REACH Industry Preparation Letter No 8

August updated version of April’s Letter

Pre-registration Guidance

This is the first in a series of three guidance documents to be provided by the Cefic Pre-registration Working Group to guide Cefic member companies through the key REACH challenges in 2008 and early 2009 including pre-registration, SIEF and data-sharing. This document provides guidance for preparatory work ahead of pre-registration and working together in SIEF and consortia. A second document was distributed in early June 2008 to provide guidance for the period after pre-registration through to the formation of SIEF. A final guidance on working together in SIEF and data/cost sharing is planned for mid October 2008.

Disclaimer

The information contained in REACH Industry Preparation Letter is intended for guidance only and whilst the information is provided in utmost good faith and has been based on the best information currently available, is to be relied upon at the user’s own risk. No representations or warranties are made with regards to its completeness or accuracy and no liability will be accepted for damages of any nature whatsoever resulting from the use of or reliance on the information. The guidance is based on information provided by the European Chemicals Agency and the interpretation of that information by CEFIC. The REACH- IT system is under development so differences might occur once the system is deployed.

Copyright

Copyright © of Cefic (AISBL), all rights reserved except for the Cefic members. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, mechanical, photocopying, recording or otherwise, without prior written permission of the owner. Cefic claims no copyright on any official document, such as the REACH guidance documents (whose abstract may be used in this publication) or information provided by the EU Institutions and ECHA. Please apply to Leo Heezen ()

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Table of contents
Pre-registration Guidance (overview) p.3
1. Preparation for pre-registration p. 4
What is pre-registration and why is it important? p. 4
What are the practical implications of Pre-registration? p. 5
What substances can be pre-registered? p. 5
Who can pre-register? p. 7
What information is to be submitted in pre-registration? p. 8
What happens if I do not pre-register? p.10
What do I need to consider before I pre-register? p. 11
2. Preparation for (pre-) SIEFp. 13
Preparation for pre-SIEF p. 13
Preparation for SIEF p. 14
How can data quality be established? p. 15
How can cost of data be evaluated? p.15
How is data to be summarized? p. 17
3. Application of Competition Law to REACH activitiesp. 18
Does competition law apply to REACH Activities? p. 18
Where could I find guidance on the way to comply with EC Competition law for my REACH activities? p.18
4. Preparation for collaboration p. 19
What is a consortium?p. 19
How and when is a consortium formed? p. 19
What to do when forming a consortium? p. 19
Signature of a pre-consortium agreement and/or a consortium agreement p. 20
Typical clauses that may be included in a consortium agreement p. 20
Elements of co-operation that may be included in a consortium p. 20
How to find out which consortia are already formed? p. 20
What are the categories of participants in a consortium?p. 21
Models of consortium agreementsp. 21
5. How to submit a pre-registration p. 22
How to choose the correct Pre-registration route? p. 23
How does bulk pre-registration work? p. 24
What happens once I have pre-registered? p. 25
How do I pre-register without an EINECS or NLP number? p. 25
How do I pre-register multi-constituent substances? p. 25
Is there another route to pre-registration?p. 26
Will there be a pre-registration number? p. 26
Can I change my pre-registration if a mistake is made? p. 26
6. Definitions and Further Information p. 27


Pre-registration Guidance (overview)

1. Preparation for pre-registration


What is pre-registration and why is it important?

Pre-registration is the means by which potential EU registrants including European Economic Area (EEA) manufacturers and importers of phase-in substances above 1 tonne per year[1], inform the European Chemicals Agency (ECHA) of their intent to register. Pre-registration via the ECHA’s REACH IT system is without a fee and will be of benefit to potential registrants in the following ways:

  • Benefit from extended timelines in which potential registrants can prepare for and submit their registration dossiers without interruption of manufacturing or importing. This provides additional time to organise the collection, sharing and assessment of available data and the collective generation of missing information;
  • Receipt of information regarding all other pre-registrants of the substance to enable them to start the process of verifying substance sameness and form a Substance Information Exchange Forum (SIEF). The purpose of this forum is to share data, thereby avoiding duplication of studies in particular vertebrate animal testing, to submit testing proposals for more advanced tests, to agree on classification and labeling and to work together towards registration.

Pre-registration, which takes place in the six-month period from 1st June 2008 to 1st December 2008 inclusive, is not a legal requirement under REACH. However, the manufacture and importation of a phase-in substance without pre-registration or without immediate registration is in breach of the REACH regulation.

It is not mandatory to register following pre-registration, if for example, the manufacture or importation is stopped prior to the registration deadline.

Further Information: See “What happens if I do not Pre-register?”

What are the practical implications of Pre-registration?

The result of pre-registration is to place automatically the pre-registrant into a virtual group of pre-registrants of a substance with the same EINECS number or other same identifier, called a pre-SIEF. Potential registrants in the pre-SIEF shall work together; and are lead by the SIEF facilitator (if available), to understand whether they intend to register the same substance. Once this has been agreed a SIEF is formed and its members will decide upon the substance classification and labeling and share data required for registration.

Within both pre-SIEF and SIEF, potential registrants and data holders are obliged to respond to relevant questions from other potential registrants. Data Holders, however, are not entitled to request data. In pre-SIEF the relevant questions are regarding substance identity. Questions on substance physical chemical properties, toxicology, eco-toxicology and classification might be relevant only in the SIEF when the potential registrants have decided on substance identity. The successful progress of potential registrants through these initial stages will require a pragmatic focus on the end point of registration.

According to the REACH Regulation, the SIEF will exist until 1 June 2018 and companies may need to actively participate in the SIEF activities. ECHA will decide on any remaining testing proposals until 1st June 2022.

Further Information: See “Preparation for pre-SIEF“ and “ECHA Guidance on Data Sharing“

Information on other pre-SIEF members will be listed in a closed ECHA webpage to which you will have automatic access following pre-registration. This webpage can be seen by:

  • Potential registrants of that substance;
  • Potential registrants of the substance(s) listed at pre-registration as candidate(s) for read across;
  • ECHA and national authorities.

This webpage will be updated every time a new potential registrant pre-registers the same substance and all members of the pre-SIEF will receive a message indicating the webpage updates unless they deactivated this option at pre-registration.

The ECHA will separately publish the following information on its open website by January 1st 2009:

  • Names of all pre-registered substances including Chemical Abstracts Service (CAS) numbers, European Inventory of Existing Commercial Chemical Substances (EINECS) numbers and other identity codes;
  • The first envisaged registration deadlines;
  • Substances intended to be used for read-across approach, Qualitative or Quantitative structure-activity relationship (QSAR) and grouping.

Pre-registrant company names will not be published on this open website.

What substances can be pre-registered?

Only phase-in substances that meet any of the following criteria can be pre-registered:

  • Listed in EINECS;
  • Manufactured in the EU (not necessarily exceeding the amount of 1 tonne per year), but not placed on the market in the EU by the pre-registrant in the 15 years before 1st June 2007 (e.g. intermediates, R&D substances);
  • "No-Longer Polymers (NLP)" and placed on the market before entry into force of REACH (1st June 2007).

All other substances are non-phase-in substances and cannot be pre-registered and shall be registered directly, preceded by an inquiry to ECHA. All chemical substances that have been previously notified in the EU under the Directive 67/548/EC are considered as being registered under REACH according to the original tonnage band they were registered for. A registration number will be assigned to the notification of these substances by December 1st 2008. Therefore pre-registration is not applicable for the legal entities which have notified these substances. This is summarised in Figure 1 (below).


Figure 1. Decision tree for pre-registration for phase-in substances

A company’s inventory of substances to be pre-registered should contain all substances (except those exempted, see below) that it wants to continue manufacturing/importing in amounts > 1 tonne per year. It may also contain strategically/critically-determined substances at the discretion of the company.

Further Information: See “What do I need to consider before I pre-register?”

It is strongly recommended to pre-register at least your currently manufactured or imported phase-in substances above 1 tonne per year in order to avoid possible compliance issues.

You need not pre-register substances that you source from EU suppliers, because the EU manufacturer or importer shall register them to continue manufacture / import, (no data no market). To ensure continuity of supply, it is advised to seek confirmation from the EU supplier that they will (pre-) register their substances.

Pre-registration, and indeed registration, is for substances only and not for preparations (blends or mixtures) or articles. The component phase-in substances of a preparation imported above 1 tonne per year need to be pre-registered to benefit from the extended deadlines. The same applies to substances that are intended to be released from articles.

Further Information: For the (pre-) registration and notification obligation of substances in articles, see Article 7 of the REACH Regulation or ECHA’s Guidance on requirements for substances in articles (to be published).

Substances that are exempted from registration need not be pre-registered. However, it is advised to consider substances below 1 tonne per year per legal entity depending on manufacture/ importation volume forecasts.

Consult Articles 2 and 9 and Annex IV and V of the REACH Regulation for the complete list of substances exempted from registration (Annexes subject to revision).

The list presented below is not exhaustive list, but provides some examples of exemptions:

  • All substances manufactured or imported below 1 tonne per year (note that registration may be exempted, but classification and labeling obligations still apply);
  • Polymers (note that polymerised monomers ≥2 wt.% and above 1 tonne per year and any other used substances chemically bound to polymers should be registered – refer to the ECHA’s Guidance for monomers and polymers);
  • Any additive to preserve the stability of the substance are part of the substance and need not be (pre-) registered separately unless they are manufactured separately in quantities > 1 tonne per year;
  • Impurities are part of the substance and need not be (pre-) registered separately;
  • Waste as defined in Directive 2006/12/EC;
  • Substances mentioned in Annex IV (subject to review) of the REACH regulation;
  • Substance exempted from the obligation to register according to Annex V (subject to review) of the REACH regulation.

The foreseen publication date of the revised Annexes IV and V of the REACH Regulation (exemptions from registration) is September/October 2008. After this date one may determine whether substances currently considered being included in these Annexes, are actually excluded and can be pre-registered before 1 December 2008.

The revised Annexes IV and V will be published by ECHA on their website.

Who can pre-register?

Any potential registrant can pre-register a phase-in substance. A potential registrant can be represented by a natural or legal person within the EU: an EU Manufacturer, EU Importer, only representative (OR), an EU importer or producer of articles that contain substances that are intentionally released, or any natural or legal EU entity which intends to manufacture and / or import a substance, produce and / or import articles that contain substances that are intentionally released or to become an OR.

If you are a legal entity inside the EEA ( from mid 2008, EEA countries Norway, Iceland and Lichternstein will also apply REACH) that would like to continue import of substances from outside the EEA, you are required to register. Import is the physical introduction of substance into the CustomTerritory of the European Community. The scope of the CustomsTerritory of the Community is defined in the relevant Community legislation on customs that should be consulted for further information (Council Regulation EEC No 2913/92 of 12 Oct 1992 establishing the Community Customs Code). The obligation to register, and therefore entitlement to pre-register lies with the EU-based legal entity that is responsiblefor the import of substance into the European Community. The obligations of an importer linked to imports such as the transfer of ownership, cost, freight/transport, insurance and customs duty (INCOTERMS) and the role in REACH do not have a direct link to the determination of the role as importer under REACH.

However, an EU-based importer of substances into the EU may not need to (pre-) register (but is not precluded from doing so) if one or both of the following applies:

  • The non-EU supplier has appointed an OR to take on the REACH registration and other REACH-related obligations of the EU importer(s). In this case the importer is considered a Downstream User under REACH and does not need to (pre-) register. If the importer does not wish to become a Downstream User, he will have to do his own pre-registration and registration for his imports;
  • The same substances are registered by an EU manufacturer, subsequently exported outside the EU and re-imported into the EU by the same actor or by an actor of the same supply chain and information in accordance with Art. 31 and Art. 32 related to the exported substance has been supplied.

Role of the Only Representative (OR)

Manufacturers and importers of substances outside the EU (e.g. Switzerland) cannot (pre-) register. Legal entities based outside the EU who export substances to the EU also cannot (pre-) register themselves, however those which are manufacturers,formulators or article producers (but not distributors) may chose to appoint an OR legal entity based in the EU to take on the REACH obligations of EU importers. An OR is a natural or legal person located in the EU territory having sufficient knowledge and expertise on the substances (e.g. handling).

When a non-EU supplier appoints an OR he should inform his customers in writing. As a result of this, his customers in the EU community are regarded as Downstream Users under REACH and therefore do not have to (pre) - register that given substance, but have still the obligations of a Downstream User. The OR shall keep information available and up-to-date on quantities imported and EU customers, together with information on the supply of the latest update of the safety data sheet.

The European Commission announced speaking at the joint Commission/European Chemicals Agency (ECHA) pre-registration launch in Brussels on April 14, 2008 that the only representative must submit a separate registration for each “non-Community manufacturer” he represents whereby he can represent one or several “non-Community manufacturers”. As the only representative is fulfilling the registration obligations of importers, the tonnage of the

substance to be registered in each registration is the total of the tonnages of the same substance covered by the contractual agreements with him and the specific “non-Community manufacturer” represented by him. The information requirement for the registration dossier shall be determined according to this tonnage. By making separate submissions, the confidential business information of the “non-Community manufacturer” can be preserved

and equal treatment with EU manufacturers can be ensured (EU manufacturers must submit separate registration dossiers for each legal entity). An updated Guidance on registration was published on May 27 2008 on ECHA’s website. Further updates of the guidance are planned after a more complete review of the issue of the OR.

When an only OR represents several non-EU manufacturers for the same substance, the OR shall submit one pre-registration per non-EU manufacturer represented. This requires that the OR signs up in REACH-IT as many times as pre-registrations for that substance. It is also recommended to add the OR appointment letter in the IUCLID dossier (section 1.7) of each registration.

The recommended approach is to ask your non-EU supplier(s) what his REACH intentions will be for the substance you import. If the non-EU supplier has appointed an OR and you do not intend to register as an importer it is mandatory to obtain a written statement from the non-EU supplier. A template questionnaire for this communication is provided on page 6 (Part I) of the Cefic REACH Industry Preparation Letter number 5. It is also advisable to obtain information regarding whether an OR has been appointed and has pre-registered well before the end of the pre-registration period (1st December 2008). If no OR has been appointed, or the OR has not pre-registered, you are required to register and would therefore need time to pre-register before December 1 2008. Alternatively you may register your substance immediately taking into account possible interruption of import activities.

It is recommended to ask your non-EU supplier what his REACH intentions will be for the substance you import.

In case your EU suppliers indicate that they will not (pre)-register their substance(s), an alternative supplier or alternative substances may be sought. A Downstream User may choose to pre-register and therefore become a potential registrant, if for example there is no indication that his suppliers will (pre-) register and no other alternatives exist. Article 28 (5) of the REACH regulationindicates that the ECHA may on request support the Downstream Users efforts to find a supplier.