REACH-inspection will focus on Downstream Users!

For the coming inspection activities, national inspectors will be especially trained on supervising the REACH and CLP obligations for Downstream Users.

As the role of the downstream users is essential in providing information about hazardous substances and a safe use, it is necessary to raise awareness about their duties for REACH and CLP.

Inspectors e.g. will check if
– Downstream Users comply with their obligation to inform users about
  substances in preparations
– they have checked that the substances they buy have been
  registered or not and
– they have followed their CLP notification duties.

As those inspections will start in summer 2011, we recommend double-checking and analyzing your obligations as a Downstream User in order to fully comply with REACH and CLP.

Revised RoHS directive expected for April 2011

After being adopted by the European Parliament in November 2010, the RoHS (Restriction of Hazardous Substances) recast is currently undergoing a thorough revision process by legal linguists. The formal council adaptation is expected in the course of March and, finally, the publication in the Official Journal should take place in April 2011.

The RoHS recast involves several changes for manufactures, importers and distributers.
Changes and facts in a nutshell:

•    Open product scope with various lists of exemptions
•    Grace period for equipment not falling under RoHS previously
•    Improved exemption process copying the REACH authorization
      process
•    Proceeding for including additional substances to be banned
•    Prove of RoHS compliance with CE mark
•    Labeling of products with name and address of the manufacturer
•    Appointment of an authorized representative
•    Extended local language product documentation required
•    Obligatory self denunciation of non-compliant products and
      components
•    Immediate corrective measures including withdrawal and recall

For industry, importers and traders, the RoHS recast results in new obligations for management of hazardous substances information within the supply chain and new documentation duties.

The implementation into national law will have to be realized until 2012 by the member states. Enforcement will be regulated by member states according to the regulation 765/2008 which became effective January 2010.

What happens to my dossier next?

Approximately 25.000 dossiers for 4.300 substances have been submitted to ECHA until December 1, 2010. What is the next step to follow?

The next step for ECHA will be the evaluation on the quality of the dossiers.

ECHA will evaluate at least five percent of the dossiers and will also focus on dossiers that e.g.

•    have different classification or study summaries in joint submissions
•    do not meet the requirements of Annex VII
•    contain waiving statements or are based on other substances data
      like e.g. “read across”
•    contain testing proposals for Annex VII or VIII
•    are for a substance that is difficult to test based on its chemical
      and physical properties
•    are in a bad quality, discovered e.g. in the testing proposals.

Discovering missing information, wrong or insufficient declarations, ECHA will inform the registrant(s) and will set an appropriate time-limit for submitting the required information.

However, registrants will also be granted a period of 30 days to interact with ECHA by commenting on ECHA’s decision or the decision of the Member State Committee.

Most deficiencies discovered by ECHA are based on non-specified substance identity, inadequate justified applications for QSAR, read across or grouping, incomplete exposure scenarios or inadequate justification for discrepancies of the information within annex VII to XI.

New challenges for the 2013 registration period

The first registration period has ended December 1, 2010, and most of the substances manufactured or imported by a company in high tonnages, i.e. above 1.000 tonnes per year, have been registered. SIEFs were often lead and supported by big companies and the global players.

For the coming registration period in 2013 a lot of medium-sized and small companies have to fulfill their registration duties. For them, REACH obligations may be a huge challenge regarding the capacity of personal, expertise and financials.

A company not having made their registration experience with the first wave in 2010 will discover several difficulties on the way to a successful registration.

A larger number of registrants, missing experience and expertise from the Lead Registrant as well as the other SIEF members may protract and bloat the whole process. Experienced companies as well as competent authorities recommend to start with preparations for the 2013 registrations in early 2011 and to seeking help and support in time when discovering unforeseen questions and issues.

Merry Christmas!

K&L offices are closed during Christmas Holidays, from December 24, 2010, until January 2, 2011.

We thank you for your confidence and are looking forward to working with you in 2011.

Merry Christmas and a Happy New Year!

REACH Candidate List expanded up to 46 SVHCs

Effective December 15, 2010, the European Chemicals Agency (ECHA) has added another eight substances to the candidate list of substances of very high concern (svhc) after the committee of the member states of the European Union had taken a respective decision. The eight substances are the following:

• Cobalt(II)sulfate, CAS-No 10124-43-3     
• Cobalt(II)dinitrate, CAS-No 10141-05-6
• Cobalt(II)carbonate, CAS-No 513-79-1
• Cobalt(II)diacetate, CAS-No 71-48-7
• 2-Methoxyethanol, CAS-No 109-86-4
• 2-Ethoxyethanol, CAS-No 110-80-5
• Chromtrioxide, CAS-No 1333-82-0
• Acids generated from Chromium trioxide and their oligomers

New candidate substances lead to a wider scope of obligations for the suppliers of articles. Information obligations, according to article 33 REACH, have to be fulfilled if an article contains more than 0,1 mass% of a candidate substance.

RoHS II ahead

November 24, 2010, the European Parliament voted on the RoHS recast. RoHS II is going to come into force in the beginning of 2011 and needs to be transposed into national law by the member states of the European Union within 18 month after publication.

RoHS II affects further branches and products and will lead to new obligations for the EEE industry.

Massive changes in the scope of RoHS as well as in the controlling and enforcement will hit industry in the years ahead.

The combination of the REACH regulation with its growing candidate list with the new RoHS directive makes a comprehensive, product-related management for toxic substances indispensable.

It’s high time for notification!

Your substance did not have to meet the 2010 registration deadline?
You started manufacturing or importing a substance since December 1st 2010?

Then you may have to submit a notification according to the CLP regulation (1272/2008) to the European Chemicals Agency for your substances within the next month. (January 3rd, 2011)

Registration of Chemicals on a Discount

The EU REACH Regulation requires producers of substances and/or preparations to register them on the website of ECHA, the newly created European Chemicals Agency in Helsinki. In the lowest tonnage band (1-100 t per year) the registration fee amounts to € 1.600,00 per substance max. However, fees might quickly make up a large sum if several substances have to be registered.

For substances put on the EU market in a volume between 1 and 10t per year there is no such fee for the registration (see Art. 74(2) of REACH Regulation). There is an important condition for the fee reduction to zero: the registration dossier must include all information stipulated in Annex VII to REACH Regulation.

New Partner for K&L in Asia Pacific

GISG Services, based in Kuantan, Malaysia, is K&L’s new partner for REACH Services in the Asian-Pacific region. As a chemical engineer with sound and long time experience in international companies like BASF, Selva Chelliah, managing director and owner of GISG Services, is the perfect link for Asia-pacific based companies to the REACH Services from K&L.

Companies from outside the EU that are operating or planning to operate within the European Union have to be compliant with REACH regulation. K&L offers REACH Services including Only Representative for non-EU companies, technical dossier, Chemical Safety Report, communication services, legal support and all other services that are necessary for a successful registration.

We are looking forward to having a successful partnership by providing REACH services to customers in the Asian-Pacific region.