REACH simplification should focus on making authorisation timely and cost-effective
While safety should always come first when assessing the effects of chemical substances, an unfair financial and administrative burden is being placed on companies, writes Nicola Caputo.
One of the main objectives of the EU's REACH chemical regulation system is to provide a high level of protection for people and the environment.
A key part of this system is the authorisation process, which incentivises companies using the most problematic chemicals to switch to safer alternatives.
The implementation of the authorisation requirement so far has shown that in certain cases, it can constitute a significant administrative burden for the companies concerned. In fact, the level of administrative support needed for REACH authorisation, and the time taken to form consortia to share best practice, can be significant.
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For SMEs in particular, the cost of compliance is focused on seeking to comply with their customers' REACH processes and initiatives. The volume of documents, forms and surveys requires SMEs to build significant compliance costs into business plans - all of which are affected by a further complex REACH authorisation process.
Within the regulatory fitness and performance programme (REFIT), the European Commission committed to examining ways of reducing the administrative burden of REACH on companies.
In my opinion, the authorisation procedure should be simplified in specific cases where the use of substances of very high concern presents a low risk.
When these substances are used in very low volumes, the cost of a full-scale authorisation application can be disproportionate for companies. Therefore, in such cases, perhaps authorities could request limited documentation.
Regarding the necessity to reduce documentation, it is also important to note that many component manufacturers that are subject to qualification or certification do not have design control. As such, they are unable to assess alternative chemicals, as these are fixed in the production process.
For applications for low volume authorisation, and where there are significant certification procedures surrounding these substances, the requirement for socio-economic analysis and analysis of alternatives should be reduced and the focus shifted onto whether the company in question has sufficient protection control in place for its employees when using the substance.
A simplified authorisation procedure should also include a mechanism whereby a company can be confident that it can be granted authorisation in a timely and cost effective manner.
The current process, which has no clear, defined and accepted duration, incurs significant costs for business, is disproportionate for substances used in low volumes and can take away crucial funding from business development, export and R&D activity, all of which are vital for competitiveness.
Given all of these elements, it is essential to simplify the existing EU regulatory system for chemical substances. This will give greater understanding, more consistency and predictability for those employers, SMEs and companies that operate in this very complex regulatory environment.
However, any kind of simplification which could lead to increased chemical risks should be brushed aside.
MEPs have the chance to support innovation and evidence-based authorisation procedures when they meet next week in Strasbourg, says Pedro Narro Sanchez.
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