• Notification of new and existing chemicals
• Agrochemicals
• Biocides
• Classification and labelling

EU Chemicals Notification

A wealth of national and European legislation exists for the notification of chemicals throughout the European Economic Area (EEA).

This legislation requires manufacturers and importers wishing to sell chemicals in the EEA to notify their active ingredient or product according to specific legislation including: Biocidal Products Directive (98/8/EC); Pesticides Directive (91/414/EC); new and existing chemicals legislation and the Preparations Directive (2001/60). In addition to statutory legislation, voluntary initiatives such as the current high production volume chemical initiatives (ICCA) need to be considered.

Wainwright Associates can help chemical manufacturers negotiate these complex regulatory requirements and quickly bring new chemicals to the European Union market, whilst ensuring that activities remain compliant with current legislative requirements.

New & Existing Chemicals

Wainwright Associates have the necessary skills and experience to assist companies with the notification of new, existing and high production volume chemical substances and preparations throughout the European Union.

Our input can include:

• Review of existing test data to ensure compliance with the relevant test guidelines and GLP

• Identification of data gaps

• Guidance on individual countries’ regulations and requirements, both in terms of testing and notification submissions

• Database searches

• Preparation of notification dossiers, in compliance with relevant regulatory requirements, for submission to the authorities

• Preparation of risk assessments using EUSES as appropriate

• Compilation of safety data sheets (required for dangerous substances)

• Acting as a sole representative

•Follow up of notifications to ensure smooth approval by the authorities

• Advice on suitable test programmes to ensure timely submission of reports and summaries to the authority

• EU existing substance submissions using HEDSET, or other suitable software

Agrochemicals

With the exception of pesticides that act by purely physical means and biological control agents which are not micro-organisms, all pesticides used in agriculture must be notified to the competent authority of the relevant member state, such as the Pesticide Safety Directorate in the UK.

Wainwright Associates are able to provide a comprehensive consultancy service for approval of agrochemicals. We can:

• Advise clients whether their products require notification under Directive 91/414

• Review current data for completeness

• Negotiate additional testing requirements with the authorities, arrange and monitor studies

• Prepare and submit the dossier to the relevant authority

• Liaise with regulatory agencies during the approval process

Biocides

Notification of a biocidal substance will enable its inclusion in a positive list of permitted active substances (Annex 1). Data must be generated in accordance with the requirements of Annex II and III of the Biocidal Products Directive and notifications made using the IUCLID or other appropriate software.

Wainwright Associates offer the following services for notification of biocides:

• Review of existing test data for scientific adequacy

• Identification of data gaps

• Advice on notification and full dossier requirements

• Preparation of notification dossiers using IUCLID (or other approved software)

Classification & Labelling

European and national law requires that suppliers of chemical substances and preparations provide information on the risks associated with the handling and use of these substances.

Wainwright Associates can undertake:

• Evaluation of risk and safety according to the provisions of relevant classification and labelling directives

• Safety data sheets

• Literature searches