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. Reach Akademi 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. Reach Akademi 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 Reach Akademi 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 Reach Akademi 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
Member/Individual Dossier
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. Reach Akademi 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,Reach Akademi has a dedicated team of highly qualified and
experienced professionals who have the capability to develop full Technical Dossier
and Chemical Safety Assessment reports.
Reach Akademi 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, Reach Akademi 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
Reach Akademi 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
Reach Akademi 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.
Reach Akademi 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
Reach Akademi 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, Reach Akademi performs such substance assessments covering a wide range of country regulations. Reach Akademi 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 Reach Akademi!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. Reach Akademi Cosmetic Ingredient profiling covers regulations from USA, Europe, Germany, India, Switzerland, Brazil, China, South Korea, and many more.
Get in touch with Reach Akademi!
