Wednesday, June 25, 2008 |
Joseph S. Tomusange, REACH coordinator, Treatt plc
With first pre-registration fast approaching, manufacturers and suppliers of chemical substances are bracing themselves for the impact of REACH - the new chemical regulation introduced by the European Union.
Described in some quarters as possibly the most complex set of regulations issued by an international organisation, REACH may appear to be a minefield for those it affects. With so many factors to consider, the challenge for companies is gaining a thorough understanding of the implications that REACH will have on their business activities.
Here, Treatt provides a step-by-step guide on the scope of REACH regulation. The company offers insights from an EU-based company's perspective, presents key considerations and helpful hints to get prepared for REACH. It demonstrates that with careful planning and preparation, REACH is not the daunting task it may seem.
REACH explained
REACH - the Registration, Evaluation, and Authorisation
(and Restriction) of Chemicals - is the new European Union
regulation which came into force on 1 June 2007. It
replaces a number of European directives and regulations
with a single system. It will apply to European chemical
companies who manufacture and/or import chemicals
substances into the EU in quantities of more than one tonne
per legal entity.
The new regulation aims to generate data on the effects of chemical substances so that they may be used safely. Manufacturers and importers who place chemicals on the market will now be responsible for understanding and managing the risks associated with their use. This should result in a more innovative and competitive European chemical industry that also encourages the substitution of toxic chemicals with safer alternatives.
The key element of REACH regulation is the requirement for manufacturers or importers of chemicals to register them with the European Chemicals Agency (ECHA). A registration dossier will be supported by a standard data set on that substance. However, the data requirement for each substance will be dependent on the amount that is manufactured or supplied and the toxicity of the substance. So, the largest volume and most toxic substances will require the most data for their registration dossiers. If chemicals are not pre-registered and then registered; then there will no longer be able to market the substance.
Breadth of REACH
It cannot be denied that REACH regulation is extremely
complex. A huge number of substances used in the flavour
and fragrance industry will be affected by the new
regulation. These include fragrance ingredients (eg aroma
chemicals, essential oils and natural extracts), flavours
in oral care products (eg mint oils), flavours in tobacco
and isolated intermediates. There are some exclusions -
substances deemed generally safe (eg water, corn oil),
preparations (mixtures of substances / blends), flavour and
food ingredients and additives, pharmaceutical ingredients
and nonisolated intermediates. Essential oils and natural
extracts are only included if they are used as flavour or
fragrance ingredients in cosmetics.
D-days
With estimates showing around 30,000 substances supplied in
quantities of one tonne or more per year on the European
market, registering these items presents a significant
challenge. To facilitate the process, the first phase is a
pre-registration phase which provides companies with a six
month window (from 1 June until 1 December 2008) to submit
a limited amount of data to the ECHA. By submitting data
within this period, companies will be able to benefit from
the staggered registration periods set in REACH for
phase-in substances.
The pre-registration phase is also in place to allow companies that manufacture or import the same substances to form groups or SIEF (substance information exchange forums) where data is shared to avoid duplication during the registration process.
Here, participants must agree on the classification and labelling of their substances. They must provide other participants with existing research, respond to information requests and collectively identify the need for future studies and arrange for them to be carried out. This is followed by registration, where manufacturers and importers submit information dossiers on substances to the ECHA. Registration is based on two parameters: quantity and toxicity. The timeframe for the process from pre-registration to the final phases of registration is a decade.
These initial deadlines have been set to ensure the most frequently-used and most toxic substances are assessed in the first phase. The substances and dossiers are then evaluated by the ECHA to confirm reliability of all submitted data and authorised for specified use. To place substances with properties that are deemed to be of "very high concern" on the market, an authorisation process must be applied for by 1 June 2009. A company wishing to market or use such a substance must submit an application to the ECHA. Authorisation is then decided by the European authorities.
Getting ready for REACH
Once the full scope of REACH has been understood, it is
essential to assess the implications for product
portfolios. A key consideration will be the potential need
for reformulation - some substances may become unavailable
if suppliers are unable to comply with the regulation.
Treatt's range of products, for example, can be divided into three groups: essential oils and extracts, aroma chemicals and blends (or preparations as they are described in REACH). Each will be treated differently under REACH regulation.
Essential oils and extracts
By far the most complicated category, essential oils and
extracts are referred to as Natural Complex Substances
(NCS) within the industry or Substances of Unknown or
Variable composition (UVCBs) under REACH. Many of these
substances are imported into the EU in quantities greater
than one tonne per year. The challenge for this category is
that many of these substances have been used for hundreds
of years, and as a result are generally recognised as safe.
This means that the necessary test data has never been
generated. Therefore, many companies possess the
physicochemical data but lack testing facilities to produce
the required human and environmental exposure data. The
European Flavour & Fragrance Association and the European
Federation of Essential Oils have formulated a plan to
assist the industry in preparing for the registration of
Natural Complex Substances. This is primarily through the
formation of pre-consortia which pre-empt the substance
information exchange forum described in the regulation. For
the highest priority aroma chemicals and naturals, namely
those requiring registration in 2010, this process has
already started.
Aroma chemicals
Aroma chemicals can be considered 'well defined substances'
- substances with a defined qualitative and quantitative
composition that can be sufficiently identified based on
the required identification parameters. Initial assessments
have indicated that for importers and distributors of these
substances, like Treatt, much of the required data is
already available or will become available through data
sharing.
However, assessment of volumes and supply lines will be necessary to determine which substances importers will need to register.
Preparations or blends
Although preparations or blends do not need to be
registered under REACH, companies must record the
substances in these preparations which are present in
quantities greater than one tonne per year.
Implications for the supply chain
The impact of REACH will be felt throughout the supply
chain. From raw material suppliers to end product
manufacturers, everyone will be affected by the new
regulation. Suppliers in the EU, for example, will now be
assessed differently to those outside the EU who have no
registration obligations. Suppliers outside the EU cannot
register for REACH directly. They can, however, opt to
nominate an 'only representative' - an EU-based
representative of a non-EU manufacturer. Appointing an
'only representative', allows manufacturers to participate
in the REACH process and ensures that they will be able to
market their product directly in the EU. It also has
advantages for EU importers. They are spared the task of
registering the product under REACH and will be regarded as
a downstream user.
Throughout the REACH process, customer needs should remain paramount. To maintain optimum customer service, Treatt, for example, has appointed a dedicated co-ordinator for REACH-related matters to respond to all customer and supplier queries. This contact is an in-house expert on the regulations, providing support to the technical, sales and purchasing teams on REACH-related matters, and assisting senior management in developing a company action plan.
The three Cs
Those affected by REACH should consider the three Cs when
implementing an action plan - communication,
confidentiality and costs. Communication is key.
REACH preparation will rely on effective communication
between sales, purchasing and regulatory departments. It
will involve extensive training, data collection and
migration. The finance department will also need to ensure
sufficient funds are in place for testing, compensation of
existing data holders and the registration process.
Secondly, confidentiality will be an issue with so much dialogue between different members of the supply chain. According to REACH, any details that undermine commercial interests will not be passed on but information relating to safety will never be confidential.
Finally, the costs of compliance will be significant. The authorities are making concessions mindful of the number of SMEs that will be affected. However, there will be financial implications at every stage of REACH that must be considered carefully.
Some of these costs may have to be passed along the supply chain, making it essential to keep abreast of any product margin developments that are business critical.
Summary
There is no doubt that REACH will have a huge impact on the
European chemical industry. In fact, it has already had a
huge affect on the flavour and fragrance industry; many
competitors are finding ways to work together to reach a
common goal.
However, despite its challenges, the regulation will offer significant benefits, improving safety and preserving the environment. With careful and advanced preparation, companies can ensure they comply with REACH and continue to run their business effectively and efficiently.
ENDS
Editor's note:
Treatt plc is a world-leading independent ingredients
supplier to the flavour and fragrance industries. It
manufactures and supplies a vast inventory of innovative
products, including essential oils and their natural
fractions, and aromatic chemicals.
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