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Draft guidance: http://echa.europa.eu/documents/10162/13643/ir_csa_r7a_r76_reprotox_draft_en.pdf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

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.

Tuesday, October 28, 2014

Clarification: Cosmetics Disclosures and REACH

In Europe now, cosmetic products are prohibited from placement on the market where:
  1. a final formulation
  2. ingredients in a final formulation, or 
  3. a finished product
have been subject to animal testing. This is per the new Cosmetics Regulation (Regulation (EC) No 1223/2009).
Animal Stewardship

However (!) ... those same chemical ingredients may also need to be registered under REACH. This has created some uncertainty about whether testing on animals can take place in order to comply with REACH, or whether it should not, in order to comply with the Cosmetics Regulation.

The European Commission, in cooperation with ECHA, has now clarified the REACH information requirements as follows:
  • Registrants of substances that are exclusively used in cosmetics may not perform animal testing to meet the information requirements of the REACH human health endpoints, with the exception of tests that are done to assess the risks to workers exposed to the substance
  • Workers in this context, refers to those involved in the production or handling of chemicals on an industrial site, not professional users using cosmetic products as part of their business (e.g. hairdressers)
  • Registrants of substances that are used for a number of purposes, and not solely in cosmetics, are permitted to perform animal testing, as a last resort, for all human health endpoints
  • Registrants are permitted to perform animal testing, as a last resort, for all environmental endpoints
  • Therefore, the testing and marketing bans in the Cosmetics Regulation do not apply to testing required for environmental endpoints, exposure of workers and non-cosmetic uses of substances under REACH
  • Registrants of substances registered exclusively for cosmetic use will still have to provide the required information under REACH wherever possible, by using alternatives to animal testing (such as computer modelling, read-across, weight of evidence etc.)
Substances used in cosmetic products may need to be registered under REACH but, under certain circumstances registrants may not have to carry out new tests on animals. Answers to questions on the interface between REACH and the Cosmetics Regulation are available on ECHA's website.

Wednesday, October 22, 2014

REACH Substance Evaluation -- Ask The Experts

Quality control of REACH submissions, such as testing proposal examinations and compliance checks, are evaluation activities done by ECHA. But substance evaluation is checked by Member States.

In substance evaluation, the focus is on the substance itself. The focus is not on individual dossiers.

The point of a substance evaluation is to find out if more information is needed in order to understand potential risks of a substance to human health and the environment.

Ask the experts

Check out quotes from Member State representatives from Germany and France. Words are somewhat revealing about their experiences of evaluating substances.

"If a substance is listed in the CoRAP and Germany is chosen as the evaluating Member State, we have to clarify whether or not the uses of that substance are a risk to human health or the environment," says Dr Mark Schwägler from the German Federal Institute for Occupational Safety and Health (BAuA). (The evaluation is based on data available in REACH registrations and other sources.)

In France, substance evaluations are carried out by the French Agency for Food, Environmental and Occupational Health & Safety (Anses). For each substance, an expert team is created at Anses to carry out the assessment. "The expert team consists of toxicologists, ecotoxicologists and chemists. When needed, external scientific experts may intervene with particular parts of the evaluation, subject to Anses's conflicts of interest rules," explains Ms Corinne Belveze from the Ministry of Ecology, Sustainable Development and Energy.

"During the process, Anses sends requests to industry for clarification, and organises informal meetings to discuss specific endpoints or sections of the dossiers," Ms Belveze explains.

According to Dr Schwägler, BAuA has a similar approach. "Until now, in most cases at least one face-to-face meeting has been organised," he says. "These meetings help us to better understand the information that the registrants have provided. They also help the registrants to better understand the substance evaluation procedure."

The next CoRAP update covering 2015-2017 will be submitted to the Member State Committee for its opinion in October. The draft list will be published on ECHA's website by the end of October. The adoption of the list is expected to take place in March 2015.

For more on this subject and this interview, visit this page.

What is CoRAP?

The annually updated Community rolling action plan (CoRAP) lists the substances that are being prioritised for substance evaluation. The substances are selected by the Member States and ECHA.

In American-ese, far as chemicals go, all this means cut the CoRAP.

(Who can resist these things?)