News about Environment
and Toxicology

November 2015




Chemicals

News on REACH 2018 registrations

The European Chemicals Agency (ECHA) addressed the coming registration deadline in 2018 at the Nordic REACH Conference held in Copenhagen in September. Ms Catherine Cornu from ECHA’s Directorate of Registration informed that ECHA will assist especially the small and medium-sized companies in making the registration process more simple and in supporting companies with better guidance and tools.

Simplified registration for 20,000 substances
ECHA has established a specific home page REACH 2018 where industry can find advice, guidance and link to tools that can support in registering phase-in substances. Ms Cornu stressed that ECHA has taken a number of initiatives to simplify the registration process for the more than 20,000 individual substances that are expected before June 2018.

List of substances requiring a full data set
In 2016 ECHA will launch a new IT platform that allows co-registrants to submit their registration directly via the home page without having to install and use the IUCLID IT system. Furthermore, Ms Cornu emphasised that at low tonnages, substances between 1–10 tonnes per year, REACH requires only physical-chemical data for registration of substances that are non-hazardous to humans and the environment. ECHA will assist the registrants in identifying these by releasing a list of substances for which it is unlikely that the reduced information requirements can apply. ECHA expects to launch the list at the beginning of 2016.

For more information on REACH 2018, please contact

Jens Tørsløv
jet@dhigroup.com
Tel +45 4516 9022


Wanted: more robust applications for authorisations

One of the main topics at the Nordic REACH Conference in Copenhagen was learnings from previous REACH authorisations. In summary, the learnings from the first authorisations given under REACH is that more precise and less extensive and expensive applications dossiers are expected in the future. ECHA stressed that it would prefer applications that are shorter, more focused, robust and clear than what has been presented until now.

Benefits of downstream user applications
In the future, applications developed by downstream users covering only one or few uses may be the preferred solution. This may be the case where confidential business information (CBI) is an issue, or if the company prefers to have the freedom of sourcing from different suppliers. Other benefits are that the preparation time is shorter and it is easier to make a clear and focused application. Consequently, a longer authorisation period is likely.

For more information, please contact

Jens Tørsløv
jet@dhigroup.com
Tel +45 4516 9022


K-REACH: Korean chemicals legislation

Since the European Union adopted the REACH regulation in 2006 there has been a worldwide and increased focus on possible risks from chemicals. A main issue has been how legislation can ensure safe use of the many existing chemicals on the market. This concern has triggered development of new regulatory initiatives worldwide, including the Republic of Korea. A new Korean legislation on registration and evaluation of chemical substances (K-REACH) entered into force in January 2015.

K-REACH details not in place
Many of the regulatory instruments in K-REACH are similar to those in the European REACH legislation, however, the sharing of the responsibility between industry and the authorities seems different. Many details are not yet clarified and technical guidance is not yet available. Consequently, companies that export or intend to export chemicals or chemical mixtures into Korea face a challenge.

Only Representative responsibilities
As in Europe, it may be a solution to appoint a suitable Korean Only Representative (OR) who takes over the obligations to report, register and communicate with authorities and downstream users. It is the obligations of the Korean importer or the OR to make annual reporting, register substances that are subject to registration, communicate hazard information to the users, provide safety information, notify hazardous chemicals substances contained in mixtures as well as ensure compliance with authorised or restricted use of certain chemical substances.

Testing under K-REACH
There are uncertainties about how data from existing registrations can be used in Korea, i.e. EU-REACH registrations and exemptions from test requirements. It is unclear if registrants will be allowed to use weight of evidence approaches, read-across, QSAR and exposure based waiving for K-REACH registrations.

DHI hosts workshop in Korea
Together with our collaborating partner KIST Europe and the Korean Ministry of Environment, we are hosting a workshop in Seoul, Korea in November 2015 for the industry. Among the participants is the industry attaché from the Danish Embassy in Korea. Topics will be general introduction to K-REACH, challenges for registrants and strategy of European companies for K-REACH compliance.

For further information on K-REACH, please contact

Brian Svend Nielsen
bsn@dhigroup.com
Tel +45 4516 9140

Jens Tørsløv
jet@dhigroup.com
Tel +45 4516 9022


Successful REACH enforcement

One of the messages from the Enforcement Summit Europe in Brussels in October was that the EU enforcement of REACH is successfully carried out by the member states. A recent European Commission study found an average of 80% compliance during audits carried out by local EU enforcement authorities. Companies are urged to be prepared for such audits to avoid receiving any warnings or paying fees.

Furthermore, the discussions at the Summit confirmed an increasing interest in harmonisation of different global chemical legislations. However, this is acknowledged to be a long-term aim.

For more information, please contact Summit delegate

Hülya Genc-Fuhrman
hgf@dhigroup.com
Tel +45 4516 9256


Denmark leads drive for stronger chemicals initiatives

In late October, the Danish Chemicals Forum sent an open letter to the European Commission, ECHA and European chemical stakeholders strongly urging them to sharpen the focus on chemicals initiatives in the EU.

It is eight years since REACH was adopted and the Forum argues that improvements are needed. In the letter, the Forum refers to the fact that 60% of REACH registrations are incomplete or inadequate and encourage stronger enforcement so that free-riders do not undermine work by responsible enterprises.

Focus areas and suggested actions
The Forum lists five focus areas: REACH registrations, phase-out of Substances of Very High Concern (SVHC), endocrine disruptors, nanomaterials, and import of articles containing substances subject to registration. Among the actions to be undertaken, The Forum recommends empowering ECHA to reject dossiers not fulfilling the requirements, to accelerate phase-out of SVHCs, and to expedite measures for endocrine disruptors and nanomaterials.

Worries about imported articles
Furthermore, the Forum calls for implementation of restrictions to prevent import of articles containing substances subject to authorisation from countries outside the EU. Without obstacles to import such articles, it could encourage EU enterprises to move production outside the EU.

The Chemicals Forum includes all stakeholders in the chemicals area in Denmark. Read the open letter: Sharper Focus on EU Chemicals Initiatives.

For more information, please contact

Anne Rathmann Pedersen
arp@dhigroup.com
Tel +45 4516 9370


Repeat of webinar: Notification of chemical products in Denmark

If you missed our free webinar in October, please join us when we repeat the webinar in early January.

Chemical substances and mixtures placed on the Danish market may be subject to product notification to the Danish Working Environment Authority. Join our free webinar and learn more about which products have to be notified, who are obliged to notify products and what information is required.

Target group: The webinar is in English. It addresses both Danish and international manufacturers, suppliers and importers of chemical products to the professional market in Denmark.

Date: Tuesday 19 January 2016 at 3 pm – 3.45 pm (Danish time, UTC +1)

Sign up: If you want to join the webinar, please send an e-mail to Vibeke Salmon: ves@dhigroup.com


Biocides

Decision on approval of ethanol postponed

The approval of ethanol as a biocidal active substance for product types PT 1, 2 and 4 has been long awaited by the disinfectant industry. According to the previous working programme from ECHA’s Biocidal Products Committee (BPC), the decision on ethanol was supposed to be taken in the first quarter of 2016.

However, according to the latest version of the BPC’s working programme from 15 October 2015, the decision on ethanol has been moved to the fourth quarter of 2016. Consequently, the national transitional rules for biocidal products containing ethanol continue to run for a longer period accordingly.   

For questions on biocidal products, please contact

Michael Fink
mif@dhigroup.com
Tel +45 4516 9156


Sustainable use of biocides

DHI has prepared a report with an overview of identified solutions and tools for sustainable use of biocides. The report contains suggestions for possible initiatives at Danish national level and at EU level. Five product types were prioritised based on the number of active substances falling under the exclusion criteria or because they might be considered as candidates for substitution according to the BPR regulation:

PT 2:                   disinfectants and algaecides
PT 8:                   wood preservatives
PT 14:                 rodenticides
PT 18:                 insecticides
PT 21:                 antifouling products

View the report Survey and strategy for sustainable use of biocides.

The project was initiated by the Danish Environmental Protection Agency and has been carried out together with Milieu, legal consultants.

For more information, please contact co-author

Michael Fink
mif@dhigroup.com
Tel +45 4516 9156


Cosmetics

News about cosmetic ingredients

The preservative Quaternium-15 (INCI name) has been deleted from the list of preservatives approved for use in cosmetics in the European Union. Quaternium-15 is CMR classified (toxic to reproduction, cat. 2) and already generally forbidden for use in cosmetics. The substance is not widely used in cosmetics in the EU, but more frequently used outside of the EU.

Zinc oxide approved as UV filter
In the EU, the substance zinc oxide has been approved for use as a UV filter in cosmetics, including the use of zinc oxide in nanosize. The European Commission’s Scientific Committee on Consumer Safety (SCCS) has evaluated that the substance is safe for use in amounts up to 25% in sun protective products.

For questions concerning cosmetic products, please contact

Ann Detmer
ad@dhigroup.com
Tel +45 4516 9103


Cosmetics may harm the environment

Some substances used in cosmetic products are used in amounts so small that there is no regulatory requirements to assess their environmental impact. And yet, the substances may still be harmful to the environment. Some substances have endocrine disrupting effects, others are very bioaccumulative in the environment and may end up in the food chain.

Senior toxicologist Ann Detmer has written an article to a Danish periodical on cosmetics, Fagbladet Kosmetik, on how to assess environmental impacts of cosmetics and the regulatory requirements. To read an English text of the article, click here.

For questions on cosmetics and environmental impacts, please contact

Ann Detmer
ad@dhigroup.com
Tel +45 4516 9103


Food

Botanical health claims and nutrient profiles expected by 2017

The European Commission has decided that botanical health claims and nutrient profiles are among the focus areas that the Commission will prioritise in its 2016 work programme.

The legislative work is scheduled to commence in early 2016 and a completion date is set for June 2017.
The purpose is to prepare nutrient profiles and health claims on plants and their preparations. At the moment approx. 2,000 botanical health claims are on hold in the EU, and nutrient profiles were originally supposed to have been set by 2006.

For more information on claims and nutrient profiles, please contact

Helle Buchardt Boyd
hbb@dhigroup.com
Tel +45 4516 9097


New novel food rules almost adopted

If the European Council and the European Parliament can agree on a few technical issues, then new rules on novel foods can be expected to be adopted soon. If so, the current novel food rules will be replaced for the first time in almost 20 years.

The major changes will be:

  • A 50% nanomaterial threshold
  • Applications to be processed by the Commission and the European Food Safety Authority (EFSA) instead of the EU member states
  • EU market to open up to products that have been traditionally consumed outside of the EU for many years

A two-year transition period will apply when the new rules come into force.

For information on novel foods, please contact

Helle Buchardt Boyd 
hbb@dhigroup.com
Tel +45 4516 9097


Paper and cardboard for food contact

The European Council is preparing new technical guidelines for testing of paper and cardboard for direct and indirect contact with food.

A number of standards already exist for testing as well as threshold limit values for release of certain substances from paper and cardboard, in particular recycled paper and cardboard. These will be included in the coming technical guidelines.

The first draft of the technical guidelines was presented by the undersigned at a Danish seminar in October.

For more information on safety assessment of food contact materials, please contact

Helle Buchardt Boyd 
hbb@dhigroup.com
Tel +45 4516 9097

Courses and webinars

More news on courses and webinars in our next newsletter.

See our remaining courses (in Danish) on our website.



Meet us

ECHA session on new registration process, Brussels
Anne Rathmann Pedersen participated in this session on upcoming changes in tools and processes involved in the registration of substances under REACH. The session took place on 4 November in Brussels.

European REACH Congress 2015, Germany
A DHI delegate will participate in the European REACH Congress 2015. The congress takes place in Düsseldorf, Germany, on 24-25 November.

BWMTech, London
Gitte I. Petersen and Torben Madsen participate in the Ballast Water Management Technology conference in London on 8 - 10 December 2015. Gitte has also been invited to speak at the conference.


Contact

To sign up for the newsletter:
Please send an e-mail to ves@dhigroup.com – write Subscription newsletter in the subject line.


DHI | Agern Allé 5 | 2970 Hørsholm | Denmark
Tel: +45 4516 9200 | Fax: +45 4516 9292 | www.tox.dhigroup.com



Copyright DHI. All rights reserved


This newsletter was sent to you by DHI in response to your registration.
All details are treated confidentially and will not be transferred to third party.