Regulatory Support
General technical support
Elements Advisory offers support with:
Data gap analysis (including development of waivers, read-across statements, etc.)
Study monitoring and adaptation of testing plans where required
Dossier preparation using the official tools and templates (IUCLID, SPC, PAR, etc.)
Modelling and development of exposure scenarios
Toxicological and ecotoxicological hazard assessment
Preliminary or full risk assessment
Check of your classification and labelling (CLP (EU) No 1272/2008)
Development and assessment of the efficacy data package
Assessment of the endocrine disruptor (ED) potential of your active substance and co-formulants
Comparative assessment
Literature review according to the EFSA systematic review methodology
Poison Centre Notifications (UFI)
Label Review
Follow-up of your dossier
Elements Advisory’s team has long-running relationships with authorities, the European Commission and ECHA. The follow-up of your dossier consists of:
Processing and review of comments of the authorities at EU and national level
Refinement of the risk assessment
Setting-up post-submission meetings with the authorities if necessary
Development of expert statements
active substances
Elements Advisory can help with different applications for active substances, for example:
Renewal of your active substance dossier
Article 95 applications
Technical equivalence (TE) assessment
biocidal products
To maintain your products or to include new products on the market, Elements Advisory can assist you in:
Your compliance to the national legislation under the transitional provisions if your active substance/PT combination is included in the Review Programme (EU) No 1062/2014 and not evaluated yet.
Your compliance to the BPR regulation if the evaluation of your active substance is completed or due to be completed. We can assist you with:
Single product applications
Biocidal product families
Simplified authorisations
