tool handles hazard vs exposure rankings also is likely to skew the results such as to avoid prioritization for chemicals that could indeed be problematic.

Despite these significant critiques, Denison feels that the ACC prioritization tool is a good effort and a basis for informed debate as the process moves forward.  Combined with his previous critique of the EPA prioritization proposal, there clearly is a path forward for enhancing chemical regulation and improving protection of the environment and human health.  But will it happen?

ECHA Risk Assessment Committee Adopts Seven Scientific Opinions

The following information comes from the ECHA web site:



The Committee for Risk Assessment (RAC) has adopted opinions on seven proposals for harmonised classification and labelling across Europe during its 17th meeting, held from 13-16 September 2011 in Helsinki.


Polyhexamethylene biguanide hydrochloride (PHMB)

RAC agreed with the proposal from France to classify PHMB as acutely toxic by the oral and inhalation route, damaging to the eye, as a skin sensitiser, as toxic to the respiratory tract after repeated exposure, suspected carcinogen and hazardous to the aquatic environment. The classification of this substance is not currently harmonised at EU level. PHMB is used as biocidal product (disinfectant).

Di-n-hexyl phthalate (DnHP)

RAC agreed with the proposal from France to classify DnHP for reproductive toxicity due to the potential for effects on unborn babies as well as on male fertility. The classification of this substance is not currently harmonised at EU level. DnHP is used in the manufacture of plastics.

Fenamiphos

RAC agreed with the proposal from the Netherlands to classify Fenamiphos as acutely toxic by the inhalation route and as an eye irritant. Fenamiphos already has a harmonised classification as acutely toxic by the oral and dermal route and as hazardous to the aquatic environment. RAC agreed with the proposal to replace the minimum classification for acute toxicity (indicate by an asterix) with the definite classification based on data. Further, RAC proposed an M-factor of 100 for chronic aquatic toxicity. Fenamiphos is used as a plant protection product.

Trichloromethylstannane (MMTC)

RAC agreed with the proposal from France to classify MMTC as toxic to reproduction. RAC did not agree with the proposal from France, to classify MMTC as mutagenic. The classification of this substance is not currently harmonised at EU level. MMTC is used as an industrial intermediate in the production of other organotin chemicals.

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (MMT (EHMA))

RAC agreed with the proposal from France to classify MMT(EHMA) as toxic to reproduction. RAC did not agree with the proposal from France, to classify MMT(EHMA) as mutagenic. The classification of this substance is not currently harmonised at EU level. MMT(EHMA) is used as a heat stabiliser in PVC.

Benzenamine, 2-chloro-6-nitro-3-phenoxy- (Aclonifen)

RAC agreed with the proposal from Germany to classify Aclonifen as a suspected carcinogen, as a skin sensitiser and as hazardous to the aquatic environment. Aclonifen already has a harmonised classification as hazardous to the aquatic environment. Aclonifen is used as a plant protection product (herbicide).

Perestane

RAC agreed with the proposal from the UK to classify Perestane as acutely toxic by the oral, dermal and inhalation routes, skin corrosive and as toxic to the eye after single exposure and to remove the classification for mutagenicity. Perestane already has a harmonised classification as acutely toxic by the oral, dermal and inhalation routes, skin corrosive and mutagenic. Perestane is used as a biocide (surface disinfectant).

More information can be found on the ECHA web site.

Denmark Proposes Restriction of Four Phthalates under REACH Chemical Regulation

Denmark has proposed to restrict "the placing on the market and use of certain articles containing four classified phthalates (DEHP, BBP, DBP and DIBP)."  These common phthalates are found in a variety of professional and consumer products, including PVC and in dispersions, paints and varnishes.  The primary rationale for these restrictions is that these "phthalates are all reported to affect reproductivity."

The Danish proposal is part of the REACH chemical regulation process, in which substances of very high concern can be proposed by Member States to be restricted from further use.  All interested parties (e.g., manufacturers and formulators, as well as other Competent Authorities) can comment on the proposal.  All comments will be "reviewed and taken into account by ECHA’s Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC)."  By September 2012 these Committees would provide their opinions, which will be the basis for final decisions on whether to restrict the substances from use in commerce

Comments are requested by December 16, 2011, though officially the 6-month public consultation being announced today ends in March 2012.

According to the ECHA news release:

The widespread use of phthalates is raising concern, regarding human exposure from consumer articles. The dossier addresses the combined exposure based on common effects seen with exposure to these phthalates.
In the report, Denmark suggests a ban for the placing on the market of articles intended for indoor use and articles that may come into direct contact with the skin or mucous membranes, containing one or more of these four phthalates in a concentration greater than 0.1 % by weight of any plasticised material.

More information can be found on the ECHA site.