Ref. Ares(2014)78294 - 15/01/2014

European Commission(Pre-)registration: Basics

REACH: Final countdown
to pre-registration and registration
Brussels - 14 April 2008
Otto Linher, European Commission, DG ENTR, REACH Unit

4/15/2008

1

Who has to (pre-)register (1)?
Manufacturers of substances and producers
of articles with intended release:
Each legal entity (national definition) must register
separately

May appoint Third Party Representative¾ allows keeping identity confidential within SIEF
¾ manufacturer remains liable for registration

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2Who has to (pre-)register (2)?
ImportersSame obligations and rights as EU-manufacturers (includingright to appoint a Third Party representative)

However, non-EU manufacturer may appoint Only
Representative insteadIn such cases, Only Representatives is liable for registrationand importer is considered as downstream userOnly Representative must submit a separate (pre-)registration for every non-EU manufacturer he represents¾ Note that this is a change from earlier interpretation!

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3

What to (pre-)register (1)?
All substances manufactured in quantities ≥ 1tonne/yr
 Phase in substances (“existing substances”):– Listed in EINECS– Manufactured in the EU but not placed on the market in the EU
between 1992 and 2007
– “No-longer polymers”¾ Staggered deadlines if pre-registered Non-phase in substances (all other substances)¾ Registration before first manufacture or placing on themarket

 Except: Substances used in food, medicine,radioactive substances, waste, substances listed inAnnex IV and V etc.
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4Types of substances (1)Substances of well definedcomposition:
Mono-constituent substances¾ as a rule of thumb substances in which one main

constituent is present to at least 80% w/w (“80% rule”)

Multi-constituent substances¾ More than one constituent is present in a concentration of

10% w/w or more and 80% or less (“<80%/>10% rule”)

Ö4/15/2008

Impurities and additives necessary to preserve thestability of the substance do not have to be(pre-)registered separately but are part of thesubstance5Multi-constituent substances
vs. preparations (1)Multi-constituent substances¾ A multi-consituent substance is the result of a chemical

reaction in a manufacturing process (typically a reactor)¾ One registration (“reaction mass of <A> and <B> and...

<(constituents >10%>))¾ All multi-constituent substances are phase-in substances ifthey or their constituents are listed on EINECS (forpracticalities see REACH-IT)

Preparations¾ A preparation is gained by mixing two or more substances

without chemical reactions¾ Substances in preparations must be registered separately(if not already registered upstream in the supply chain)

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6

Multi-constituent substances
vs. preparations (2)Registration of individual constituentsof multi-constituent substances possible
but only under certain conditions:¾ there is no reduction in information requirements¾ there is no additional testing as a result¾ it leads to more efficient registration (i.e. avoidingnumerous registrations)Ö However, bear in mind that companies need toagree on substance identity all across Europe
Ö Going alone might violate data sharing obligations
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Types of substances (2)“UVCB” Substances: Substances of unknownor variable composition, complex reaction
products or biological materials:
Number of constituents is very large or undefinableComposition is to a significant part unknown

Large variability or poor predictability

Special naming convention for enzymes (IUBMBnomenclature)






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Examples:EC number
296-358-2
307-507-9
263-151-3

EC NameLavender, Lavandula hybrida, ext., acetylated
Lavender, Lavandula latifolia, ext., sulfurized, palladium salt
Fatty acids, coco, reaction products with diethylenetriamine8

What to (pre-)register (2)?
Special rules for:
Polymers¾ exempted from registration but monomers contained in them must

be registeredIntermediates¾ “lighter” registration (lower data requirements)¾ provided that substances are used under strictly controlledconditions

Product and process oriented research anddevelopment (PPORD)¾ Only notification required¾ Agency may impose conditions

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9

What is the “same” substance?


Many detailed questions answered in the guidance for
identification and naming of substances!

Be aware that substances may still be the same, even if

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Composition may vary (e.g. in multi-constituent substances)Impurities may vary (even if this results in different classificationand labelling)“Sameness” of substance to be decided by registrants in SIEF
formation processCompanies have a certain flexibility but provision may not be usedin an arbitrary way (violation of data sharing obligations)Key question: Does data sharing lead to a meaningful result for all
SIEF participants?

In case of disagreements on the selection of information opt-out orpartial opt-out of joint submission still possible
10What happens if companies do not pre-register? (1)Ö Pre-registration is not obligatory but...: In the absence of pre-registration, registration applies
from 1 June 2008 (even if companies still may pre-register until 1December 2008)

 Companies who do not pre-register have to interrupt
manufacture, placing on the market and use between
1 June until three weeks after completion ofregistration during: inquiry
 submission of registration
 completeness check by Agency

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What happens if companies do not pre-register? (2) Companies are still bound by joint submission anddata sharing obligations) If substance has not yet been pre-registered at the time ofinquiry:¾ participation in SIEF and data sharing is obligatory (as a data holder)) if substance has already been pre-registered or registered at
the time of inquiry¾ participation in SIEF and data sharing is obligatory¾ opt-out only possible if justified

Ö ...if you do not pre-register and (illegally) continue
manufacturing, placing on the market or using thesubstance, you put yourself and your clients at risk!
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12What happens after pre-registration?
1.
2.

3.
4.
5.
6.
7.

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Agency publishes list of pre-registered substances
Data holders (downstream users, universities, NGOsetc.) may indicate that they have relevant data on preregistered substances: they get special role in SIEFs
REACH-IT brings submitters of the same identifier
together: “Pre-SIEF”
Industry needs to agree on SIEF formation
Industry needs to share data within the SIEF
Industry needs to jointly submit data to Agency via
REACH-IT
Agency and Member States evaluate data13

Where to turn for help?
1.

Check the legislation (available in all EU languages)(http://eurlex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML)2.

Check the Guidance website (http://echa.europa.eu )3.

Check the Frequently Asked Questions on the ECHA website(http://echa.europa.eu )4.

Talk to your colleagues, business associations, industry
helpdesks

5.

Contact your national helpdesk (addresses can be found on
http://echa.europa.eu )4/15/200814

Further Information
http://echa.europa.eu
http://ec.europa.eu/enterprise/reach/index_en.htm
http://ec.europa.eu/comm/environment/chemicals/reach.htm
http://ecb.jrc.it/REACH/

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