23/02/2018

REACH Regulations

REACH
• The REACH (Registration, Evaluation, Authorisation and restriction of
Chemicals) Regulation 2006 aims to:
– provide a high level of protection for human health and the environment;
– make manufacturers and importers responsible for managing risks;
– allow the free movement of substances on the EU market;
– enhance the competitiveness of the EU chemicals industry;
– promote alternative methods for the assessment of hazards.
• The Regulation:
– requires manufacturers and importers of chemical substances to gather
hazard information and assess risks;
– can require the use of some particularly high-risk substances to be authorised;
– restricts the marketing and use of certain hazardous chemicals and mixtures.

The Process
• A substance of very high concern SVHC is
identified either by ECHA European Chemical
Agency or by a member state
• It then goes on to a candidate list of
substances
• Can be moved to the authorisation list but this
requires a risk assessment to be carried out.
• SVHC identification process includes a period
of public consultation of 45 days.

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The Process
• Risks from a SVHC are controlled and the
substance can be progressively replaced
• Substances that are identified are those that
are:
– Carcinogenic, mutagenic or toxic for reproduction
– Persistent, bio-accumulative or very persistent and
bio-accumulative

The Process
• These substances cannot be placed on the
market or used after a given date unless an
authorisation is granted for their specific use –
or the use is exempted from authorisation.

The Process
• The Candidate List:
– Identifies substances that may have serious effects
on human health (either by ECHA or member
state)
– This places legal obligations on companies
manufacturing, importing or using the substance
– Information is made public in the registry of
intentions

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The Process
• Candidate List;
– The proposal contains:
• Data and justification for the identification as an SHVC
• Volumes and release, resulting exposure and possible
alternatives
– Proposal is released for comment
– No comments substance is put on the candidate
list
– No agreement the matter goes to the EU

The Process
• Authorisation (moving from the candidate list
to the authorised list)
– Made at the recommendation of ECHA
– Information included in the recommendation
includes:
• Sunset data – date from which placing on the market
and use of the substance is prohibited
• Latest application date – by which applications must be
received if an applicant wishes to continue using the
substance

The Process
– Information:
• Review uses for certain substances if any
• Exempted uses

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The Process
• Applications for Authorisation:
– Once a substance is on the authorised list then
manufacturers, importers or downstream users
can apply for an authorisation
– They need to show that:
• The risk from the use of the substance is adequately
controlled.
• OR that the socioeconomic benefits outweigh the risks
and that there is no suitable alternative

The Process
• The application needs to include:
– Chemical safety report
– Analysis of possible alternatives
– Plan to substitute
– Socio-economic analysis

The Process
• Once the application (and the fee) is received:
– ECHAs risk assessment committee (RAC) and the
Committee for socio-economic analysis (SEAC)
prepare their opinion
– Public consultation period
– RAC & SEAC draft opinions after 10 months
– Opinions sent to the EU and a decision is made on
authorisation

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The Process
• If authorised the holder:
– Must include the authorisation number on the label of
the substance or any mixtures containing the
substance
– Downstream users of the substance must also comply
with the authorisation and inform ECHA of the use of
the substance
– ECHA keeps a register of the notifications and informs
the competent authority in the member state
– A review period is stated – review report must be
submitted at least 18 months before the review
period ends.

The Process
• REACH restrictions:
– Restrictions limit or ban the manufacture, placing
on the market or use of certain substances that
pose an unacceptable risk to the environment or
human health.
– A member state or ECHA can propose a
restriction.

REACH information
• Candidate List - https://echa.europa.eu/candidate-list-table

• Registry of Intentions - https://echa.europa.eu/registry-of-

submitted-harmonised-classification-and-labelling-intentions

• Substances restricted under REACH. List available at:

https://echa.europa.eu/substances-restricted-under-reach
• Conditions set for instance the use of benzene.

• Current Activities on Restriction https://echa.europa.eu/current-

activites-on-restrictions

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REACH
• Most businesses will be affected by REACH in some
way.
• REACH affects any business of any size that:
– manufactures chemical substances
– imports chemical substances
– distributes chemical substances
– sells chemical substances
– uses chemical substances

REACH
• Registration:
– Data on substances provided by manufacturers
and importers to the EU authorities (European
Chemical Agency – EUCHA).
– All substances manufactured and imported above
1 tonne per year
– Competent authority HSE & EA
– http://www.hse.gov.uk/reach/about.htm

REACH & Brexit

• UK could still adopt REACH
• UK could adopt a modified version of REACH
• ??

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REACH & PHTHALATES

• Those most commonly used – the high molecular
weight, were registered before the deadline of
30/11/10
• EU chemical bureau & experts in member states
agreed that high molecular weight do not need a
hazard classification and risk reduction is not
needed
• Not considered to be persistent or bio-
accumulative – so did not need to go on the
candidate list

PHTHALATES
• Range of chemicals used as plasticisers

REACH & PHTHALATES

• Low Molecular Weight:
– Placed onto the candidate list
– Authorised for use until Feb 2015 – manufacturers or users must
submit a dossier of information to continue using them after that date
– if agreement is reached they will move from the candidate list.
– EU manufacturers or importers of any substance containing more than
0.1% of these substances must notify ECHA – unless they have already
been registered for that specific use.
– Producer must inform everyone in the supply chain of their inclusion
in the product – distributors, retailers and professional end users.
– Information must be given to consumers if they request it.

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PHTHALATES
• Four key low molecular weight phthalates:
– Benzyl butyl phthalate (BBP)
– Di(2-ethylhexyl)phthalate (DEHP)
– Dibutyl phthalate (DBP)
– Diisobutyl phthalate (DIPB)

PHTHALATES
• 2011 Danish competent authority made a
restriction proposal - to limit human exposure
from these four phthalates in consumer articles
• 2012 Committee for Risk Assessment (RAC) –
current data does not indicate a risk from
combined exposure to the four phthalates
• Existing regulatory measures and reduced use
would reduce exposure
• Proposed restriction not justified

PHTHALATES
• SEAC – committee for socio-economic analysis
(part of ECHA) noted a steady decline in use
• In terms of uncertainties RAC recommended
bio-monitoring and following trends data.

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Nanomaterials
• Chemical substances or materials manufactured or used on a
very small scale
• Nanoparticles – 1- 100 nm
• Properties may differ from the same substance in bulk
amounts
• Products containing nanomaterials include:
– Batteries
– Coatings
– Anti-bacterial clothing
– Cosmetics
– Food products

Nanomaterials
• Rapid increase in use noted by ECHA
• There may be the potential for health effects
• Focus of research by ECHA