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?)

Wednesday, October 15, 2014

Will Polymers Be Regulated Under REACH?

The European Commission is reviewing whether polymer materials should be managed under the REACH regulation. Polymer uses include everything from industrial sealants, sanitary cloths, tires, rubber duckies, diapers, and credit cards.

Industry hopes EU authorities will tread carefully toward further tightening of requirements for polymers; their hope is that no additional regulatory burdens be placed on industry.

“The commission previously agreed to exempt polymers but reserved the right to revisit this issue at a later date,” said Jim McGraw, head of the International Institute of Synthetic Rubber Producers, quoted in Rubber News. “This matter is now under debate."

The EC is expected to "reach" a decision, as it were, in early 2015.

Jim McGraw, interestingly, is expected to retire around the same time.

Coincidence? 

Probably, yes. 

But you couldn't blame him if it wasn't.


Wednesday, October 8, 2014

ECHA Biocidal Products Committee Adopts 10 Opinions

In ECHA news..

The Biocidal Products Committee adopted 10 opinions last week.

The Biocidal Products Committee (BPC) met for the seventh time from 30 September to 3 October 2014. The adopted opinions concern, and support the approval of the following active substances and their product-types (PTs):
  1. glutaraldehyde for PTs 2, 3, 4, 6, 11 and 12
  2. clothianidin for PT 18
  3. MIT for PT 13
  4. MBM for PTs 6 and 13
Fields of application include active substances for use in biocidal products used as:
  1. disinfectants
  2. preservatives 
  3. insecticides
More information is here, from ECHA.

Background

A biocide is a chemical substance or microorganism which can deter, render harmless, or exert a controlling effect on any harmful organism by chemical or biological means. Biocides are commonly used in medicine, agriculture, forestry, and industry. Biocidal substances and products are also employed as anti-fouling agents or disinfectants under other circumstances: chlorine, for example, is used as a short-life biocide in industrial water treatment but as a disinfectant in swimming pools. Many biocides are synthetic, but a class of natural biocides, derived from, e.g., bacteria and plants.

The Biocidal Products Committee prepares the opinions of the European Chemicals Agency (ECHA) related to several processes under the Biocidal Products Regulation. Each EU Member State is entitled to appoint one member to the BPC for a renewable term of three years.

In relation to applications for the approval of new active substances, companies have to apply for approval of an active substance by submitting a dossier. After a validation check, the evaluating competent authority carries out an evaluation within one year. The result of the evaluation is forwarded to the BPC, which prepares an opinion within 270 days. The opinion serves as a basis for decision-making by the European Commission and the Member States. The approval of an active substance is granted for a defined number of years, not exceeding 10 years.

Substances which were on the market before May 14, 2000 and are evaluated under the biocides review programme in an analogous manner to new active substances, are referred to as existing active substances.

During the approval process of an active substance, the evaluating competent authority may conclude that the active substance meets the criteria for substitution of Article 10(1) of the BPR and is therefore a potential candidate for substitution. The objective of this provision is to identify substances of particular concern to public health or the environment and to make sure that these substances are phased-out and replaced by more suitable alternatives over time. The criteria for substitution are based on the intrinsic hazardous properties in combination with the use and include, for example, if the substance meets at least one of the exclusion criteria listed in the BPR or if the substance is a respiratory sensitiser.

For substances that are identified by the evaluating competent authority as a potential candidate for substitution, ECHA will initiate a public consultation to allow interested third parties to submit relevant information, including information on available substitutes. Subsequently, in the preparation of its opinion, the BPC reviews the proposed identification of the active substance as a candidate for substitution. Active substances which are candidates for substitution will not be approved for more than seven years, even in the case of renewal. If the active substance meets one or more exclusion criteria, it will only be approved for five years. When an active substance is identified as a candidate for substitution, products containing that active substance will have to be subject to a comparative assessment at the time of authorisation and will only be authorised if there are no better alternatives.

Monday, September 29, 2014

Taiwan Implements REACH Regulation

Taiwan has revised their Toxic Chemical Substance Control Act (TCSCA). The Act will adopt an REACH-like registration scheme which requires manufacturers and importers to register their new and existing chemical substances prior to entering Taiwan’s market.

New requirements will come into force on Dec. 11, 2014. Several new rules have been issued in preparation for the implementation of Taiwan's latest chemical registration system.

Taiwan’s new chemical registration system will be set in motion on Dec.11, 2014. Completing a national existing chemical substance inventory (ECSI) is a prerequisite for Taiwan new chemical substance notification.

Substances not listed in the ECSI are regarded as new chemical substances subject to new chemical substance registration under the revised TCSCA, except where certain exemption conditions are met.
Exemption Conditions: 
  1. Polymer applicable to the 2 % Rule
  2. Polymer of low concern below 1 t/y
  3. For scientific research below 1 t/y
  4. Incidental reaction products or impurities without intended commercial purpose
  5. Inseparable intermediates
  6. Mixture (not applicable to chemical substances in the mixture containing new chemical substance)
  7. Articles (not applicable if the substances contained in the article will be intentionally released during normal use)
  8. Wastes
  9. A substance or a polymer occurred in nature
  10. Chemical substances accompanied in machines and equipment for test‐run purpose
  11. Chemical substances under customs supervision
  12. Chemical substances for national defense purpose 
The new chemical substance should be registered 90 days before manufacture or importation. Based on the tonnage band and usage information, three registration types will be adopted, including standard registration, simplified registration, and low-volume registration.

Find out more: here, at ChemLinked.


Wednesday, August 27, 2014

9 New Substances Added To REACH Authorization List

Nine new substances have been added to the REACH regulation Authorisation List.

On August 19th, the European Commission added nine (9) new substances on the Authorisation List (Annex XIV) of the REACH Regulation. These substances of very high concern had been prioritized by ECHA in January 2013 and are used, for instance, as solvents, anti-corrosion or curing agents.

The latest application dates range from February 2016 to July 2017. The Authorisation List currently contains a total of 31 substances.

Here is a link to official ECHA Authorisation List.

The Authorisation List is...

The European Chemical Agency (ECHA) has published the REACH Authorization List, in an effort to tighten the use of Substances of Very High Concern(SVHC)1. The list is an official recommendation from the ECHA to the European Commission.The list is also regularly updated and expanded, and currently comprises a total of 155 SVHC.

To sell or use these substances, manufacturers, importers and retailers in the European Union (EU) must apply for authorization from the ECHA. The applicant is to submit a chemical safety report on the risks entailed by the substance, as well as an analysis of possible alternative substances or technologies including present and future research and development processes.