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QA & Regulatory Support
PCAS & REACH
PCAS & REACH - FAQs

The intention of PCAS is to safeguard the supply of all substances and preparations currently manufactured for our customers.
The following answers to FAQs give the outlines of how PCAS will manage the compliance with the new regulation.

How did PCAS prepare the (pre) registration?

The PCAS REACH team completed comprehensive listings of raw material, final products and intermediates from the 3 last reference years in order to assess the tonnage bands. Both marketed and internally used intermediates constitute 1/2 of about 600 substances (approximately) subject to (pre)registration.

PCAS joined expert groups and associations in order to prepare SIEFs and to share knowledge and experience.

The relevant IT systems for enabling communication with ECHA (IUCLID 5 and REACH IT) have been put in place including the training of people in charge of (pre) registration.

 

Which PCAS substances / preparations will be pre-registered under REACH?

Almost all the substances and preparations manufactured by PCAS are "phase in" and will be pre-registered with the exception of:

  • those already registered under Elincs (already considered as registered)
  • new substances or preparations for which PPORDS notifications have already been completed in June 2008
  • APIs
  • Some polymers

Pre-registration has been completed for about 1/3 of all the substances as of July 31st, 2008. They all will be by late November 2008.

 

How does PCAS manage the confidentiality issues (e.g. neither manufacturer nor customer shall be identified by potential competitors)?

A contract has been signed with a third party representative; this third party is indicated to ECHA in the pre-registration application upon customer and/or PCAS decision.

 

What if the customer wishes to act as the third party?

This is also a possibility if the customer is based in the EU, but in such a case there is only a partial preservation of confidentiality.

 

What about PCAS's own raw material suppliers?

Through the listings of raw materials and suppliers, EU based manufacturers, EU based suppliers of non EU productions and direct import have all been identified. Contacts have been established with all the suppliers in order to make sure they will meet their legal obligations under REACH.

Direct imports by PCAS (about 15 on hundreds of supplies) have been subjected to agreements with the given foreign manufacturers PCAS takes care of  pre-registration (acting as "only representative" for those manufacturers).

 

How do you intend to register intermediates?

Almost all the intermediates manufactured by PCAS will be in the limited registration scheme (art 17 or 18) for the protection of our operators, the protection of environment and GMP requirements.  Those are manufactured and handled in strictly controlled conditions.

 

When registering the substances you supply to us, will our specific use be covered by your company?

PCAS anticipated this point by the implementation of a specific MSDS (material safety data sheets) management system which takes that aspect (as well as the GHS) into consideration, the updating of MSDS has started and customers are contacted to make sure their specific uses of their substances are considered.