Ms Connie Lau, REACH Officer, leads the REACH program for TÜV SÜD South China.
Her role involves developing the range of REACH services to address the unique challenges faced by the client industries through close partnership with TÜV SÜD’s management system and chemical experts from the region.
REACH Webinar Slide 2 Contact information: Connie Lau REACH Officer TÜV SÜD Hong Kong : +852 2443 3774 : firstname.lastname@example.org
What is REACH? REACH Webinar Slide 3 What is REACH?
What is REACH? Regulation (EC) No 1907/2006 REACH (the Registration, Evaluation, Authorisation and restriction of Chemicals)
A single harmonised framework for chemicals management that amends and replaces 40 existing chemical legislations.
It places the responsibility onto the manufacturers, importers as well as downstream usersto ensure the chemicals that are put on the EU market do not adversely affect human health or the environment.
It aims to protect human health and the environment from the adverse effects of chemicals.
Consumer products (articles) are also under control.
Slide 4 REACH Webinar
What is REACH? Regulation (EC) No 1907/2006 REACH (the Registration, Evaluation, Authorisation and restriction of Chemicals) Slide 5 REACH Webinar
What is REACH? Regulation (EC) No 1907/2006 REACH (the Registration, Evaluation, Authorisation and restriction of Chemicals) Registration
Customs boundaries EU 27 3 EEA Austria Germany Netherlands Belgium Greece Poland Bulgaria Hungary Portugal Cyprus Ireland Romania Czech Italy Slovakia Republic Denmark Latvia Slovenia Estonia Lithuania Spain Finland Luxembourg Sweden France Malta United Kingdom REACH Webinar Slide 10 Iceland Liechtenstein Norway Switzerland
Customs boundaries EU 27 3 EEA Austria Germany Netherlands Belgium Greece Poland Bulgaria Hungary Portugal Cyprus Ireland Romania Czech Italy Slovakia Republic Denmark Latvia Slovenia Estonia Lithuania Spain Finland Luxembourg Sweden France Malta United Kingdom REACH Webinar Slide 11 Iceland Liechtenstein Norway Switzerland
Why does REACH concern me? REACH Webinar Slide 12 Customs Borders Upstream Non-EU Substance Manufacturer Non-EU Mixture Formulator Non-EU Article Producer EU Importer EU Retailer EU Distributor Downstream
Why does REACH concern me? Upstream Downstream REACH Webinar Slide 13 Customs Borders Non-EU Substance Manufacturer Non-EU Mixture Formulator Non-EU Article Producer EU Importer EU Retailer EU Distributor
Definitions Substance = Chemical Substance Substance in mixtures Substance in articles e.g. Washing powder e.g. Fabric e.g. Calcium chloride (A common household desiccant ) Substance in articles intended to be released Article – an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition e.g. Fabric with a microencapsulated chemical Slide 15 REACH Webinar
Substances in articles intended to be released#
That are imported into the EU at ≥ 1 tonne / substance / year / legal entity must be registered. *Exemptions are listed in Article 2, Annex IV, Annex V of REACH regulation. # Registration is not required for the substances if they have already been registered by any registrant (not necessarily from the same supply chain) for the same specific use. Slide 21 REACH Webinar
WHO is eligible to register? Customs Borders Upstream Non-EU Substance Manufacturer Non-EU Mixture Formulator Non-EU Article Producer EU Importer EU Retailer EU Distributor Downstream Slide 22 REACH Webinar
WHO is eligible to register? Customs Borders Upstream Non-EU Substance Manufacturer Non-EU Mixture Formulator Non-EU Article Producer EU Importer EU Retailer EU Distributor Downstream Registration must be carried out by an Only Representative (OR). Slide 23 REACH Webinar
WHEN to register? For registration purposes, chemicals are divided into 2 types: 1 2 Phase-in (existing, EINECS): Non phase-in (new, ELINCS): Full registration from 1 June 2008. If pre-registered before 1 Dec 2008, then depending on hazards and tonnage:
LATE pre-registration Late pre-registration deadline and requirements after 1 December 2008
Import for the first time a phase-in substance; or
Import for the first time an article containing a phase-in substance that would require registration
at ≥ 1 tonne / substance / year / legal entity
Carried out within six months of first importing; and
No later than 12 months before the relevant extended registration deadline
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Do I need to register? REACH Webinar Slide 27 Registration is a very expensive and lengthy procedure. If you think registration may apply to your products, it is highly recommended that you speak with an Only Representative who can help you correctly identify your obligations and also provide advice on the best options for minimising costs.
Restriction REACH Webinar Slide 29 Up until 30 May 2009: Directive 76/769/EEC - restrictions on the marketing and use of certain dangerous substances and preparations.
Restriction REACH Webinar Slide 30 Up until 30 May 2009: Directive 76/769/EEC - restrictions on the marketing and use of certain dangerous substances and preparations. Since 1 June 2009: AnnexXVII of the REACH regulation. There have been 2 amendments so far:
“A substance on its own, in a mixture or in an article, for which Annex XVII contains a restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction.”
Each restricted substance has its own limit
A restricted substance found to be above limit may result in the product being
SVHC SVHC - Substances of very high concern Slide 36 REACH Webinar
SVHC What is a Substance of Very High Concern? Carcinogenic, Mutagenic or Toxic to Reproduction (CMR), category 1 or 2. Persistent, Bioaccumulative and Toxic (PBT) orvery Persistent and very Bioaccumulative (vPvB). Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to human health or the environment of an equivalent level of concern as those above (e.g. endocrine disrupters). Slide 37 REACH Webinar
SVHC Aim: To ensure substances of very high concern (SVHCs) are eventually replaced by less dangerous substances or technologies, where suitable economically and technically viable alternative are available. Procedure:
A “Candidate List” of SVHCs is drawn up
SVHCs are prioritised from the Candidate List to be put on
Annex XIV for authorisation
Use of an SVHC on Annex XIV will be prohibited after its
“sunset date” unless authorisation has been granted for that use Slide 38 REACH Webinar
REACH Webinar Slide 39 SVHC, Candidate List and Annex XIV ECHA Draft Recommendation, Public Consultation, Member State Committee Opinion Member State / European Commission Submission Candidate List (Communication) (Notification) Annex XIV (Authorisation) SVHC Public Consultation, Decision by Member State Committee or Commission ECHA Recommendation, EU Legislative Procedure
SVHC – Obligation SVHC - Obligation Candidate List Communication along the supply chain Slide 40 REACH Webinar
The Candidate List At present, the Candidate List contains 38 SVHCs. These were announced on the following dates: REACH Webinar Slide 41
The Candidate List – Communication Along the Supply Chain If an article contains any SVHC on the Candidate List at > 0.1% w/w Immediately inform the recipient of the SVHC information SVHC information:
the name of the SVHC
instruction for the safe use of the product, if available
Consumers have the right to request SVHC information on a product, and the following information must be provided within 45 days Note:
No specified methods on how this information must be communicated.
Packaging materials are also defined as articles.
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Definition - 0.1% w/w Definition of 0.1% w/w:
SVHC – Candidate list SVHC - Obligation Candidate List Notification Slide 48 REACH Webinar
Notification Notification to the ECHA applies only to articles that contain: 1. An SVHC listed in the Candidate List at > 0.1% w/w, and 2. Total quantity of this SVHC at > 1 tonne/year/legal entity unless 3. Human and environmental exposure can be excluded during normal or reasonably foreseeable conditions of use including disposal, or 4. The SVHC has already been registered for the specific use
If the ECHA suspects that the SVHC may present a risk to human health or the environment then a registration of the SVHC may be required.
Notification requirement also applies to packaging materials.
REACH Webinar Slide 49
Notification Information to be submitted for a notification:
Authorisation Authorisation began on 1 June 2009. The use of an SVHC on Annex XIV will be prohibited after its “sunset date” unless authorisation has been granted for that use.
1 June 2009: the ECHA submitted the recommendation on 7 SVHCs to the European Commission for voting into the legislation.
1 July 2010: a 3-month public consultation began for the 2nd recommendation, which contains 8 SVHCs.
The ECHA shall make further recommendations at least once every 2 years.
REACH Webinar Slide 53
Authorisation – Annex XIV REACH Webinar Slide 54
Authorisation REACH Webinar Slide 55 Although authorisation does not apply to imported articles, it may still be of commercial interest to a non-EU producer of softlines products to be aware of the development of SVHCs on Annex XIV.
Relevant URLs The European Chemicals Agency (ECHA) http://echa.europa.eu/home_en.asp Member State national helpdesks http://echa.europa.eu/help/nationalhelp_contact_en.asp Candidate List http://echa.europa.eu/chem_data/authorisation_process/candidate_list_en.asp Annex XIV http://echa.europa.eu/chem_data/authorisation_process/annex_xiv_rec_en.asp Guidance Documents http://guidance.echa.europa.eu/guidance_en.htm REACH Webinar Slide 56
Thank you! Slide 57 REACH Webinar This information provided herein is of a general nature and is not intended as professional advice services. TÜV SÜD makes no warranties or representations, expressed or implied, as to the accuracy or completeness of the information provided herein. If you are seeking advice on any matters relating to information provided herein, you should – where appropriate – contact us directly with your specific query or seek advice from qualified professional people.