Companies are facing ever increasing regulatory hurdles which require specialist input to ensure both compliance with the law and development of regulatory competitive advantage.
Over the past few years we have seen a number of major revisions to existing legislation within the EU, some key areas are summarised below:
Biocide legislation
The BPR (Council Regulation (EU) No 528/2012) has now replaced the BPD and will have a significant impact on industry. The BPR requires that all suppliers of active substances are included on a list of approved suppliers published by ECHA by 01 September 2015; this means that companies that were previously not involved in supporting their active substances must now become actively involved in the regulatory process or exit the market. Another big change is that treated articles are now in scope of the biocides legislation, potentially this brings within scope a huge number of products e.g. those containing preservatives. The requirement to obtain product authorisation continues for biocidal products, practically this means that many products that were previously only lightly regulated under the old national rules in many countries will now require extensive product dossiers to be submitted in order for products to remain on the market. Despite the fact that the BPR has only recently been introduced it is being redrafted. JSC is monitoring any changes closely.
Agrochemical Pesticides
Council Regulation (EU) No 1107/2009 has introduced a number of significant changes to how agrochemical pesticides are regulated within the EU with a move away from risk based towards hazard based assessment. Like the BPR the agrochemical legislation includes exclusion/approval and substitution criteria. Uses of those substances identified as Candidates for Substitution will be subject to Comparative Assessment from 01 January 2015. The Regulation includes a requirement to consider endocrine disruptor effects. Fully agreed criteria for implementation of this requirement are now not expected to be in place before the end of 2015. In the meantime transitional measures apply.
REACH / CLP
The third and final deadline for phase-in substances requiring registration under REACH (Regulation (EC) 1907/2006) is 01 June 2018. This deadline will involve the registration of large numbers of the smallest tonnage chemicals (1-100 tonnes/year), which creates its own challenges prompting ECHA to encourage companies to start work early.
In addition to the last tonnage phase, ongoing regulatory support will be required for existing dossiers submitted at the 2010 and 2013 registration deadlines, changes in tonnage bands, feedback on testing proposals as well as issues such as SVHC’s, endocrine disruptors and authorisation applications.
CLP (European Regulation (EC) 1272/2008) the EU’s version of GHS, will have a significant impact on preparations (mixtures) as the June 2015 deadline requires suppliers to classify, label and package according to CLP. Products already in the supply chain and classified according to the Dangerous Preparations Directive have a two year sell though to remove existing stock.
Due to the ever increasing quantity and complexity of EU legislation companies are encouraged to seek regulatory support at an early stage to ensure regulatory compliance can be maintained and products can continue to be sold. JSC International Limited can support you in meeting these regulatory challenges and can supply the specialist technical expertise needed.
