Registration & Substance Identification

Are you Ready for REACH? We are.

Registration & Substance Identification

Bob Warner

REACHReady Consultant

[email protected]


RIP 3.1: Aim• …to assist industry in determining which tasks and

obligations have to be complied with to fulfil their registration* requirements under REACH….

• Includes advice on the special cases of:– Intermediates,– Polymers and – Product and Process Oriented Research and

Development (PPORD)

*NB – Registration not pre-registration


RIP 3.1 – Registration Guidance

• Product is four documents:

– Guidance on Registration

– Guidance on Intermediates

– Guidance for monomers and polymers

– Guidance for PPORD


Registration Guidance –strengths and weaknesses

• Very good overview and introductions to detail

• Clear advice on some common difficulties

• Some important problems not clarified

• Acceptance that further work needed


Using the Guidance

• Start with Guide on Registration

• Drill down using separate documents

• Use edit / find

• Have Regulation to hand

• Remember it’s EU law


• Published June 2007• Available on

REACHReady and ECHA website

• 106 pages• Similar documents on

Intermediates, PPORD and Polymers

RIP 3.1: Guidance on registration


Guidance on Registration

• Who has to register– Actors in the supply chain, Legal entities, only representatives

• What to register– Scope, volume calculation, Substances exempt from REACH, substances

exempt from registration, substances regarded as registered, Polymers, Recycled or recovered substances,

• When to register– Phase in status

• Data Sharing• Other duties of registrants

– SDS & information to customers

• Updating registrations, Appeals, Fees, Duties of the Agency


Who has to register:

• M/I of a substance – the legal entity responsible for the action

• No concessions for complex corporations (but…)

• Importers remain difficult to define

• Only representative to relieve burden on importers

Are you Ready for REACH? We are.Only Representative

Clear that:

• Appointed by non EU firm• Can represent several non EU firms• Represents manufacturers & formulators (but not overseas

“downstream”)

Less clear:

• Can exist in parallel to importers• What competencies are needed


Non-EU

Manufacturer

Non-EU

Manufacturer

Non-EU

Manufacturer

Only

Representative

Different opinions….

Current understanding is that tonnage does not need to be aggregated, instead multiple registrations must be submitted by the only representative

Only Representative for several manufacturers


Biocide and pesticide preparations - non actives• Art 15 very confusing – implies all ingredients may be

regarded as registered

• Guidance clarifies – notes that Art 15 can only apply to actives

• Guidance clearly states non actives must be registered


Medicines (human and animal)

Key test:

• What is registered as a medicine? All substances in the medicine exempt from registration

• Registration needed for other uses (unless also exempt)


Recycling and recovery

• Comprehensive list of examples

• Conditional on already registered and information

• Many by products may need registration by manufacturer

• Wastes not in scope – no useful purpose


Volume calculations

• (Pre registration – no advice – use justifiable business estimates)

• Phase in – average of past 3 years on rolling basis, may need to B/F full registration

• Non phase in – estimate of proposed annual production


Isolated intermediates

• Reduced Registration requirements if ‘strictly controlled’

• Advice on strict control – relies on registrant’s declaration

• Differences expected in MS CAs use of advice and declaration

• When to register? Available information?


Polymers

• Good examples in long winded Guidance

• Polymers have a specific definition in the REACH Regulation

• Defined polymers are (temporarily) exempt from Registration

• M/I of polymer may instead be required to register the monomers and other substances used for the manufacture of the polymer


Polymers – problem areas

• Exact status of polymers notified under NONS and where monomers not notified or registered

• Threat of registration in the future

• Practical problems on importation

• Legal challenge pending – disproportionate claim


Polymers as preparations

• There may be several polymers and substances in a preparation - each must be registered appropriately

• Stabilisers difficult - advice unusually generous, but take care!

• Graded pellets are probably not articles


• Published June 2007• Available on

REACHReady and ECHA website

• 117 pages

RIP 3.10: Guidance for identification and naming of substances under REACH


RIP 3.10: Objectives

…guidance for manufacturers and importers on recording the identity of a substance.

. ….how to name the substance. …

….guidance on if substances may be regarded as the same for …REACH


RIP 3.10 not for…..

• Defining groups for structure activity and similar read across methods

• Absolute comparisons for data sharing

• Although may be useful for both..


Strengths and weaknesses

• Excellent read – clear and accessible

• Softest Guidance, pragmatic and flexible

• Explains how to identify and define substances

• Emphasis on carbon chemistry? Thin on minerals, inorganic, special cases?


Registration for manufactured substance

• When does manufacture end in a multi stage process??

• Isolation of a product?

• Guide – “Case by case decision”

• But…..


Registration for manufactured substance

• May need to register product which not marketed

• Subsequent separation of constituents may require second registration stage

• But no testing may be required for first product

• Cost? Effort? Tonnages?


Pre registration

• Broad description (Art 28)

• Bringing together of potentially common registrants

• Check on sameness (may need more guidance)

• Assembly of same substance SIEFs

• Full registration detailed identification (Annex IV)


Substances can be…

• Mono constituent (80/20 rule guide)

• Multi constituent – reaction mass / mixtures

• Unknown / variable composition

• Complex reaction products

• Biological materials

Are you Ready for REACH? We are.Single or multi constituent

• Substance A

mono-constituent 80/20

(substance A + impurities x,y,z)

• Substance C

multi-constituent <80 >10

(reaction product of A + B = X + Y)


UVCB (unknown or variable composition, complex reaction

products, biological materials)

•Identification requires source and process descriptions of sufficient detail

•Examples in Guide

•More case by case – industry based solutions?


Where to find out more:

Final RIP 3.1 & 3.10 available to download as PDFs

from websites at:

http://www.reachready.co.uk

http://reach.jrc.it/guidance_en.htm#GD_PROCC_I


Thanks for listening…..

..and let REACHReady help you…..

Bob Warner

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Registration & Substance Identification

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