Consultancy


Consultancy

Laronkarn specialises in providing regulatory support to companies who wish to place Plant Protection Products (PPP), Biocides or REACh onto the market. It deals with pesticides (insecticides, fungicides, molluscicides, repellents, rodenticides and plant growth regulators) as well as the 22 Biocide and non-agricultural pesticide groups that fall under the Biocidal Products Regulation (528/2012)

When Laronkarn is approached by a client, a comprehensive strategy is proposed on the best way to achieve the client’s business objectives, whether it is a Plant Protection Product, a Biocide or falls under REACh.

Plant Protection Products (PPP) (EU Directive 1107/2009) – Biocides (EU Directive 98/8/EC and from 1st Sept 2013 528/2012)

Once the client has agreed to a strategy Laronkarn then researches what data is currently available and identifies potential data gaps. Laronkarn then approaches the necessary Regulatory/Competent Authority  (whether it is for a National or Zonal application) to ensure what is proposed is acceptable to them and to ensure the successful submission of the application. After this the necessary data is commissioned and duly monitored in-house as Laronkarn has built up a global network purposefully to assist their clients.

When the data is received then OECD/IUCLID summaries are compiled and duly entered into the relevant sections of the dossier (dossiers for PPP are compiled using Draft Registration Reports (dRR) and IUCLID is used for compiling Biocidal dossiers) and duly submitted to the relevant Authority.

REACH (EU Regulation 1907/2006)

REACh is an EU regulation that monitors chemicals in order to improve the protection of human and environmental health. It does this by Registration, Evaluation, Authorisation and restriction ofChemicals that entered into force on 1st June 2007. It does not apply to countries outside the EU but all countries exporting into the EU have to abide under this regulation, although China has adopted their own version of REACh.

There is a deadline of 1st June 2018 for submission of IUCLID dossiers for substances that are produced>1000tpa. These substances will require additional information over the preceding tonnages.

All data that is generated is monitored carefully by expert staff according to Good Laboratory Practice (GLP) or Good Experimental Practice (GEP) to ensure that the reports will be acceptable to the authority(ies).