Representation Services (OR, RP, AR)
Representation Services: Representation Services offered by SSS includes Only Representative, Authorized Representative, Third Party Representative, and Responsible Person. SSS is one of the largest Representation Service Providers and it provides cost-effective Representation Services to over 900 companies from over 27 countries and represents over 8000 substances.
If you are looking for a cost-effective Representation service for a particular regulation or wish to change representation service to a new Representative, please do not hesitate to contact us for further advice.
SSS is one of the largest OR service providers in the EU and it represents over 800 companies from 27 different countries. Our overall representation includes 8000 substances, wherein SSS manages compliant status of the substances, authors and documents REACH compliant SDSs, manages SIEF & supply-chain communications, issues compliance certificates to Buyers, manages various regulatory submission and also follows up on various communications with competent authorities / bodies.
SSS provides OR services through its associate in Korea to about 100 companies within the scope of Korea Reach or K-REACH, wherein SSS manages the compliant status of substances, authors and documents K-REACH compliant SDS, manages SIEF & supply-chain communications, issues compliance certificates to Buyers, manages various regulatory submissions and also follows up on various communications with competent authorities / bodies.
For more details visit : SSSKorea.com
SSS can provide, through its associates, Representation services for following Regulations in following Geographical regions:
|EU-REACH||Only Representative (OR) & Third-Party Representation (TPR)|
|K-REACH||Only Representative (OR)|
|EU-Cosmetics||Responsible Person (RP)|
|US-FDA||Authorized representative (AR)|
|Turkish REACH||Only Representative (OR)|
|China REACH||Registration Agent (Local Chinese Agent)|
|Philippine (PMPIN)||Third Party|
Chemical Registration: SSS has extensive experience of working with chemicals, cosmetics, dyes & pigments, Food chemicals, flavors and fragrances, agro-chemicals, APIs and pharma sectors. We have facilitated registration of these substances in different countries within respective regulations.
SSS’s Expert team of chemists, toxicologists, Eco toxicologists and risk assessment professionals offer a full range of registration services, including interaction with authorities, advising, preparation of relevant dossiers and applications, finalizing submissions and post submission support. We provide qualified service in preparing full technical and member dossiers in IUCLID software. The service also includes deciding on substance identification, cost sharing discussions, letter of access (LoA), collecting all relevant documents on behalf of clients such as Chemical Safety Assessment Report, and letter of Access (LoA), Reimbursements of LOA as and when applicable.
Since 2008, SSS has worked hard to help its client companies successfully meet the respective registration deadlines of 30th Nov. 2010, 31st May 2013 and 31 May, 2018 within REACH Regulation. SSS successfully registered around 1200 substances, including 1000+ substances as the lead registrant by the last REACH registration deadline of 31 May 2018. SSS also facilitated several Full-opt-out dossier submissions, where the client requested so because of high cost indicated by the Lead.
With the completion of the last REACH Registration deadline of 31.05.2018, the companies can use their pre-registration numbers only for processing their Registrations, but this will be only valid for a short term. All potential registrants, either companies who had pre-registered but the pre-registration has lapsed or those who did not pre-register at all, would be required to process their Registrations through the direct enquiry route. SSS helps its clients to prepare enquiry dossier along with substance identification and continues to register substances for its clients through this procedure.
The Act on the Registration and Evaluation of Chemical Substances (ARECS) regulation also known as K-REACH had come into effect in South Korea from 1st January 2015. SSS acts as an OR on behalf of non-Korean manufacturers and helped many non-Korean clients with following services for their businesses:
- Registration (in first deadline of 31st June 2018).
- Pre-registration (to be done before June 2019 – like EU REACH).
- Reporting the uses and quantity of the chemical substances, in accordance with Article 8 of the regulation.
- Submitting the risk assessment report based on the tonnage exported.
GHS Compliant Safety Data Sheets (SDSs)
GHS Compliant SDSs: SSS provides qualified service of authoring Safety Data Sheets (SDSs) in accordance with Global Harmonized System (GHS) and regulations based upon GHS by various countries and regions for the chemical substances and preparations. We provide SDS authoring for over 35 Countries in their local Languages and English. A sixteen-chapter SDS authoring includes substance specific information, classification, labelling and packaging of substance, first aid measures, fire-fighting measures, toxicological and phys-chem properties, relevant exposure scenario of the substance, regulatory information and transport regulation requirement of the substance. Typically, an SDS authoring is completed within seven working days.
SSS provides SDS for all substances and e-SDS for the classified registered substances with the relevant exposure scenarios. So far, SSS has authored SDSs for more than 2800 substances within CLP and 200 e-SDSs with exposure scenario. SSS has ability to provide SDSs in all the 27 EU languages.
- Canada (English / French)
- Switzerland (French / German)
- United States
SSS also provides English authoring and machine translation service of SDS / eSDS for all European Union country languages (German, Italian, French, Spanish, Swedish, Romanian, Hungarian, Czech Republican etc.). In Addition, it also provides SDS/eSDS in Chinese, Korean, Taiwanese, Malaysian, Turkish, Vietnamese, Russian, Serbian, Norwegian etc.
We have done SDS/eSDS translations for more than 550 substances so far and continue to provide the service to our clients
Key information to companies placing hazardous mixtures on the EEA market:
A new label element will appear on product labels from 2020 – a 16-character code called the unique formula identifier (UFI). By 2025, the UFI will be mandatory on the label of all products classified for health or physical hazards.
All Suppliers will have to provide specific product information, including the UFI, to poison centers.
SSS can help all the suppliers and importers/Distributors for Poison center notification . For more details please contact [email protected]
Compliance Certificates: SSS has developed systems and tools to efficiently perform due diligence via document verification and inspections and issue compliance certificates. Compliance certification is frequently required by the buyer so that it can continue to trade with a particular supplier and SSS does various checks and in case there are gaps it first facilitates supplier to fulfill the gaps and then issues the certificate. SSS has reviewed respective regulatory requirements for target country and has issued compliance statements and certificates to over 3000 downstream users of about 1000 clients.
The OR confirmation is provided by SSS for its clients, to various downstream users after verifying all relevant details of the client such as agreements, active status, substances, tonnage, uses etc. SSS issues 8 – 12 OR confirmation certificates each month. Now returning buyers can directly access, via SSS online Supply-Chain Communication Portal, the OR confirmation certificate for given supplier and given substance.
The OR maintains an account of the tonnage of each substance of each client and continuously compares it with the registered tonnage so that the client remains within the registered tonnage band and in case it is approaching the maximum limit, then it is indicated with an option to upgrade the tonnage.
Now returning buyers can directly access, via SSS online Supply-Chain Communication Portal, the Tonnage Coverage Certificate for given supplier and given substance. SSS issues 15 – 18 Tonnage Coverage Certificates each month.
Substance Assessment: Substance Assessment is required for companies to confer with various inclusion lists, watch lists and exclusion lists. Its very important that such assessment is done by an independent third party to ensure an unbiased assessment and to avoid any conflict of interest. The Downstream uses and other consumers of such information also associates greater reliance on independent assessments. SSS regularly performs such assessments and issues relevant certificates to the Client or Downstream users.
Companies exporting articles to European countries need to confirm the presence or absence of Substances of Very High Concern (SVHC) within the REACH compliance obligations.
SSS offers a cost effective and technically sound solution to companies for fulfilling their REACH obligations and certification requirement of their European buyers. SVHC is assessed within various articles – Plastic & polymer articles, Toys, Leather articles, garments, auto components, electronics etc. In addition, SSS also performs SVHC assessment of Formulations and multi-constitute substances.
The Annex XVII of REACH regulation contains the list of restricted substances with certain hazardous properties present as such or in mixtures and articles for their marketing and use in the European market within regulation.
A restriction can apply to any substance on its own, in a mixture or in an article, including those that do not require registration under specific use conditions.
SSS offers assessment of restricted substances in articles and provides recommendations where such substances are present.
SSS performs independent substance assessment and provides a full and qualified technical solutions for the same. Substance assessment in various products such as Textiles, Garments, Leather, Plastics, Electronic Products, Auto-components etc. are performed by SSS.
The service includes checking the ingredient provided by Buyer / Brand owner in various Negative and Positive list and also it is checked in our database of global regulations and norms, and if any concerns are identified, relevant technical solutions are suggested for the product so that it can comply with the Brand owner’s requirements and also with relevant applicable regulations.
Such assessments greatly curtail the possibility of product rejections because of non-compliance with Regulatory and Voluntary Norms.
GLP Study Monitoring and Management
GLP Study Monitoring and Management: SSS coordinates with a network of reputed CROs (OECD-GLP Certified), wherein we manage studies on behalf of external clients, take study contracts and do full study coordination and monitoring on behalf of the sponsor, in a more cost-effective and time-efficient manner. We have facilitated several EU and Asian clients in this manner.
We can facilitate following studies, in addition to substance identification, stability and homogeneity studies, from the OECD/GLP compliant laboratories.
- Acute Toxicity (Oral, Dermal, Inhalation)
- Irritation Studies (Skin and Eye) (In vivo)
- Irritation Studies (Skin and Eye) (in vitro)
- Repeated Dose Toxicity (Oral, Dermal, Inhalation)
- Reproductive/Developmental Toxicity
- Genetic Toxicity
- Aquatic Toxicity (Fish. Algae, Daphnia)
- Daphnia Magna Reproduction Test
- Biodegradation Studies
- Adsorption and Desorption (Log KOC)
- Melting Point
- Boiling Point
- Water Solubility
- Solubility and Stability in Organic Solvent
- Vapor Pressure
- Flash Point
- Oxidation Properties
- Partition Coefficient
- pH Level
Cosmetic Product Notification
Cosmetic Product Notification: The cosmetic products which are being placed on the market should be notified and complied according to the regulation requirements. SSS has expertise in providing full service as per the regulatory requirements for cosmetic products.
All cosmetic products that will be placed on the market in the European Union need to be registered into CPNP prior to be placed. SSS provides service as a Responsible Person (RP) to notify your cosmetic product under CPNP.
We have done many CPNP notifications and helped our clients to fully comply the chemicals according to Cosmetic Product Regulation within EU.
SSS accompanies you in:
- Identification of cosmetic product.
- Checking various Negative/Positive lists.
- Notification to CPNP portal.
- Maintenance of Product information file and Product safety report.
- Testing requirements.
- Other compliance requirements.
SSS has helped many EU manufacturers/Importers to get compliance for their cosmetic products according to regulation and continues to provide this service.
The U.S. regulatory system for cosmetics was established in the year 1938, nearly 40 years before its EU counterpart and has evolved since then to meet changing requirements. The Federal Food, Drug and Cosmetic Act of 1938 (FDCA) granted broad authority to the Food and Drug Administration (FDA) to ensure that cosmetics are safe and truthfully labeled. Cosmetic companies may register in the United States through FDA’s Voluntary Cosmetic Registration Program (VCRP). The VCRP assists FDA in carrying out its responsibility to regulate cosmetics.
SSS can assist the client to fulfill the requirements of US-Cosmetic product notification for placing the product into US market.
In India, cosmetics are regulated by Central Drug Standard Control Organization (CDSCO) under the overarching regulation Drug and Cosmetic Act 1940 & Rules 19 (amended up to Dec.31st 2016). The Bureau of Indian Standards (BIS) issued standards for ingredient usage in cosmetics.
From April 1st 2013, all cosmetics imported for sale in India require mandatory registration with the Central Drugs General (India) (DCGI). For registration of imported cosmetic, a concept of “brand” is adopted and a brand will include all variant of products (color, shades, pack, sizes, etc.). Applicant should follow specific procedures of applications for any brands. Registered cosmetics are required to stick special label with registration certificate number on it, and normally the certificate is valid for 3 years.
Indian Chemical Regulations
Indian Chemical Regulations: In India, overall chemical regulation is not adapted, though the Food chemicals and agrochemicals along with certain defined hazardous chemicals, are regulated within different regulations.
Currently there is no Inventory of chemical substance available in India and the GHS based regulation is under its draft stage (dormant). Also Draft Chemical policy is available, but is yet not finalized.
Indian Chemical Industry, being one of the largest in the world, the Indian Government has also initiated plans to implement a REACH-like Regulation in India, in its effort to safeguard the country’s human health and environment. SSS has been able to contribute positively to these initiatives owing to the vast experience we have gained while working on the REACH Regulation for Indian companies, which has helped us to understand the Indian chemical industry and its trends.
SSS has been closely working with Indian Chemical Council (ICC) on the National Action Plan for Chemicals (NAPC) proposed by the Ministry of Environment, Forests and Climate Change (MoEF & CC) as well as with the Confederation of Indian Industry (CII) on the draft National Chemical Policy that is being developed by the Ministry of Chemicals and Fertilizers (MoC & F).
According to Insecticide/Pesticide Regulation, all insecticides (pesticides) have to necessarily undergo the registration process with the Central Insecticides Board & Registration Committee (CIB & RC) before they can be made available for use or sale.
SSS can help you to register your Insecticide/Pesticide under the regulation by evaluating various testing details (which is to be carried out) and submitting the information to Central Insecticides Board & Registration Committee (CIB & RC).
For the registration of any Pesticide/Insecticide following requirement needs to be fulfilled:
- Bio Efficacy
- Shelf Life Data
No goods of dangerous or hazardous nature to human life shall be carried by a common carrier (sea, land or air).
Our experts helped many clients for their business with the procedure and comply with such safeguards, which includes identifiers of the product, labeling, classification and packaging information of the dangerous products.
The Food Safety and Standards Authority of India (FSSAI) has been established under Food Safety and Standards, 2006 which consolidates various acts & orders that have hitherto handled food related issues in various Ministries and Departments. FSSAI has been created for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption. The Act aims to establish a single reference point for all matters relating to food safety and standards, by moving from multi-level, multi-departmental control to a single line of command. FSSAI requires registration certificate/License to be with food manufacturer or Importer with certain details and compliance requirements.
SSS can help small scale manufacturers and importers to Comply with FSSAI requirements.