Service Providers
The non-European formulator may incorporate this proprietary material into a mixture, which is exported to their downstream user based in Europe. If the manufacturer does not disclose the chemical composition of the material to the formulator’s OR, the OR is powerless to register the relevant substance(s) and assume regulatory liability If the manufacturer does not disclose the chemical composition of their material to the formulator’s OR, the OR is powerless to register the relevant substance(s) and assume regulatory liability. Regulatory liability would therefore lie on the party responsible for introducing a non-REACH compliant substance to Europe, the recipient of the material, that is, the downstream user. Ideally an arrangement should be in place before European exports commence, which ensures that either the manufacturer (via an OR) or the formulator’s OR completes the necessary registration(s) and risk assessments.
It is essential that the downstream user understands the chain of regulatory responsibility and engages consistently with parties further up the supply chain, to ensure REACH compliance is achieved and maintained. Downstream users under REACH experience many benefits compared to a registrant. However, this is not a reason for complacency. Although operating under a reduced regulatory burden, they must identify their obligations and be prepared to engage with often complex challenges. The role of the downstream user is not a silver bullet for REACH obligations. Ongoing regulatory stewardship is essential before and after a supplier registers their substances. This article has been adapted from a feature in the Global Business Briefing contributed by Dominic Byrne, regulatory affairs manager, Blue Frog Scientific. The views expressed in contributed articles are those of the expert authors and are not necessarily shared by Chemical Watch.
SERVICE PROVIDERS
Outlook generally positive despite global uncertainties
Looking forwards, the only certainty for service providers is the prevailing uncertainty about the business environment and the subsequent level of demand for their services. Big question marks hover over the outcome of Brexit negotiations between the EU and the UK, and the regulatory landscape in the US under newly-elected President Donald Trump. Nevertheless, CEO and head of pest innovations at research company ICB Pharma, Pawel Swietoslawski, believes service providers will continue to be busy with REACH after 2018. “Many companies are still not in full compliance, even in the area of REACH’s main requirement – registration – and they will not succeed until the last registration deadline. Both consultancy and laboratory services will be in high demand for many years forward for substances already on the market and for new ones,” he says. In this latest Chemical Watch survey, laboratory services were most in demand by participants in 2016, accounting for nearly 30% of their total spend [Figure 13]. This was
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followed by equipment with almost 19%, and consultancy services third at 16.5%. Figure 13 SERVICES RETAINED BY PARTICIPANTS
Equipment 18.7%
Training 7.3% Information 6.4% IT & software 7.5%
Other services 3.3%
Consultancy 16.6% Representation & management 4.8% Legal 5.7%
Laboratory 29.8%
Chemical Watch | Global Service Providers Guide 2017