Management and Representation
When companies focus on exporting their business, or expanding their exporting business, to regions where meeting compliance requirements are key bottlenecks, it becomes important to navigate through the compliance field in efficient ways. GPC’s Management and Representation services’ core purpose is to help companies navigate through different regulatory requirements present in different countries and regions.
Attaining our services would also enable exporters to minimize their risk and dependency on local buyers for future business purposes. GPC’s Management and Representation services cover countriesand regions across the globe, and help companies comply with regulatory requirements in the sectors of: chemicals, cosmetics, food-additives, agrochemicals, and pharmaceutical ingredients.
Our Management and Representation services include:
• Only Representative (OR)
• Nominated Representative (NR)
• Authorized Representative (AR)
• Third-Party Representative (TPR)
• Responsible Person
• Compliance Representative (consultant)
Preliminary Compliance Submissions
By assigning GPC as a regulatory and compliance representative, companies can continue their business as usual, locally and invarious export destinations, regardless of new regulations being introduced. Companies can process preliminary compliance requirements that provides businesses advantages of the transition phase, which may be outlined within respective regulations. During the 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.
Our 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 a compliance status is communicated to the supply-chain, on request. This also includes confirmation to competent authorities regarding companies’ compliance. GPC facilitates reporting of your company’s exports to competent authorities when required.
Our Annual Compliance Management includes:
• Tonnage coverage certificate to buyers
• Representative (compliance) certificate to supply-chain
• Communication and Supply Chain
• Communication within the substance registration process
• Regulatory update (generic & substance-specific)
• Export declaration and Reporting
Substance Specific Regulatory Assessment and Compliance Support
Companies can seek assessment and implication analysis from GPC regarding different regulatory aspects. 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.
Our Substance Specific Assessments and Compliance supportincludes:
• 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
• Poison Center Notification
Classification Labelling (C&L) and Safety Data Sheet (SDS)
Companies are required to provide classifications, labeling, and Safety Data Sheets in accordance with UN Globally Harmonized Systems of Classification and Labelling, or relevant adaptations as may be applicable in different countries, e.g. CLP in case of EU.
It is essential to provide this information in accordance with UN GHS and local language to the downstream user. Therefore, GPC offers a variety of such services in different countries, and for different needs.
GPC provides C&L and SDS services for over 30 countries:
• CLP Notification of substances
• CLP Notification of the Mixtures
• Poison Center Notification
• Safety Data Sheet for Substance (local language)
• Safety Data Sheet for Mixtures (local language)
• Extended Safety Data Sheet (local language)
Registration Process Management
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 substances being placed in the 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 or region, substance registration is a key requirement.
GPC can manage entire Registration Processes, 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
When companies join the Joint Submission with the purpose of registering a substance, it requires submitting a member dossier, also known as an individual dossier. GPC facilitates indeveloping and submitting the member dossier.
The following services are included in our Member dossier preparation:
• Member dossier preparation
• Inquiry dossier preparation (where required)
• Spectral analysis to establish substance identity (monoconstitute)
• Spectral analysis to establish substance identity (multiconstitute, 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 professionals who have the capability to develop full Technical Dossier and Chemical Safety Assessment reports.
GPC’s 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
• Managing and Monitoring of New Studies (where required)
• Final checks – dossier completeness and compliance
• Submission via IT system
Chemical Safety Assessment
Companies who may want to prepare their own Chemical Safety Report (CSR), or update an existing CSR with new data or uses, requires a wide range of expertise and competencies. For those situations, GPC has a dedicated team of highly qualified and experienced professionals who have the capability to developfull Technical Dossiers and Chemical Safety Assessment reports.
The 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, where the substances are identified for evaluation by the regulators, requires them 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 are crucial. GPC supports companies to follow-up the evaluation process on their behalf, whereas GPC’s toxicologists, eco-toxicologists, environmental fate and chemistry experts, along with chemical safety assessors and legal experts can defend the evaluation process for the company on its behalf.
GPC’s 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 who are interested in the regulatory treatment of a substance in various countries according to respective food safety regulations, GPC performs such substance assessments covering a wide range of country regulations. GPC’s Food Safety profiling of a substance covers regulations from USA, Europe,Germany, India, Switzerland, Brazil, China, South Korea, and many more.Get in touch with GPC!
Global Substance Specific Compliance Assessment For Cosmetic Ingredients
Companies who are interested in the regulatory treatment of asubstance in various countries according to respective cosmetic regulations, GPC also performs such substance assessments covering a wide range of country regulations regarding cosmetics. GPC’s Cosmetic Ingredient profiling covers regulations from USA, Europe, Germany, India, Switzerland, Brazil, China, South Korea, and many more.Get in touch with GPC!