Effective December 19, 2011, the European Chemicals Agency (ECHA) has added another twenty 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 twenty substances are the following:
|1.||Lead dipicrate||CAS No. 6477-64-1|
|2.||Lead styphnate||CAS No. 15245-44-0|
|3.||Lead diazide||CAS No. 13424-46-9|
|4.||Phenolphthalein||CAS No. 77-09-8|
|5.||2,2′-dichloro-4,4′-methylenedianiline (MOCA)||CAS No. 101-14-4|
|6.||N,N-dimethylacetamide (DMAC)||CAS No. 127-19-5|
|7.||Trilead diarsenate||CAS No. 3687-31-8|
|8.||calcium arsenate||CAS No. 7778-44-1|
|9.||arsenic acid||CAS No. 7778-39-4|
|10.||bis(2-methoxyethyl) ether||CAS No. 111-96-6|
|11.||1,2-Dichloroethane||CAS No. 107-06-2|
|(4-tert-Octylphenol)||CAS No. 140-66-9|
|13.||2-Methoxyaniline, o-Anisidine||CAS No. 90-04-0|
|14.||Bis(2-methoxyethyl) phthalate||CAS No. 117-82-8|
|15.||Formaldehyde, oligomeric reaction|
|products with aniline (technical MDA)||CAS No. 25214-70-4|
|16.||Zirconia Aluminosilicate Refractory Ceramic|
|17.||Aluminosilicate Refractory Ceramic Fibres (RCF)||—|
|18.||Pentazinc chromate octahydroxide||CAS No. 49663-84-5|
|19.||Potassium hydroxyoctaoxodizincatedichromate||CAS No. 11103-86-9|
|20.||Dichromium tris (chromate)||CAS No. 24613-89-6|
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.
In addition, notification of svhc according to article 7 REACH may apply on manufacturers or importers of articles if a svhc is present above 0,1 mass% and in a total > 1 ton/year and exposure of the svhc (including disposal) cannot be excluded . After a new substance is added to the candidate list, companies have a 6 months period of time for submitting the notification to the European Chemicals Agency.
Find the complete list of 73 candidate substances here: Candidate List
Estonia has been the first off the mark in implementation of the new requirements of the RoHS directive 2011/65/EU into national legislation. As the RoHS (II) directive was published on July 1, 2011, member states have an 18- months time period until January 2, 2013 for the transition.
Estonia has implemented the labeling requirements for electronic and electrical equipment (EEE) including the CE marking in the „Elektri- ja elektroonikaseadmete märgistamise viis ja kord“. Although the changes have been published in the late 2011, the legislation will come into force January 2, 2013.
Other member states are working on the implementation already and further publications are expected soon. If a member state will miss the deadline for January 2, 2013, the requirements of the directive 2011/65 will apply anyway as it has regard to the „Treaty on the Functioning of the European Union“, in particular Article 114.
Currently, companies have to prepare for the requirements for the technical documentation and internal manufacturing control which will be required for the RoHS CE marking. From January 2, all EEE brought on the EU market has to comply with the new RoHS directive, implemented in 27 national legislations in the EU member states.
Several exemptions of the restriction of hazardous substances directive (RoHS) expire at the end of 2011.
In most cases, it concerns the concentration limits of mercury in illuminants are concerned. Up to now, those products had permission for the use of mercury as an exemption of the RoHS directive without limits. From January 1, 2012, many different types of illuminants have to comply with certain concentrations limits of mercury (in milligrams) per lighting unit.
Another exception expires completely: Cadmium and its components is no longer allowed to be put on the market after January 1, 2012 in one shot pellet type thermal cut-offs.
Other exceptions of the restriction of hazardous substances in electric and electronic equipment (EEE) will expire just one year later, end of 2012.
Today, November 24, 2011, the German transposition of the Eco-Design-Directive (2009/125/EC), the “Energieverbrauchsrelevante-Produkte-Gesetz”, (EVPG, energy–related product law) has been published in the German Federal Law Gazette and will come into force tomorrow on November 25, 2011. It will replace the current “Energiebetriebene-Produkte Gesetz”, (EBPG, energy using products act) which was the German transposition of the EuP–Directive 2005/32/EC.
Important changes on the legislation will be:
• An extended scope to all energy-related products
• In the future, the law will comprehend also products whose usage
aaahas an impact on energy consumption like windows, insulation
• Market surveillance will take place on the entire supply chain, from
aaathe manufacturer to the retailer according to regulation
• In addition to manufacturers, also importers and resellers have to
aaaensure that the products they place on the market are compliant
aaato the legislation.
The CLP adaption law leads to changes in several German legislations.
Although the CLP legislation was issued as a regulation, that means, it applies directly in any member state, a few ordinances have to be implemented in national legislation of the different member states.
As in 2008, the REACH-adaption law already cut down most parts of the German ChemG (Chemical law) there are now only a few changes for the CLP-adaption.
Besides the numerous changes of definitions (mixture/preparation) and new names for European institution, there are important changes on the obligation of notification of dangerous preparations to the Poison Control Center. Up to now, only certain dangerous preparations that were sold to the broad public and biocides had to be notified. After the changes, any dangerous preparation, weather sold to the broad public or not, has to be notified. Even small tonnages are not exempted.
For those who now have to notify their preparation the first time, a transition period is granted, if they provide their safety data sheets to the Information Center for Safety Data Sheets (Informationsstelle Sicherheitsdatenblatt, ISi) of the Institute for Work-Safety (Institut für Arbeitsschutz, IFA) at the German State Accident Insurance (Deutsche Gesetzliche Unfallversicherung, DGUV).
In addition to the ChemG., the CLP adaption law has also impacts on the German ElektroG (implementation of the WEEE and RoHS directives), Wasch- und Reinigungsmittelgesetz (detergents) and Pflanzenschutzmittel (pesticides).
The new RoHS directive 2011/65 requires the CE mark and the EU declaration of conformity as a proof of compliance with the legislation. In order to being able to issue those evidences, a technical documentation (according to the EU decision 768/2008) is required.
As the new RoHS is based on a presumption of conformity if a device carries the CE mark, harmonized standards are absolutely essential for industry but don’t exist yet.
Therefore, the European Commission has recently mandated the three most important European committees and institutes CEN, CENELEC and ETSI to develop new standards for RoHS compliance. Those standards should enable manufactures of electrical and electronic equipment (EEE) to proof compliance with the substance restrictions and limitations in homogeneous material via e.g. testing results, material declaration or contractual agreements between manufacturers and suppliers. The standards should be convertible for all sizes of enterprises e.g. small and medium sized enterprises (SME).
The process of creating and issuing the new standards will take approximately one year. A publication of the new standards is therefore expected not before end of September 2012. This may result in shortage of time for manufactures, as the implementation into national legislation has to be realized until January 2, 2013 and will be legally valid then.
Although having no harmonized standards yet, manufacturers of EEE should start working on their technical documentation now. If, at the beginning of 2013, the required documentation for CE marking cannot be provided, the devices won’t be allowed to be put on the European market.
Presenting K&L’s Legal Monitoring services, an overview of the Californian legislation was explained at a workshop at the Fraunhofer IPA in Stuttgart.
In 1986, the “Safe drinking water and Toxic Enforcement Act”, better known as California proposition 65 went into force. The aim of this act is, to protect Californians from the hazardous impacts of carcinogenic or repro-toxical substances.
Therefore, a list of substances, first published in 1987, was setup. Steadily, more and more substances are added (and in few cases taken off) the list. Currently, the list contains around 850 substances.
A warning must be provided when any person is exposed intended or knowingly to a listed substance when using a product, being in a certain place etc. Consumers may face those warning signs everywhere in the daily life: On products in supermarkets, in underground parking areas, on sports and leisure equipment… just everywhere.
But what do the “people doing business” in California have to do in order to comply with this regulation? They need to know about substances in their articles that people are exposed to, about their concentrations and intended releases. But many additional questions arise:
• How to get all this information?
• Should I do testing on any product?
• What’s about information for imported articles or parts of articles?
• Can I trust the information provided by suppliers?
• Does knowingly means only exposure I REALLY KNOW about OR that
I SHOULD KNOW about?
After a new substance has been added to the list, a company has a 12 months period in order to comply with the warning requirements.
As the State of California also allows private person to enforce violation of the proposition 65, Non-Governmental-organizations (NGOs) and consumer protection association are surveilling the market and inform the responsible attorneys. Civil Lawsuits are held every year and tens of million Dollars of penalties have to be paid. Additional penalties for violation of Proposition 65 are withdrawal, ban of sales and, non-official penalties like the damage to one’s image…
Interested in additional information about this act and how to comply with it? Interested in environmental legislation in other countries in the world? Our research team is ready to answer your questions!
Substances of very high concern (SVHCs) fulfilling the requirements of the articles 57 and 59 REACH are put on the so called candidate list by ECHA (European Chemicals Agency). After a due commenting process, those substances may be put into REACH Annex XIV and will then be subject to authorization. This means that they are not allowed to be used without having an authorization from ECHA for that single use. On the other hand, they can still enter the EU as a substance in an article.
This, of course, is largely perceived as contradictory to one of the objectives REACH should achieve, namely the restriction of use of SVHCs. Furthermore, it may lead to the assumption, that manufacturers of articles may move their production facility into non-EU countries in order to import the finished or intermediate products containing SVHCs back into the EU. Presently, no authorization but only information obligations according to article 33 may apply then.
The REACH regulation, however, also provides another procedure in order to protect the consumer from the exposition and the impacts of CMR substances category 1A and 1B that belong to the SVHCs.Article 68.2 REACH regulation should take care of this. It says that the Commission is entitled to adapt or add restrictions for those substances, using a special procedure related to the council decision 1999/468/EC. As the CMR substances category 1A and 1B, amongst others, are in the focus for the candidate list, it seems quite likely, that substances listed in annex XIV will very soon also appear in annex XVII, restricted for the use in goods or articles that may be used by consumers.
The discussion of the reference value of an article has reached the next stage.
As Germany, Austria, Belgium, France, Sweden, Denmark and Norway still have a dissenting opinion on the information obligations of article 33 REACH regulation, suppliers of articles are facing different interpretations and enforcement activities in the different member states.
Basically, according to the wording of the law, companies have to inform the recipients of an article about candidate substances (substances of very high concern) > 0,1 mass%.
Recently, the German REACH and CLP Helpdesk has published a “short notice” as a supporting document for the fulfillment of the information duties according to the German understanding: once an article – always an article.
Enforcement activities referring to this understanding of the reference value will have strong impacts on industry.
The import of complex products (assembly of several articles) from outside the EU or from EU countries supporting ECHAs opinion will be faced with difficulties of receiving sufficient and veridical information about the article(s).
Plausibility checks and the risk-based- approach may help identifying or excluding the presence of candidate substances, but nevertheless, in many cases, the avoidance of cost-intensive testing won’t be possible.
After passing the first REACH registration deadline on December 1, 2010 and after having submitted the CLP notification to ECHA, REACH activities seem to be fallen asleep like sleeping beauty.
No significant news from ECHA, no action or movement in groups and forums, same lectures come up again and again, lab-workers playing pickup-sticks with test tubes?
Yes, but this is the quiet before the storm!
Although companies experiencing the efforts of REACH registration in 2010 call for an early starting of the registration activities for 2013, there does not seem to be a lot of action yet. ECHA expects the registration of approximately 3500 substances submitted in 25000 dossiers by mainly small and medium sized companies.
Many of those companies do not benefit from experience from the first registration deadline, do not have all relevant studies, do not have the expertise knowledge and the human resources. But they do have a lot of different specialty chemicals they have to register until the deadline on June 1, 2013.
What may happen?
Laboratories, consultants and service providers run out of capacity. In addition to the 2013 testing, laboratories will conduct the approved testing proposals from Annex IX and X submitted in 2010.
Difficulties, unforeseen incidents and external influences may delay your registration process. Start your registration process on time and do not risk of falling victim to article 5 REACH:
NO DATA NO MARKET!