European manufacturers and importers of chemicals have been
told they will not be unduly burdened by the third and final
phase of substance registration under REACH, the regulation
that covers chemical usage within the EU.
REACH, which abbreviates the EU’s Regulation on
Registration, Evaluation, Authorisation and Restriction of
Chemicals, entered into force on 1 June 2007. Phase three of
REACH requires all chemicals made or imported into the EU in
quantities of 1 tonne per year or more to be registered by a
deadline of 1 June 2018. This tightens up on the requirements
of the two previous phases.
Phase one carried a 1 December 2010 deadline for
registration of chemicals in volumes greater than 1,000, 100
and 1 tonnes per year, depending on hazard classification.
Phase two, the deadline for which fell on 1 June 2013, covered
all chemicals in volumes of or above 100 tonnes per year.
According to experts at the European Chemicals Agency
(ECHA), the body which evaluates registrations for compliance,
even though the third REACH deadline will apply to much smaller
businesses than earlier phases (referred to as small and medium
enterprises, or SMEs), the legislation is not designed to be
onerous and has been introduced with acute sensitivity to the
needs of the chemicals industry.
"REACH is not at all new," notes Kevin Pollard, head of
dossier submission at the ECHA. "It has been a long-term
exercise; the regulation came into force in 2007, but the
initial proposal for REACH was back in 2000 and was followed by
a seven year period of comment on the text of the
legislation."
Chemicals are vital to a huge range of European industries,
from steelmaking to cosmetics. But many consumers are oblivious
to the substances that they come into contact with every day.
Bromine compounds, for example, are added to the plastic
casings of televisions, laptops and mobile phones to make them
flame retardant; sodium carbonate, commonly referred to as soda
ash, is used to make glass bottles and laundry detergents; and
titanium dioxide (TiO2) is a white pigment found in
most types of household paint.
This direct but generally unconscious contact between humans
and chemical compounds was one of the key driving forces behind
the introduction of REACH.
"REACH is about understanding the hazards and uses of
substances and ways of managing the related risk to protect
human health and the environment," says Pollard. It also makes
businesses responsible for demonstrating safe use, replacing
the disjointed pre-REACH situation, which left assessment of
chemical hazards in the hands of national authorities.
The third registration deadline will by its nature affect
smaller companies operating in the EU and Pollard accepts that
some of these may not be "fully up to speed" with REACH
requirements.
Accordingly, businesses in this bracket have been given the
longest notice period to review their supply chains and adjust
to any extra expenses they may incur by complying with REACH.
The cost of registration can range from a few hundred euros for
small volume, non-hazardous chemicals (such as certain
commodity fertilisers, for example), to tens or even hundreds
of thousands of euros for large volume substances which may
have large data gaps in terms of hazard information.
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Extending its REACH:
Europe’s chemical producers are
preparing for the third and final phase of EU
chemicals
registration (pictured: BASF’s
headquarters in Ludwigshafen).
(Source: BASF)
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SVHCs
Once registered, chemicals may be subject to a separate
policy under REACH called authorisation. This applies to
substances of very high concern – or SVHCs. The
authorisation procedure aims to ensure that SVHCs –
classified as carcinogenic, mutagenic, toxic for reproduction,
and/or persistent, bioaccumulative and toxic – are
properly controlled and progressively replaced with suitable
alternatives.
SVHCs, once identified, are added to a candidate list before
being prioritised to an authorisation list. If a substance is
categorised as requiring authorisation, it cannot be placed on
the market or used after a given date, unless an authorisation
is granted for its specific use, or the use is exempted from
authorisation.
"Companies have to decide whether to phase out the SVHC by a
given deadline, or invest in developing a substitute," explains
Pollard. He points out that this hard line policy is balanced
by the early warning system entailed in the listing
process.
Specially tailored provisions for areas including human and
veterinary medicines, food additives, plant biocides and
substances specifically required for research and development
purposes have also been designed and implemented to
troubleshoot potential limits on key industries.
One recent notable example of a chemical that fell within
the SVHC remit is the brominated flame retardant chemical,
hexabromocyclododecane (HBCD). This was the standard flame
retardant used in expanded polystyrene (EPS) and extruded
polystyrene (XPS) insulation foams, but after being flagged as
a toxic substance following an EU risk assessment, HBCD was
placed on the candidate list of SVHCs requiring authorisation
in 2008.
In 2011, the chemical was included in Annex XIV of
substances for authorisation under REACH, with a "sunset" date
of 21 August 2015. After this date, only companies that have
applied for, and have been granted, authorisation can continue
to use HBCD for an agreed period.
In 2013, HBCD was included as persistent organic pollutant
(POP) in annex A of the UN Stockholm Convention on POPs with
exemptions for EPS and XPS in buildings. This means that
parties to the convention can request an extension of up to
five years for using HBCD in these applications.
The designation of HBCD as an SVHC spurred manufacturers of
the chemical to develop less harmful alternatives. Tel
Aviv-based Israel Chemicals Ltd (ICL), which operates a number
of chemical production operations in EU countries, created a
replacement flame retardant called FR-122P through its
specialist Industrial Products (IP) arm. According to the
company, the new chemical provides the same level of fire
protection as HBCD but with a "significantly improved"
environmental profile.
"ICL-IP produces FR-122P under a licence agreement signed by
Bromine Compounds Ltd (BCL), a business unit of ICL-IP, with
Dow Global Technologies in January 2012," explains Anantha
Desikan, vice president for flame retardants at ICL.
In August last year, ICL established a joint venture with US
bromine producer Albemarle Corp. to make ICL’s
FR-122P and Albemarle’s own polymeric alternative
to HBCD, known as GreenCrest, at manufacturing sites in Israel
(10,000 tpa) and the Netherlands (2,400 tpa).
Desikan says that the new chemical has been commercially
accepted by ICL’s customers and that both the
Israeli and Dutch plants are now fully operational.
"Based on feedback from the market, compacted material for
both EPS and XPS will be available in 2016. Both speciality
grades of the compacted polymeric FR products were developed in
accordance with application requirements, to optimise their
performance and flame retardant needs," notes Desikan.
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The classification of some chemicals as
SVHCs has spurred
the development of new substances with improved
environmental
profiles, however such R&D can be costly for
SMEs.
(Source: BASF)
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Counting the cost
Aside from protecting people and the environment from the
effects of hazardous chemicals, REACH registration aims to
allow free movement of approved substances within the EU market
and is intended to promote innovation and competitiveness.
These laudable goals notwithstanding, there have been fears
that the cost and administrative encumbrances associated with
registration could force some businesses to up sticks and
relocate their operations outside EU borders.
Pollard says that since REACH came into force in 2007, the
ECHA has not seen any strong evidence of companies choosing to
relocate in order to avoid registration. Ahead of the 2010
registration deadline, there were "quite a lot of politics"
around the concern that downstream consumers of chemicals would
leave the EU. "But," says Pollard, "that didn’t
happen."
Others are worried that the financial and bureaucratic
burdens of registering low volume substances will curb growth
in some business areas, particularly in the SME sector.
Tom Bowtell, CEO of the British Coatings Federation (BCF),
notes that REACH was "voted the most burdensome regulation in
the EU by SMEs", according to the results of a European
Commission poll conducted in 2012.
The BCF is one of a number of industry bodies working to
increase the visibility of how REACH will affect the
competitiveness of the chemicals and related industries in the
UK.
"The BCF welcomes the intentions behind REACH in eliminating
very hazardous substances, and appreciates that
ECHA’s 2018 deadline gives time for SMEs to
prepare," says Bowtell. "However, SMEs will find it almost
commercially impossible to recover the costs incurred by REACH
when registering substances between 1 and 5 tonnes, regardless
of the Phase 3 deadline."
Bowtell points out that many of the BCF’s
members impacted by REACH are those which work with niche, high
value applications in small quantities and that the regulation
will hamper advances in the sector. "REACH will stunt
innovation and growth opportunities for SMEs in Europe because
they cannot be sure of being able to obtain the chemicals they
want to."
ICL is more forbearing about the regulation’s
impact, although as a global company with the funding and
resources to facilitate compliance with REACH with relative
ease, this is perhaps not surprising. "In general, of course
REACH regulation has an effect on many aspects of operational
and supply activity in the EU and actions need to be taken to
ensure that only REACH-compliant products are being
manufactured or imported into the EU," says Desikan.
"For our FR-122P product, both production sources –
the EU and Israel – are in compliance with REACH
regulation. Being a polymeric product, FR-122P is exempt from
REACH and (…) the relevant raw monomers are REACH
registered."
For its part, the European Chemical Industry Council (CEFIC)
has conceded that the fallout from phase three registration
remains uncertain. "There are still quite a large number of
companies who haven’t really decided what they
intend to do – whether to register (…), or
remain just below the 1 tonne level," says Erwin Annys, the
CEFIC’s director of REACH/chemicals policy.
"At the end of the day, it is of course a purely commercial
decision-making process as to whether you can still make money
on these chemicals."