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The pre-registration deadline ended by past Dec. 1st and the ones who have failed to do so are now subject to full registration with all its financial impacts.

hocem as an importer of NON-EU produced base oils successfully pre-registered its products with ECHA. We therefore are benefiting, likewise our customers, from the two year transitional period.

In January ECHA will address each pre-registrant giving information about:

• name of producers / importers who pre-registered the same substance
• the participation in SIEFs.

By mid year 2009 we expect ECHA to provide a detailed structure of the costs involved for the full registration process to start in 2010.

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• which substances could be possibly withdrawn due to the registration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.

In our first newsletter we informed you about the new EU legislation REACH (Registration, Evaluation and Authorization of Chemicals) which will come into force as of June 1st, 2007.

The current EU chemical policy consists of around 40 different legislative instruments. While new substances are intensely tested before they receive market approval this does not exist for substances introduced to the market before September 1981.

In order to stop the different handling of ‘new’ and ‘old’ chemical substances the EU legislation adopted in November 2006 the new REACH legislation which had its beginning as a first draft in October 2003.

The purpose of this legislation is a high level of protection for both health and the environment, to ensure free traffic for substances within the EU market and to balance this with the improvement of both, competitiveness and innovation.
Maxim of this legislation is that importers, manufacturers as well as downstream user shall only import, produce or use substances which do not pose a threat to human health and the environment.

Main objectives

• harmonized registration system of all (about 30.000) new and existing chemicals which are imported into or manufactured in the EU
• Importers and manufacturers will take responsibility of proof that their products will pose no threat to human health and the environment.
• downstream user need to provide detailed information with regard to handling and risk of substances.
• greater transparency to the public.
• supervision of REACH through the European Chemical Agency.

Timing

More important is the time frame set before REACH is fully implemented.
Depending on the annual tonnage imported or produced the following registration periods will apply after REACH will come into force on June 1st, 2007.

• pre-registration phase (about 18 months)
• registration of all substances from > 1000 t/a within 3 years (2010)
• registration of all substances from 10-100 t/a within 6 years (2013)
• registration of all substances from 1-10 t/a within 11 years (2018)

CMR substances (Carciogenic, Mutagenic, Reprotoxic) > 1t/a as well as high concern substances of classification N (R50-53) > 100t/a need also registration within the first 3 years.

Substances without registration will be excluded from further use or marketing.

In the following newsletters we will take a look at the registration process and the documentation needed.

The new EU regulation REACH (Registration, Evaluation and Authorization of Chemicals) will come into force as of 1st June 2007.

The impacts on our industry for importers and manufacturers will be highlighted in the coming hocem newsletters. Stay in touch!