EU Legislation – REACH
The last time we wrote about REACH was in our second newsletter, published in spring 2007, about the main objectives as well as the timing until REACH is fully implemented.
By now we believe most of the players in our industry are aware of the impacts REACH will pose and consequently have formed task forces, improved communications up and down the supply chain and evaluated the approximate costs for the registration process.
Still there is a great amount of uncertainty and various questions are subject to continued discussions such as
- which substances could be possibly withdrawn due to the registration
cost factor - how to clearly identify substances to avoid implications for the continued use
- is my supplier going to pre-register or do I have to deal with an only
representative and if so do I still register to warrant my options - what about my intellectual property when it comes to data sharing
These are only some questions out of many since REACH is very complex.
As the pre-registration process will take place very soon here below you will see main aspects of pre-registration. We also take a quick look at what happens shortly after the pre-registration deadline.
If you fail to pre-register your substance(s) within the period above, you will not be able to participate in Substances Information Exchange Forums (SIEFs) and should proceed to the registration phase with no additional delays in regard of the applicable deadlines based on substance tonnage bands and properties.
Depending on the pre-registered substances nature and volumes put on the market, qualified pre-registered substances are benefiting transitional periods that range from 2 to 10 years (2008-2018) to fulfil the registration process.
Who shall pre-register?
- Manufacturer of chemical substances
- Importer of chemical substances
- Chemicals Formulator
- Importer of Articles (substances to be released Art. 7.1)
- Producer of Articles (substances to be released Art 7.1)
- Only Representatives (legal proxies of foreign manufacturers)
What information you need to pre-register?
- Substance name incl. CAS/EINECS No’s or similar identification codes
- Full registrant details or nominated 3rd party representative
- Applicable deadline for registration
- If you wish, for similar substances name and identification
How to pre-register?
- Pre-registration dossiers should be sent to Agency (ECHA) through IUCLID 5
system (IUCLID 5: International Uniform Chemical Information Database 5 is
a newly developed software application to facilitate the creation of dossiers
to comply with the data requirements of REACH The IUCLID 5 software can
be obtained now free of charge from the http://iuclid.eu server.
Before downloading you will be requested to sign up).
So far so good.
Knowing now who, what information and how and to pre-register each company should verify its current position before pre-registration process takes place in respect of
- what is my position within the supply chain
- identifying the substances your company needs to pre-register or
- identifying the substances you want your supplier to pre-register
in order not to be withdrawn from your supply chain. - identifying alternative substances for those vulnerable to withdrawal
- developing an inventory of your substances and their supply chain
Each company is differently positioned depending whether they are manufacturers, importers or downstream user and so is the action they will take and the questions they have respectively.
The European Commission has funded number of projects known as RIPs (REACH Implementation Projects). RIPs are intended to guide companies to understand what is expected to ensure compliance. Of particular interest to the industry is RIP 3. Divided into many subsections it will provide detailed guidance. Please see http://ecb.jrc.it/REACH/RIP/
Another tool is the NAVIGATOR, developed by the ECHA and is meant to guide you through the thousands of pages of guidance. The navigator will guide you to your obligation on a given substance based on the answer the user gives to the questions of the navigator. Please see http://reach.jrc.it/navigator_en.htm
In addition national helpdesks were established to answer your questions.
Please see http://echa.europa.eu/reach/helpdesk_en.htm
The first registration deadline is only two years after the end of the pre-registration period for the following phase in substances in quantities
- > 1000 t/a by December 1st, 2010
- > 100 t/a (R50/53) by December 1st, 2010
- > 1 t/a Category 1 or 2 CMR’s by December 1st, 2010
By December 31st, 2008 ECHA will publish on its website a data base of all pre-registered phase-in substances. All pre-registrants of the same substance will participate in SIEFs (Substance Information Exchange Forum) to coordinate and agree on existing data, co-operate on new studies to avoid duplicate testing especially those on animals.
Read more on REACH in the next hocem newsletter.
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