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APC has an extensive team of experts from consultancy, CRO, industry and government backgrounds. This, coupled with a network of consultants covering over 40 countries, means we have excellent relationships with many of the regulators throughout Europe and are well placed to provide up-to-date advice on new guidance initiatives.

Regulation (EC) No.1107/2009 (which replaced Directive 91/414/EEC) entered into force on the 14th June 2011. Its aim is to harmonise the registration of plant protection products across the EU, as well as introduce some new requirements such as hazard based criteria, assessment of cumulative and synergistic e�ects, comparative assessment and endocrine disruption. APC's regulatory team monitors all developments in this area and is able to advise on the implications of the revised data requirements on your dossier.

Experienced

APC's experts have many years of practical experience in conducting and managing a wide range of studies. Their experience ranges from laboratory to �eld based studies for a wide variety of products and uses.

Risk assessment forms a critical part of the dossier and our experienced scientists have the knowledge to interpret exposure and e�ects assessments and apply re�nement where possible. Re�nement can also take the form of higher tier testing for which APC can o�er advice on both planning and placement of studies in appropriate CROs.

Knowledgeable

Under the previous legislation, Directive 91/414/EEC, approval of the active substance (termed Annex Iinclusion) was given for a period of 10 years with a second review to be completed before the end of the 10 year period. This was to ensure that risk assessments were kept up-to-date and that plant protection products continued to be used safely.

Similar to the �rst review programme for existing active substances under 91/414/EEC, the renewal programme for approved active substances under Regulation (EC) No.1107/2009 will be issued via speci�c Regulations.

Regulation (EC) No.1107/2009 also contains a provision for a Regulation to be adopted by 14 December 2014 establishing a programme for the gradual review of safeners and synergists already on the market.

APC has a dedicated REACH team with an extensive background in the chemical industry coupled with the expertise to support clients with the management of substances within REACH legislation. APC can provide advice and technical or regulatory support for all levels of registration under REACH, whether you are a manufacturer, importer or a downstream user of the substance, using the substance as sold, or in a preparation or article.

Negotiation and representation

APC has many years of experience in negotiations with regulatory agencies and will represent the client in discussions with the ECHA (European Chemicals Agency) and speci�c Member States when required.

APC's experience of negotiation within task forces will be applied when supporting your interests in Substance Information Exchange Forums (SIEFs), whether for data and cost sharing or compensation issues.

APC’s technical experts are skilled in literature searches, analysis of data sets, identifying data gaps and gap �lling using methods such as read-across or (Q)SAR modelling. Following identi�cation of any data gaps APC’s internationally recognised regulatory scientists will negotiate, place and monitor any necessary studies on the client’s behalf.

APC will conduct safety assessments and prepare the Chemical Safety Report (CSR) for substances greater than 10 tonnes.

For substances above 1000 tonnes and SVHCs (Substances of Very High Concern), APC can conduct the ECHA required chemical testing and prepare environmental/human health exposure assessments with appropriate risk management measures.

APC has wide experience of using IUCLID and will manage the entry of data (including the pre-registration of substances) into IUCLID 5.