Services

MANAGEMENT & REPRESENTATION

While companies focus on the export business, and even expand exports, in regions where meeting compliance requirements are key bottlenecks, by assigning GPC responsibility of compliance management on your behalf. This also would enable exporters to minimize business risks and dependency on the local buyer for future business. GPC’s Management and Representation services cover countries across the globe and help in compliance with regulatory requirements in sectors - chemical, cosmetic, food-additive, agrochemicals, and pharma ingredients. Management & Representation services include:

• Only Representative (OR)
• Nominated Representative (NR)
• Authorized Representative (AR)
• Third-Party Representative (TPR)
• Responsible Person
• Compliance Representative (consultant)

PRELIMINARY COMPLIANCE SUBMISSIONS

Companies could continue business as usual, locally and in various export destinations, regardless of new regulations being introduced, by assigning GPC as a regulatory & compliance representative. Wherein it can process preliminary compliance requirements, that provides businesses advantages of the transition phase, as may be outlined within respective regulation. During transition phase businesses can continue and expand their activities in a country. This also facilitates companies to be actively engaged at an early stage with key compliance processes such as substance identification, registration, classification, cost, etc. Preliminary compliance processes include:

• Notification to Inventory
• (Late) Preregistration
• (Late) Notification
• Stage one Registration
• Pre-Substance Information Exchange Forum (Pre-SIEF)
• New substance notification
• Phase I registration

Annual Compliance Management Subscription

Companies that have initiated a preliminary compliance process, would benefit from GPC’s independent compliance verification and certification. Such compliance status is communicated to the supply-chain, on request. This also includes confirmation to competent authorities on companies’ compliance. GPC facilitates reporting of your exports to competent authorities where required. Annual Compliance Management includes:

SUBSTANCE SPECIFIC REGULATORY ASSESSMENT & COMPLIANCE SUPPORT

Companies can seek assessments and implications analysis, from GPC, on different aspects of regulation. Such Assessments and analysis help companies to stay on the right side of compliance. Certain assessments and analysis may necessitate further process notifications and submissions to the authorities. Substance Specific Assessments & Compliance support includes:

• Regulatory Applicability Assessment
• Substance Exemption Assessment
• New / Existing Substance Assessment
• Restricted Substance Assessment
• Prohibited Substance Assessment
• SVHC Substance Assessment
• Priority / PEC Substance Assessment
• Substance subject to intensive control assessment
• Polymer (or NLP) Substance Assessment
• OEL Compliance Assessment
• SVHC Notification
• Poision Center Notification

CLASSIFICATION LABELLING (C&L) AND SAFETY DATA SHEET (SDS)

Companies are required to register substances at the end of the transition period (Registration Deadline), which may in most cases be dependent on the quantity of substance being placed in that local market. The principle of “no-data no-market” applies in most regulations. To maintain compliance and to continue to do business in a country/region substance registration is a key requirement. GPC can manage entire Registration Process and this includes:

• Consortia communication (SIEF, CICO, etc.)
• New and existing (Phase-in) substance registration
• Inquiry Dossier Preparation
• Substance Sameness & Identification
• Member dossier preparation
• Technical dossier preparation (robust study summary)
• Opt-out (from joint submission) justification and dossier preparation
• Chemical Safety Assessment
• Submission of Registration to the IT system

REGISTRATION PROCESS MANAGEMENT

Companies when joining the Joint submission, for registering a substance, requires to submit a member dossier, also known as individual dossier. GPC facilitates in developing and submitting the member dossier. Following services are included for Member dossier Preparation:

• Member dossier preparation
• Inquiry dossier preparation (where required)
• Spectral analysis to establish substance identity (mono constitute)
• Spectral analysis to establish substance identity (multi constitute, UVCB)
• Substance Sameness & Identification

DEVELOP FULL TECHNICAL DOSSIER

Companies may take a lead position to register a substance or may want to submit an opt-out dossier wherein a wide range of expertise and competencies are required. In such a situation, GPC has a dedicated team of highly qualified and experienced professional that have capabilities to develop full Technical Dossier and Chemical Safety Assessment report. GPC model for technical dossier preparation involves:

• Detailed research on relevant existing information,
• Acquiring existing (qualified) data
• Seeking permission to use scientific literature.
• Prepare robust study summary,
• Identify areas where wavers may be applicable,
• Identification of data gaps,
• Identification of Read Across, and
• Managing & Monitoring of New Studies (where required).
• Final checks – dossier completeness and compliance
• Submitting via IT system

CHEMICAL SAFETY ASSESSMENT

Companies may want to prepare their own Chemical Safety Report (CSR), or may want to update an existing CSR with new data, or uses, such activity requires a wide range of expertise and competencies. In such a situation has a dedicated team of highly qualified and experienced professional that have capabilities to develop full Technical Dossier and Chemical Safety Assessment report. Chemical Safety Assessments at GPC involves:

• Persistence, Bio-accumulative, and Toxic (PBT) Assessment
• Carcinogenic, Mutagenic, Reprotoxic (CMR) Assessment
• Endocrine Disruption (ED) Assessment
• Environmental Risk Assessment
• Chemical Safety Assessment (not Classified substance)
• Chemical Safety Assessment (Classified substance)

EVALUATION PROCESS MANAGEMENT

Companies that have registered substances and the substances are identified for evaluation by the regulators, require to closely follow the evaluation process with full techno-legal justifications and arguments drawn from high-level scientific information and its interpretation. A timely follow up of the process and a thorough understanding of the evaluation stages is crucial. GPC supports companies to follow-up on their behalf the evaluation process, wherein its toxicologists, eco-toxicologists, environmental fate & chemistry experts along with chemical safety assessors and legal experts can defend the evaluation process on the company’s behalf. GPC evaluation process management covers the following:

• Evaluation Process Consultation
• Interaction with Regulators / competent bodies
• Interaction with other Joint Submission members
• Action Plan based upon Draft Decision review – Response, Justifications, proposals
• Action Plan based upon Final Decision review – study, CRO monitoring, Cost-sharing, Dossier update
• CRO Management & Monitoring
• Study interpretation & Endpoint summary preparation
• Update of Chemical Safety Assessment
• Follow up with regulators on the closure of Evaluation process

GLOBAL SUBSTANCE SPECIFIC COMPLIANCE ASSESSMENT FOR USE IN THE FOOD INDUSTRY

Companies may want to know the regulatory treatment of a substance, in various countries according to respective cosmetic regulations. GPC performs such a substance assessment covering a wide range of country regulations. GPC’s Cosmetic Ingredient profiling covers regulations from, USA, Europe, Germany, India, Switzerland, Brazil, China, South Korea, etc.

GLOBAL SUBSTANCE SPECIFIC COMPLIANCE ASSESSMENT FOR COSMETIC INGREDIENTS

Companies may want to know the regulatory treatment of a substance, in various countries according to respective cosmetic regulations. GPC performs such a substance assessment covering a wide range of country regulations. GPC’s Cosmetic Ingredient profiling covers regulations from, USA, Europe, Germany, India, Switzerland, Brazil, China, South Korea, etc.