Tuesday, June 30, 2015

ECHA and PETA Compare Policy on Animal Testing

The People for the Ethical Treatment of Animals, PETA, has presented a petition to the European Chemicals Agency (ECHA) about avoiding testing on animals.

Doggie approved dialogue
In response, ECHA explains what it does to avoid unnecessary animal testing.

See the response here:
ECHA response to PETA

The Agency promotes many alternative test methods that companies can use to demonstrate the impact of chemicals they produce on human beings. ECHA is working with the Member States and the European Commission on how to best verify that tests on vertebrate animals have only been conducted as a last resort.

Tuesday, June 16, 2015

ECHA Updates Candidate List With 2 New Substances

Two new substances of very high concern (SVHCs) have been added to the REACH Candidate List. Right on schedule.

Happy chemical trails
This news came to us as an email alert from the European Chemicals Agency (ECHA) -- by the time we got it, the folks at Actio Blog had already run the article and that too was coming is an an alert! Fast! Have to give them credit for being on top. Now: their REACH Candidate List update blog post is in many ways easier to read than the ECHA announcement. ECHA has to tell you certain things, bloggers have to tell you relevant things.

So in that spirit -- here are the two (2) newly listed chemicals on the REACH Candidate list:
  • 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ? 0.3% of dihexyl phthalate (EC No. 201-559-5)
  • 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]
And this post by Actio is recommended reading for context and compliance obligations.

Find the ECHA page here: http://echa.europa.eu/candidate-list-table

The Candidate list is now 163 substances.

Friday, June 12, 2015

REACH Authorization Now Requires Summary Tables

Companies applying for authorization for their substances under REACH regulation need to fill in a summary table of their risk management measures and operational conditions.

The table is now a mandatory document to be filled in and submitted as a part of the application for "authorisation dossier."

This table is essentially a summary document. It's not as complicated as it sounds. A table summarizes the representative and relevant risk management measures (RMMs) and operational conditions (OCs) set out in the exposure scenario (ES) from the chemical safety report (CSR). The idea is to facilitate the enforcement process and will provide authorization holders and downstream users with a simple format easily translatable into the local national language where the authorized use takes place. Essentially, it's a distillation of your e-SDS.

An e-SDS is an extended Safety Data Sheet which includes exposure scenarios, so downstream users of a product know what uses have been safety tested. Example: a spray can may not have been tested for direct inhalation, so that would be out of scope of uses covered by an SDS! More about exposure scenarios and Safety Data Sheets here: the REACH extended SDS.

The summary needs to be clear, unambiguous and presented in a tabulated manner, describing the RMMs/OCs for safe use of the substance. The applicant will compile the information required for the table from the full set of conditions which should be described in the exposure scenarios included in the CSR.

ECHA emphasizes there are no additional information requirements due to this new document.

See summary table here to get started: http://echa.europa.eu/applying-for-authorisation/preparing-applications-for-authorisation

Tuesday, May 26, 2015

Nicotine: New Dossier for Classification and Labeling

Five dossiers for harmonized classification and labeling (CLH) have been submitted to the European Chemicals Agency (ECHA). CLH is under the classification, labeling and packaging of substances and mixtures (CLP) regulatory umbrella. *See below for background and context.

Nicotine is among the five new submissions. Specifically, the proposal is for the relevant LD50 (dose descriptor) to be used to derive acute toxic estimate (ATE).

Range: Minimum purity > 95%; identity impurities is "confidential" (smokers beware)

Submitted by: Netherlands.

Five dossiers in total for harmonised classification and labelling were submitted for the following substances:

  1. nicotine (ISO) (EC 200-193-3) (CAS 54-11-5) The isomer, used in cigarettes and as pesticide (toxic in direct intake to humans, birds and bees) 
  2. propane-1,2-diol (EC 200-338-0) Used as a solvent, emulsifying agent, and antifreeze 
  3. spiroxamine (ISO) (CAS 118134-30-8) A fungicide used in producing cereals and certain fruits
  4. pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate (EC 205-391-3) Largely a chelating agent, used in cosmetics among others 
  5. pyroxsulam (ISO) (CAS 422556-08-9) Herbicide 


Those are the newest. See entire list of proposals to ECHA here.

About submitting a CLH

Member State competent authorities may propose a new harmonized classification and labeling (CLH), or a revision of an existing CLH, for any substance that is under the scope of the CLP Regulation (Article 37(1) ). Manufacturers, importers and downstream users may propose CLH for those substances which are not active substances in biocidal products or plant protection products, and provided that there is no existing entry in Part 3 of Annex VI to the CLP Regulation for such a substance in relation to the hazard class or differentiation covered by the proposal (Article 37(2)). Manufacturers, importers and downstream users are required to have a REACH-IT account to submit a CLH intention or dossier.

*Background / context
Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on classification, labeling and packaging of substances and mixtures (the CLP Regulation) entered into force on January 20, 2009. Title V of the CLP Regulation contains provisions for submission of proposals for harmonised classification & labelling. The CLP Regulation specifies that Member State Competent Authorities (MSCAs) as well as manufacturers, importers or downstream users may submit proposals for harmonised classification and labelling (CLH proposals) of substances to the European Chemicals Agency (ECHA) (Article 37, CLP).

** Definitions
For each health effect and each relevant exposure pattern, a DNEL needs to be established. There are levels of exposure to any substance "above which humans should not be exposed." This level of exposure is known as the Derived No-Effect Level (DNEL).  Since dose descriptors are obtained from experimental data, the assessment factor is required to allow for extrapolation to real human exposure situations. The DNELs are calculated by dividing the value of the health effect dose descriptor by an assessment factor. Dose descriptors are determined in the toxicological studies on the hazards of the substance and are usually expressed as NOAEL, NOAEC, LD50, LC508, etc (more here). The term “dose descriptor” is used to designate the exposure level (dose or concentration) that corresponds to a quantified level of risk of a health effect in a specific study.

New Occupational Hygiene Jobs in REACH

The ECHA Secretariat foresees a peak workload on evaluating applications for authorization from late 2015 through 2016. REACH committees are seeking up to five (5) qualified candidates to help with the job. Interested? Occupational hygiene professionals are encouraged to apply.

How to apply
"Expressions of interest" (pleasant term, don't you think?) from candidates should be submitted via a web form by June 4, 2015 at midnight Helsinki time. Only properly completed online web forms will be considered. Online web forms are here.

Who's asking?
The Committee for Risk Assessment (RAC) prepares opinions of the European Chemicals Agency (ECHA) related to the hazards and risks of substances to human health and the environment, while the Committee for Socio-economic Analysis (SEAC) prepares opinions of ECHA related to the socio-economic impact of possible legislative actions on chemicals. In particular, RAC and SEAC are tasked to prepare and adopt opinions on Applications for Authorisation as set out in Title VII of Regulation (EC) No 1907/2006 (REACH Regulation). The opinions of RAC and SEAC form the basis for the European Commission to decide on the authorization of the uses applied for by Industry.

The members of the two Committees are highly qualified, specialized and independent scientific experts in different areas relating to the risks of chemicals to human health and the environment and to socio-economic analysis. They are appointed in their personal capacity as independent experts. In addition to the members nominated by Member States, RAC and SEAC may co-opt a maximum of five additional members chosen on the basis of their specific competences.

This call for expression of interest has been made in order to identify potential candidates and to prepare a proposal for appointment as co-opted members for approval by RAC and SEAC.

General Requirements:
  1. Ability to work efficiently in a multidisciplinary expert team
  2. Aptitude for negotiation and consensus building on complex matters
  3. Ability to keep timetables under pressure
  4. Very good skills in written and spoken English
  5. Loads of certification and schooling helpful
General Assets:
  1. Experience with Committee work at national or international level
  2. Preferably you have worked in the public service of an EU Member State/ EEA-EFTA country, or in academia.
Visit the full job announcement here.

Candidates will be reviewed based on their expression of interest and the attached resume, and may be invited by the Agency to a phone interview or interview at Agency premises. Candidates considered for interviews will be asked to submit a declaration of interest form, in line with section 3 above. Appointment of successful candidates as co-opted member will be agreed by RAC and SEAC.

Member States will be invited to consider nominating candidates to regular membership of RAC/SEAC (i.e. without co-option) from the list of suitable candidates of this call.

Monday, April 27, 2015

Next REACH Deadline Cometh

The key upcoming deadline concerns substances manufactured or imported into the EU in relatively low volumes, only 1 to 100 tonnes per year.The European Chemicals Agency (ECHA) encourages businesses to start preparing now. Below please find a checklist that may help with preparation programs.

Low volumes represent a big compliance challenge because many small to mid-sized businesses either ship chemicals in that range or use chemicals in that range in their products.

To find out exactly what substances you might be responsible for in your products, mixtures and articles, most companies are now using product ingredient tracking software. Tracking software culls a Bill of Materials and queries suppliers for substance-level data. Over time, the data is collected in an organized fashion in a rational database. This means reports can be run and meaningful information and compliance docs can be extracted easily and quickly from the data. Actio Corporation has put together a checklist for what to look for in REACH compliance software. Included is WEEE and RoHS regulations -- because the process for supplier data collection is similar can can be cross-purposed for all. Complimentary download, but you are asked to enter your name and email.


You likely have upcoming registration obligations under REACH if your business:
  1.     Manufactures chemicals or imports them from outside the EU above one (1) tonne per year
  2.     Manufactures or imports any product (mixture, article), as it may contain substances that need to be registered individually
ECHA published a notice recently reminding companies to start preparing for the upcoming deadline now. More info is available on the ECHA website.

Wednesday, April 22, 2015

Check Your Pre-Natal Developmental Toxicity

Registrants of the highest volume chemicals are invited to check that the information on pre-natal developmental toxicity (PNDT) is adequately addressed — while avoiding unnecessary animal testing. For more on animal testing, read our previous post, How To Avoid Animal Testing Under REACH and also Animal Testing On Decline.

Who should pay closest attention? Highest volume registrants. That means entities who are registering over 1,000 tonnes of chemicals per year.

You can check your reporting by reviewing core information on PNDT studies here:
  1. Annex X, standard information requirements for substances manufactured or imported in quantities of 1,000 tonnes or more (more here)
  2. Annex IX, standard information requirements for substances manufactured or imported in quantities of 100 tonnes or more (more here)
  3. The relevant guidance (here)
ECHA has published information on the adaptation rules in Chapter R7a of the Guidance on Information Requirements and Chemical Safety Assessment (more here).

Note that "endpoint specific" guidance is being updated. Expect publication as soon as July 2015.