Tuesday, March 31, 2015

Prepare to Comment

Registrants: prepare to comment on substance evaluation draft decisions. Soon, the European Chemicals Agency (ECHA) will send requests for further information about substances evaluated under the Community rolling action plan in 2014 to registrants for comments.

In 2014, Member States were evaluating 51 registered substances under the substance evaluation process. If further information is needed to assess the safety of the substance, they have prepared a draft decision. (The deadline for submitting a draft decision to ECHA was March 26, 2015. If you're late, contact ECHA immediately, they are often willing to work with you.)

ECHA has now received draft decisions on 40 substances. Registrants are preparing to give consolidated comments on the draft decisions addressed to them.

How to proceed


ECHA plans to send out the draft decisions to the relevant registrants May 4th through 8th. Registrants of these substances will have 30 days to consider and submit comments. A notification letter will specify comment deadline. If during those dates you feel you should have received a letter and did not, immediately contact ECHA with your query.

Registrants are encouraged to coordinate and speak with one voice; recommendation is that one representative, the Registrants Contact Point, should send consolidated comments on the draft decisions on behalf of all registrants.

So in the meantime, wait for your May letter. But have your comments ready.

Friday, February 27, 2015

Update: Information Requirements For Reproductive Toxicity

REACH Update: There are new information requirements for reproductive toxicity.

As of mid-March 2015 the REACH annexes VIII, IX and X have been amended with the inclusion of the Extended One-Generation Reproductive Toxicity Study (EOGRTS, EU B.56, OECD TG 443).

EOGRTS will now be the information requirement for reproductive toxicity in REACH instead of the old way, the two-generation reproductive toxicity study (EU B.35, OECD TG 416).

The updated annexes will enter into force March 13, 2015. ECHA is updating its guidance on reproductive toxicity to reflect the regulatory changes and aims to finalize it by July 2015. A draft is already available on ECHA's website.

Draft guidance: http://echa.europa.eu/documents/10162/13643/ir_csa_r7a_r76_reprotox_draft_en.pdf

Find out more here.

Thursday, February 5, 2015

How Are Substances Evaluated Under REACH?

Many ask, how does substance evaluation work under REACH regulation?

How it works is this:  Member States evaluate certain substances to clarify whether their use poses a risk to human health or the environment. The evaluation may conclude that risks are sufficiently under control via measures already in place. If current controls are not sufficient, the evaluation may lead to the proposal of EU-wide risk management measures such as:
  1. restrictions
  2. identification of substances of very high concern (SVHC)
  3. harmonized classification 
  4. other actions outside the scope of REACH

How are substances selected for evaluation?


In cooperation with the Member States, ECHA defines risk-based criteria and then selects the substances that are to be evaluated.

The selected substances are listed by ECHA in the community rolling action plan (CoRAP) following the opinion of the Member State Committee. More on CoRAP and its list of substances here.

An evaluating Member State will be designated for each substance on the final CoRAP.

And yes, we all wish they would change that acronym. It's not right.

The initial reason for selecting a substance for the CoRAP is not limiting the scope of the evaluation. During the evaluation, the Member State may identify other concerns that need clarification in order to conclude whether a substance is of concern or not. However, the Member State may focus the evaluation more upon certain aspects of the substance.

The substance evaluation process assesses all registration dossiers from all registrants specific to the same substance, i.e. in order to take into account the combined exposure. Other available sources of information are also considered.

The evaluating Member State has 12 months from the publication of the CoRAP to decide whether it needs to request further information from the registrants to clarify the concern.

And beyond


This request might go beyond the standard information requirements of REACH (Annexes VII to X) and may pertain to the intrinsic properties of the substance or its exposure. For example, registrants may need to provide studies on mode of action or monitoring of concentration levels in organisms or the environment, and the view that further information is needed is shared with all the other Member States and ECHA to achieve a general agreement. ECHA decides to request further information if necessary.

The objective is to request further information from the registrants of the substance to verify the suspected concern, if necessary.

For more specifics, see the ECHA substance evaluation fact sheet.

Friday, January 30, 2015

New CLP FAQs

The national CLP help desks, ECHA and the Commission have agreed on five new CLP FAQs which have recently been published on ECHA's website.

These FAQs touch upon the following subjects:
  1. harmonized classification and labeling requirements
  2. mixture classification
  3. CLP pictogram requirements
  4. the classification, labeling and packaging requirements for biocidal products
The new FAQs use the unique IDs 1049, 1050, 1051, 1052, and 1053.

Find the new FAQs here.


Tuesday, January 6, 2015

New Version of PIC Regulation Reporting Tool

More material disclosure to manage in substance management: the PIC Regulation. During Q1 each year, European companies must report the specific quantities of chemicals subject to the PIC Regulation that have been exported/imported during the previous calendar year.

During the Q1 reporting season, companies must provide not just quantity information but also details on any and all non-EU based companies with which they traded PIC-regulated chemicals.

The deadline to submit the above information is 31st of March. ECHA would like exporters and importers to report sooner rather than later.

Technology update: ePIC 1.1


With the release of ePIC 1.1 on 8 January 2015, industry users will be able to generate and submit reports to their relevant Designated National Authorities. In the new version of ePIC, for most users a draft version of the reports is automatically generated and pre-filled by ePIC ("to the extent possible," says ECHA) with data available in the system.

Once the reports have been finalized, they can be sent to the Designated National Authorities for aggregation on country level.

The ePIC system will be down from January 7th at 09:00 (EET) until January 8th at 09:00 (EET).

PIC Guidance can be found here. Tools for managing compliance exist via third party vendors.

For more on the PIC regulation, please see ECHA's page.

Friday, December 19, 2014

REACH Updates Candidate List Dec. 17

The REACH Candidate list now includes six new SVHCs on the Candidate List. ECHA updated the list based on agreement of the Member State Committee, and updated one existing entry to address an additional reason for inclusion.

bis(2-ethylhexyl) phthalate (DEHP) meets the criteria for identification as an SVHC due to its endocrine disrupting properties which in turn cause probable serious effects to the environment. DEHP is already included in the Candidate List for its toxic reproduction properties, so DEHP was simply updated.

The five newly listed substances are:

  • Cadmium fluoride
  • Cadmium sulphate
  • 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)
  • 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)
  • 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)
The total number of chemicals on the Candidate List is 161.

For the ECHA official list, visit the ECHA page.

To download a third party (some companies, concerned about privacy, prefer this) there is a complete, downloadable REACH Candidate list on the Actio website. You can always Google "Actio Blog" and find blog posts under the subject "REACH." In this case visit blog post from December 17th 2014.


Thursday, December 11, 2014

Read-Across Approaches for Nanoparticles

Read-across and category approaches are used to predict properties of substances for which there is not enough experimental data. This is a pragmatic way to bridge data gaps to characterise the hazards of nanomaterials. Or is it? Here's a recent interview with two insiders about recent developments in this field.

Question: How do read-across and category approaches relate to this development? Why are they important?

Robert Landsiedel, Research Manager & Toxocologist, BASF, Germany: 

"Nanomaterials are typically embedded in a product or used on its surface. To become toxicologically relevant, they need to be dispersed or released from the product.

It is neither possible to test each different nanomaterial exposure for all of its toxicological properties, nor do we have a full understanding of how the material properties of nanomaterials may cause adverse health outcomes. As such, classical QSAR computer modelling approaches are not yet capable of providing a sufficient grouping concept.

We propose to use a multi-perspective approach: rather than taking 'the long shot' from material properties to adverse outcomes, we should also look at the steps in between: the life-cycle of the nanomaterial; the exposure; uptake; distribution; biophysical interactions; as well as cellular and organ responses, to understand which together with regard to their adverse health effects."


Dr. Wim de Jong, ECHA:

"In view of the expected development of new or modified nanomaterials, there is a need for read-across and grouping. To evaluate nanoparticle UV filters in sunscreens, first steps have been made in grouping and read across. These approaches were used to evaluate the same nanomaterial which was produced by different manufacturers. However, for unknown particles, we still have to apply other methods, such as high throughput screening, which gives more information on nanomaterials in a relatively short time. We can also evaluate modes of action or modes of activity. These are mainly used for prioritising nanomaterials, to find out the most toxic ones where we need more information.

We know that a nanomaterial behaves differently in terms of reactivity, because it is made specifically to be, for example, a more efficient catalytic agent or colouring agent. There is a reason why the nanomaterial has been produced. Why would you otherwise use a nanomaterial if the bulk material had the same properties?

There are limits to extrapolation, for example, based on information about the toxicity of the chemical structure. Ultimately, however, you also need nano-specific information. Characterisation is important to identify the nanomaterial.

However, to make a decision on grouping, a list of characteristics is not enough. You also need practical information on different assays. It is still difficult to come to a grouping which would be based on physico-chemical parameters on its own."

Check out the full interview here:

Interview

Background: The grouping of substances and read-across offer a possibility for adaptation of the standard information requirements of the REACH Regulation, with the conditions for using grouping and read-across approaches to fulfil information requirements set in Annex XI, 1.5. If the read-across approach is adequate, unnecessary testing could be avoided. A read-across approach can also support a conclusion for a REACH endpoint using a weight-of-evidence approach.

More on Read-Across here.