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REACH strategies for management29th of October 2014
Writing exclusively for ECJ, Dr Sandra Meijer of The REACH Centre explores the impact of REACH on industry in practice and discusses strategies and best practice for REACH management.
Most industry sectors have by now managed to get to grips with REACH registration and many companies have successfully met the first two registration deadlines of Dec 2010 and June 2013.
However, there is more to REACH than just registration of chemicals, and effective management of REACH is needed in order to ensure compliance in the supply chain.
REACH continues to evolve and develop; therefore one of the big challenges in managing REACH is keeping up with changes. A substantial challenge is now placed on industry to actively and frequently monitor changing obligations relating to substances and processes introduced as a direct result of the regulation. Each one of these changes can impact on business continuity.
For example, authorisation is the protocol within REACH for identifying and controlling the use of Substances of Very High Concern (SVHCs), with the longer-term aim of finding alternatives. SVHCs are identified based on meeting one or more criteria:
• Class 1A or 1B CMR
• Persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) as defined under Annex III
• Of equivalent level of concern, eg, endocrine disrupters.
Such substances are placed on the Candidate List for Authorisation and may subsequently be placed on Annex XIV, the list of substances subject to authorisation. Annex XIV substances cannot be used in the EU after a designated ‘sunset date’ unless those companies have obtained an authorisation for their specific use(s).
With 31 substances already on the Annex XIV list and a further 33 proposed to be added, authorisation is affecting more and more industries. Furthermore, authorisation has potential impacts on all businesses along a supply chain. They not only face the risk that their supplier may remove their chemical substances from the market, but also that their use is not covered by an authorisation.
Dozens of SVHCs are identified every year and ECHA has a target of placing all known relevant SVHCs on the Candidate List by the year 2020. All could eventually be removed from the market.
The current list of SVHCs contains 22 solvents/degreasers, and 10 surfactants potentially used in industrial cleaning (for more information, see www.chemtrac.co.uk).
The other protocol within REACH for controlling certain uses of hazardous substances is the Restriction protocol (Annex XVII). Again, proposals for new restrictions are submitted on a very regular basis. An example of a recently proposed restrictions that could potentially affect the cleaning sector concerns N-methylpyrrolidone (NMP) in coatings and cleaners for professional uses.
Drivers for change
The identification of SVHCs and proposals for new restrictions are to a large extent based on hazard. Whilst the registration of substances is meant to generate better data to support hazard assessment, sometimes the authorities need extra information to decide whether or not substances need additional controls. This leads us to the Evaluation protocol of REACH.
Within REACH, substances are evaluated under the Community Rolling Action Plan (CoRAP) by the Member States (MS). The aim is to clarify whether their use poses a risk to human health or the environment and MS can request further information from the registrants of the substance to verify the suspected concern.
Unless it is concluded that the risks are sufficiently controlled with current measures, evaluation will generally lead to the MS submitting a proposal for either a restriction, listing as an SVHC, or harmonised classification. There are 120 substances included in the CoRAP list for 2014-2016 and the list is updated annually.
Harmonised classifications are listed on Annex VI of the Classification, Labelling & Packaging (CLP) Regulation. Although this is not part of REACH, the impact of harmonised classifications on REACH obligations is extensive. For example, substances currently lined up for 2018 registration could suddenly become subject to immediate registration when their classification is updated to CMR Category 1A or 1B status.
In summary, evaluation can lead to substances becoming restricted, subject to authorisation, or being re-classified. Re-classification itself can then further lead to restrictions and authorisation and also have an impact on other chemical legislation. This constant change to substance status means that if companies do not follow the regulatory process very closely, they could find themselves out of compliance, facing removal of their product from the market, or a ban on the use of their substance.
We have seen that REACH triggers the need to keep up with changes which are regularly introduced to the regulation, such as listing as an SVHC, Restrictions, CLP re-classifications, etc. Clearly, effective tracking and management of chemicals in the supply chain is essential to comply with REACH and to minimise the risk of supply chain disruptions.
Having worked extensively with both large companies and SMEs, our experience is that successful REACH management in a business depends on three main factors:
• Clear management support
• Incorporating chemicals management and chemical compliance into the day-to-day activities of staff across
different areas of the business, including procurement, product development, operations and regulatory affairs
• Having effective and robust systems in place to monitor change and trigger related actions for compliance.
In companies where REACH is managed comprehensively, we have seen that compliance responsibilities are accepted by individual departments and incorporated into department procedures, job descriptions and training rather than being driven exclusively by EHS or a limited number of other individuals. In particular procurement has an important role to play.
As new SVHCs, restrictions and harmonised classifications are constantly identified, having as much advanced warning as possible is essential. To monitor the regulatory updates by hand takes a lot of time and resources. Many companies therefore opt to use a chemicals management tool to support this challenging task.
One of the tools used by a variety of industry sectors is chemtrac, a regulatory reference tool aimed at helping companies maintain compliance with REACH and other legislation. Users of the system are managing to save time and reduce their risk of non-compliances and supply chain disruptions (www.chemtrac.co.uk/ourcustomers.php).