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!
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.
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.
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)
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.
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.
BAuA (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, Federal institute for safety at work and industrial medicine) is the German competent authority for REACH, the so called MSCA in Germany. BAuA offers platforms to discuss crucial questions concerning the registration for chemicals under REACH. Only afterwards can local inquires out of Germany be escalated to ECHA. Accordingly, the respective meetings are very well frequented.
Consultants of K&L participated in the most recent information event on the “A” within REACH, which stands for Authorization and also includes the restriction of chemicals.
Substances in annex XIV REACH have to be authorized. These substances are not permitted for production or import without an authorization by the European Chemicals Agency (ECHA).
Substances in annex XVII REACH are in principle permitted for production or import but are restricted for certain uses. As an example, mercury is not eligible as a component in preparations used for preservation of wood.
The application for authorization has to be submitted to ECHA until a deadline specifically defined for each substance, allowing for an at least 18 months grace period until production or import will be prohibited without authorization. Both dates will be set by ECHA considering the type of substance and other criteria; e.g. the production cycle.
Currently; the following first six substances are scheduled for annex XIV by early 2011.
• 4,4′- Diaminodiphenylmethane (MDA)
• Bis (2-ethylhexyl)phthalate (DEHP)
• Benzyl butyl phthalate (BBP)
• Dibutyl phthalate (DBP)
Until 2012, the ECHA candidate list defining svhc-substances with a probability to be included in annex XIV will assumedly grow up to 136 items.
It is quite evident that companies’ responsibilities under REACH go far beyond registration obligations. The discussions at BAuA showed that there are still a lot of concerns. K&L will close pursue the progress of discussions and decisions.
Regarding the Copyright Levies for PCs in Germany, the industry is split: there are PC tariffs published on 29 April 2010 by the Collecting Society ZPÜ (Zentralstelle für private Überspielungsrechte) – which, however, have been rejected by the industry. The manufacturer association BCH (Bundesverband der Computerhersteller) meanwhile agreed upon their own tariff – which runs out by end of 2010! Thus, the situation remains unclear for both sides, the further process needs to be observed.
The Collecting Society ZPÜ published a new levy system this year without preceding successful negotiations, regarding the varying tariffs of PCs, Laptops, and Netbooks with and without integrated burners. These new tariffs are the basis for the claims of the collecting society, if so, retroactively as of 1 January 2008, for all PCs sold or imported. According to a statement of the Industry Associations, the negotiations are not over yet. A final decision is expected not until the end of this year.
Obligated parties have various options to override the new tariffs. They can disagree with the tariffs, but this may lead to a court case versus the ZPÜ.
Another option was to join BCH. This Industry Association has concluded an agreement with ZPÜ for reduced tariffs for these products, although they are in effect retroactively from 2008 to December 2010.
Finally, a Russian Collecting Society is officially authorized! However, it is none of those which so far were supposed to be selected.
Negotiations about copyright levies in Russia are apparently over. On 14 October 2010, the Decree of the Government of the Russian Federation No. 829 finally approved the negotiated scope and tariffs. A few days later, October 26, 2010, the Russian Union of Rightholders was authorized as the competent collecting society. According to a statement of the Collecting Society, payment will start without any delay and there is no pending trial.
Decree No. 829 states an extensive scope of products and except reprographic devices almost all product categories are part of the scope. Some administrative questions still remain unanswered.
The further development, however, needs to be monitored closely. In Russia, the situation may change fast.
Members of a consortium or a SIEF have to decide if the CSR is part of the Joint Submission or not (Article 11.1). There are three different procedures to choose.
1. Joint CSR for all registrants:
The Lead Registrant submits Part A and Part B in behalf of all members of the joint registration.
This procedure has the advantage that there is only one CSR for the substance and all information is submitted comprehensively.
It shows, however, disadvantages by being intricately when changes, updates or new registrants’ uses have to be added because additions to the registration dossier has to be done via the Lead Registrant. Moreover, in order to comply with competition law, trustee services may be necessary.
2. Partial Submission of a Joint CSR
The Lead registrant submits part B of the CSR jointly for all registrants and ticks the box for “Joint submission” in IUCLID, the registration software of the European Chemical Agency (ECHA). Then, every registrant submits individually part A of the CSR.
Furthermore, individual uses that are not covered by the Lead CSR Part B, can be added in a CSA by every registrant himself. Consortium members can also arrange that every joint registrant submits his own CSA for his uses when the Lead Registrant does not disclose his own uses and exposure scenarios.
This proceeding has the advantage that, if any updates or changes occur in a company, the Lead Registrant is not affected or involved in any administrative work.
3. Individual submission by every registrant
Every registrant submits CSR Part A and Part B on his own.
Lead Registrants or consortia may support their member registrants by providing a template of the common contents of the CSR.