Engineering & Compliance Solutions
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Compliance Services we offer
IMDS/ CDX
The International Material Data System (IMDS) is a global data repository for automotive industry
International Material Data System
The International Material Data System (IMDS) is a global data repository which contains information on materials used by the automotive industry. It is primarily used to meet obligations set by GADSL, ELV etc.
What we do?
1. Company registration in IMDS web portal.
2. Creation of MDS for materials based on BOMs, drawings and other specification.
3. Request, Send/ Propose of MDS to OEM and other Suppliers.
4. Receiving / Validating MDS as per ELV, GADSL, REACh, RoHS, OEM specific standards etc. from suppliers/ sub suppliers through follow-up.
5. Percentage calculation of substances in Material/ Product level based on the requirements of OEM and Suppliers etc.
REACh
Registration, Evaluation, Authorization and restriction of Chemicals is an EU law under ECHA
REACh
Registration, Evaluation, Authorization and restriction of Chemicals is an EU directive (ECHA) that regulates manufacturing and imports of products containing SVHC in EU market
What we do?
2. Authorization list (Annex XIV): Substances in this list are provided with sunset date by ECHA, from then the manufacturing of the substance is prohibited.
3. Restriction List (Annex XVII): Substance in this list is prohibited for specific application, placing of such substances are prohibited within the EU market.
4. Interaction with suppliers in getting updated MDS and confirmation on the usage of Substances of very high concern (SVHCs) and many more
RoHS
Restriction of Hazardous Substance directive is an EU framework to regulate electronic equipment.
RoHS
Restriction of Hazardous Substance directive is an EU framework to regulate the use of hazardous substance in electrical and electronic equipment. Currently, the directive consists of 10 substances which are allowed to use only under specific threshold limit. The restriction is applicable for 11 categories of electrical equipment.
What we do?
2. Assisting suppliers in complying with RoHS regulations.
3. Supplier interaction to ensure the sharing of compliant data throughout the supply chain.
4. Any specific information related to RoHS based on the customer requirement.
EU MDR
EU MDR is a regulation on clinical investigation & sale of medical devices for human use
EU MDR
EU MDR is a regulation on clinical investigation & sale of medical devices for human use. It repeals Directive 93/42/EEC, which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021
What we do?
2. Assisting suppliers in complying with EU MDR regulations.
3. Collecting EU MDR Declarations/ Certificate of Conformity from global suppliers.
4. Any specific information related to EU MDR based on the customer requirement.
Prop65
Prop 65 requires entities to provide warnings to Californians about exposures to chemicals
California Proposition 65
Safe Drinking Water and Toxic Enforcement Act of 1986 also known as California Proposition 65 requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm. The acts list a set of chemicals which comes under the regulatory watch prop65. The act also requires businesses to explicitly label their products with a standard warning message. Non compliance to such regulation will impose hefty penalties to the respective company.
What we do?
1. Supplier collaboration to confirm the usage of Prop65 substances in the products
2. Reporting of Prop65 substances to the customer.
3. Ensuring the prop65 products are in compliant as per the regulations.
Conflict Minerals
Conflict resources are naturally extracted in a conflict zone and sold to perpetuate the conflict
Conflict Minerals
Conflict resources are natural resources extracted in a conflict zone and sold to perpetuate
the conflict. The Minerals include Tin, Gold, Tungsten & Tantalum and Cobalt.
(3TG, Mica & Cobalt)
The US and EU mandates their companies to should disclose if they used conflict
minerals in their products. The law is in effect in US and will be will be implemented from
January 2021 in EU
What we do?
2. Ensuring the products country of origin from suppliers
3. Conflict Minerals Reporting Template (CMRT) & Cobalt Reporting Template (CRT) preparation
4. Ensuring proper dissemination of information throughout the supply chain related to conflict minerals.
SCIP
SCIP database mandates companies that market an article containing an SVHC more than 0.1%
SCIP Database (Substance of Concern in Products)
As a part of EU Waste Framework Directive, European Chemical Agency (ECHA) has recently published detailed information requirements for the SCIP (Substance of Concern in Products) database, which entails increased obligations for companies that market an article containing an SVHC of candidate list above 0.1% in the EU.
What we do?
2. Analysis of SVHC Candidate list substance and its concentration as per REACh regulations
3. Dossier creation and submission of SVHC substances in ECHA portal for evaluation
4. Any customer specific requirement related to SCIP
POP & BPR
BPR regulates the usage
of biocides and POPs are organic substances that persist in the environment
POP & BPR (Persistent Organic Pollutants & Biocidal Products Regulations)
The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) regulates the usage
of biocides that protects humans, animals, materials or articles against harmful organisms
like pests or bacteria.
Persistent organic pollutants (POPs) are organic substances that persist in the environment,
accumulate in living organisms and pose a risk to our health and the environment.
POPs which are prohibited India are also included.
What we do?
2. Any customer specific requirement related to POP and BPR substances
Global Compliance Regulations
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What we do?
We offer product & regulatory compliance for automobile, aerospace, Electrical & Electronics, Chemical manufacturers, and medical device manufacturers to make their products compliant with global regulations that include IMDS/ CDX, CAMDS, REACh, RoHS, GADSL, SDS & CLP, EU-ELV, POP, EU MDR, ADM, Conflict Minerals, Prop65, and other Environmental Regulations.
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