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REACH - do seznamu kandidátů přibude nových 7 SVHC látek

Chemické látky
REACH - do seznamu kandidátů přibude nových 7 SVHC látek

ECHA informuje o rozhodnutí k zařazení nových 7 SVHC látek (látky vzbuzující velké obavy) na tzv. seznam kandidátů. Zařazení látky do zmíněného seznamu kandidátů znamená pro výrobce anebo dovozce nové povinnosti, zmiňme například povinnost oznámení SVHC látek obsažených v předmětech, a to nejpozději do 6 měsíců po zařazení látky do seznamu kandidátů.

The Member State Committee identifies seven new Substances of Very High Concern

Seven Substances of Very High Concern (SVHCs) will soon be added to the Candidate List. During its 18th meeting, the Member State Committee also unanimously agreed on four draft decisions based on ECHA´s testing proposal examination and on five draft decisions based on compliance checks.

Identification of SVHCs
The seven new substances identified as SVHCs are: 2-ethoxyethylacetate, strontium chromate, 1,2-Benzenedicarboxylic acid, di-C7-11 branched and linear alkyl esters (DHNUP), hydrazine, 1-methyl-2-pyrrolidone, 1,2,3-trichloropropane, 1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (DIHP). These substances are either carcinogenic, mutagenic or reprotoxic (CMR) substances. DHNUP and DIHP will complement the Candidate List with two additional phthalates.

In addition, as a result of the procedure for identification as SVHC a new identification basis (toxic for reproduction) will be added for cobaltdichloride that is already on the Candidate List because of its carcinogenic hazards. No comments challenging the new identification basis were received during public consultation and thus no formal agreement of MSC was needed for this case.

The Candidate List will be updated soon as the seven new substances and the "toxic for reproduction" will be added as the basis for identification as an SVHC for cobaltdichloride .

Dossier evaluation cases
As ECHA has commenced the evaluation of the dossiers from the first registrations, the number of dossier evaluation cases to be addressed in the MSC is expected to grow rapidly. The total number of MSC unanimous agreements on draft dossier evaluation decisions in 2011, at this point, is already higher than the total number of cases last year

MSC agreed unanimously to:

  1. four draft decisions on testing proposals confirming the testing proposals of the registrants as such or with some modifications.
  2. five draft decisions on compliance checks. These would require the registrant, for example, to refine the exposure assessment, the justification for Derived No Effect Levels (DNELs) and the assessment factors used in calculations when extrapolating the effects from animals to humans. In some other cases the draft decisions would request the registrant to provide missing information on environmental effects, like toxicity to aquatic organisms, terrestrial organisms and plants. In some draft decisions, compliance check information gaps regarding repeated dose toxicity and reproductive toxicity are also addressed.

In addition the MSC had already agreed through written procedure on two additional draft decisions on compliance checks and on one additional decision on a testing proposal.

ECHA will take the final decisions in accordance with the MSC unanimous agreement. The registrants can expect to receive the final decisions of ECHA within a few weeks time.

The Minutes of the 18th Member States Committee Meeting will be published on the ECHA/MSC website after their adoption by MSC.

Further Information

Draft agenda of the 18 MSC meeting:

Member State Committee web pages:

Candidate List of Substances of Very High Concern for authorisation:
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