|Povinnosti výrobcu, dovozcu alebo distribútora elektronických cigariet a plniacich fľaštičiek|
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Výrobca, dovozca alebo distribútor elektronických cigariet a plniacich fľaštičiek je povinný predložiť Slovenskej obchodnej inšpekcii a ministerstvu oznámenie
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency,amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC came into force on 1st June 2007 and replaces a number of European Directives and Regulations with a single system.
REACH will apply in stages and to allow a phased transition from the existing regulatory regime to the new regulatory regime under REACH.
REACH is a strategic business issue with technical requirements impacting many facets of business. One of the first things for companies to prepare themselves for REACH is to make an initial assessment of the potential impact of REACH on their organization. REACH will hit the chemical and downstream industries hard from May 2010.
Current deadlines are clearly arising from this first wave of registration, which is theoretically the 30.000 substances pre-registered substances such as high volume (over 1000 ton per year) or very dangerous substances (carcinogenic, mutagenic, toxic to reproduction, and very dangerous for the environment). Current is expected that registration will be made for approximately 50% of the initially pre-registered substances. In the short time we will assess the eligibility of such assumptions.
Late pre- registration
Þ at the latest six month after its manufacturing or import, and
Þ at least 12 months before the relevant deadline for registration.
Downstream user (use chemicals to professional activities) should inform their suppliers about use of the substance or mixtures, if they want to incorporate it in the chemical safety assessment. On the other hand the downstream users can carry out the assessment later and can perform their duties alone. Downstream users for communication have to use a written form and have to od it in specific period.
REACH requires manufacturers and importers of hazardous substances to prepare chemical safety report and exposure scenarios which describe the conditions necessary to control the risk (risk management measures) for the use of chemical substances. Exposure scenarios (ES) are attached to the safety data sheet (SDS) and include safety instructions regarding use of chemical substances which are subject of communication between suppliers and downstream users after registration.
Substances of Very High Concern (SVHC)
In general terms, Substances of very high concern (SVHC) are substances that have hazards with serious consequences, e.g., they cause cancer, or they have other hazardous properties and/or remain in the environment for a long time with their amounts in animals gradually building up. SVHC are defined in Article 57 of Regulation (EC) No 1907/2006 (“the REACH Regulation”).
In the framework of the authorisation process under REACH the European Commission will adopt decisions to include substances in Annex XIV (Authorisation List) that appear on the Candidate List of Substances of Very High Concern for Authorisation. ECHA published first Candidate List on website 28 October, 2008.
The identification of substances as Substances of Very High Concern and its inclusion in the Candidate List is the first step in the procedure concerning authorisation. Companies have legal obligations resulting from the inclusion of the substances in the Candidate List from the date of inclusion.
For the substances on the Candidate List that are prioritised, ECHA has developed a draft recommendation of 7 substances for inclusion in Annex XIV - Authorisation List
Article suppliers will be obliged for Candidate list substances determination in articles according to article 33. Usually the manufacturer know what they articles are composed from. This does not necessarily mean that they know the detailed composition of substances and preparations in the articles they sell. SMDS contain information about the presence of substances which are already classified as dangerous, but not the exact concentrations of the substances. Relevant information can be gathered by up and down communicating trough the supply chain. The supply chain issue is a key topic related to REACH.