We are greatly experienced in the preparation of submissions for new and existing active substances under the Directive 91/414/EEC work program. We have prepared and submitted CADDY and paper copies of over 20 complete active substance dossiers. Many of these compounds have been seen through to Annex I listing in partnership with our clients, as we have addressed complex scientific issues arising during EU peer review.
After Annex I listing, there are many more regulatory hurdles to overcome and JSC are closely involved in the challenging negotiation of National re-registration, including complex data protection issues. We help clients achieve market entry in a timely manner by integrating high-quality scientific expertise, with an in depth knowledge of the regulatory process.

Further information is available in the secure download area

The Biocidal Products Directive (98/8/EC) covers 23 different product types, including among others disinfectants, preservatives, and pest control agents. Under a series of Review Regulations all active ingredients have been identified or notified and a prioritised programme of evaluation established. The BPD is having a major impact on the range of biocides available on the EU market.
JSC has the scientific, regulatory and biocide industry-specific knowledge to support the complete registration programme. We are able to advise on regulatory strategy and scope issues, to assess toxicology and environmental datasets for completeness, prepare data waivers, manage any testing requirements through independent testing facilities, undertake risk assessments, participate in taskforces, and produce dossiers for submission to regulatory authorities. We can work on a project-by-project basis, or provide full management of a submission through to final approval.

Further information is available in the secure download area

Registration requirements for biopesticides are under gradual development and require specialised skills to ensure successful Annex I listing and product registrations. Each case has to explore the highly specific features of the substance or organism, define key data requirements and by focusing on the use pattern, and construct sophisticated justifications to maximise the value of the often limited available data.
JSC has strong in-house capability in this area and a proven track record via the achievement of Annex I listing for two micro-organisms. We are actively working on submissions for List 4 substances and micro-organisms.

On 1st June 2007, REACH (Registration, Evaluation, Authorisation and restriction of CHemicals) entered into force. REACH applies to chemical substances manufactured, imported, placed on the market or used within the European Community, either on their own, in a preparation or in an article.
Substances manufactured or imported in quantities of 1 tonne/annum (tpa) or more may need to be registered with European CHemicals Agency (ECHA). This requires submission of a technical dossier. For substances of 10 tpa or more a Chemical Safety Report (CSR) is required. Substances of Very High Concern (SVHC) may be subject to further evaluation and may require authorisation before use is permitted.
Deadlines for Registration of “phase-in” substances: To manage the vast number of existing (“phase in”) substances, a staggered system for registration has been introduced with deadlines dependent on volume and hazard as follows: 1 December 2010 - 1000 tpa and above; 100 tpa and above (R50/53); 1 tpa and above (CMR Category 1 or 2). 1 June 2013 - 100 tpa and above. 1 June 2018 – 1 tpa and above.
It is very important to note that “phase-in” substances must be pre-registered with ECHA between 1 June and 1 December 2008 to qualify for the staggered deadlines. If not, substances have to be registered straight away.
New (“non phase-in”) substances require registration from 1 June 2008.
How can JSC help?
JSC have an in-depth knowledge of REACH and staff fully trained in the use of IUCLID 5. We can support you through the REACH process, steering you through the complexities of the Regulation, helping you understand your obligations and assisting you with the preparation of regulatory submissions and beyond.
Our services include the following: Compilation of substance inventories, identification of SVHC and management strategies; Preparation of pre-registration data packages and pre-registration submissions; Preparation of regulatory dossiers including: identification of registration requirements and deadlines; review of existing data packages and gap analysis, preparation of data waivers, Robust Summaries, risk assessment and risk mitigation; recommendation of appropriate testing facilities (we can act as study monitor where additional testing is required). We can also help with the preparation of notifications for Classification and Labelling, Third party representative and representation of clients at SIEF and Consortia and liaison with and representation of clients at the Regulatory Agency.

JSC provides training courses and seminars both at International conferences and in-house.
Every year, JSC presents a one-day seminar on dossier preparation and the OECD format at the IBC conference, and more recently we have developed and presented interactive seminars on regulations and risk assessments under 91/414 and 98/8. We have also provided training on 91/414/EEC to acceding Member States and bespoke seminars for companies requesting training for their staff.
If you have any enquiries about training, please contact us at enquiries@jsci.co.uk

JSC are experienced in supporting clients with applications for MRLs and Marketing Authorisations for veterinary medicines in accordance with the rules governing medicinal products in the EU. Over 20 residue expert reports have been prepared involving a range of therapeutic products. We can advise on the suitability of existing studies and if additional data are needed.

Biopesticides require specialised skills to ensure successful Annex I listing and product registration. We explore the highly specific features of the substance or organism, define the key data requirements, and construct sophisticated justifications to maximise the value of often limited data.
JSC has strong in-house capability and a proven track record in this area, having achieved Annex I listing for two micro-organisms. We are currently working on submissions for several micro-organisms and other List 4 substances.

Further information is available in the secure download area

JSC International have considerable experience with regulatory procedures and have been able to advise clients in a number of areas not related to plant protection or biocides. We have supported customers with technologies involving novel food processes which are subject to assessment by the UK Food Standards Agency as UK competent authority.

Biochemicals are naturally occurring substances usually derived from plants or plant products or synthetic compounds based on naturally occurring substances. Many of these substances are of low risk and can be supported by a reduced data package. Such substances have been included in the 4th stage of the Review Programme under 91/414/EEC. JSC International have considerable experience in navigating through the data requirements for these compounds.

The Globally Harmonised System of Classification and Labelling is a new system for classifying and communicating chemical hazards, and is due for introduction in the EU in 2008. Countries, international organizations, chemical producers and end users will all benefit as GHS will enhance human and environmental protection, facilitate international trade in chemicals, reduce need for testing and evaluation, and assist in the sound management of chemicals.
JSC can advise on how GHS will affect you and what action will need to be taken. We can classify your products under GHS, redraft safety data sheets and labels to ensure compliance during the transitionary period, and develop GHS compliant labels.

JSC has considerable experience in the preparation of submissions for new and existing active substances under 91/414/EEC. We have prepared and submitted CADDY and paper copies for over 20 complete active substance dossiers. Many of these compounds have been seen through to Annex I listing, and in partnership with our clients we have addressed complex scientific issues arising during the EU peer review process.
There are many more regulatory challenges to overcome following Annex I listing, and JSC are closely involved in all aspects of national re-registrations, including complex data protection issues. We help clients achieve market entry by integrating high-quality scientific expertise with an in-depth knowledge of the regulatory process.

Further information is available in the secure download area

Products derived from plants, or synthetic compounds based on naturally occurring substances, are often of low risk and can be supported by reduced data packages. Such substances have been included in the 4th stage of the Review Programme under 91/414/EEC. JSC has considerable experience of navigating through the data requirements for these compounds.

JSC are able to advise on safety issues surrounding consumer products, and to assist in classifying and labelling issues to ensure regulatory compliance across the EU. We are able to provide expert advice on testing requirements and claim support for specialist consumer products such as biocides (e.g. disinfectants and antimicrobial products) as well as for household pesticides.