REACH CERTIFICATION
What is REACH?
REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.
In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture, and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.
REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users.
Benefits of REACH Certification
Protection of human health
Product Reliability
Better business opportunities and revenu
Improve Environment
It supports to progress brand image and market value of the organization.
Continual Business Improvements
Who can be certified REACH Certification?
Manufacturers and importers have to apply for a REACH certificate or a registration number when they use or bring into circulation materials that are subject to the REACH Regulation.
Chemical Products
Chemical Substance
Chemical Mixture
Document required for REACH Certification
- Technical File, Product Master File (TCF)
- Product Testing
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Plant Master File
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Product and it's uses
- Testing requirement of products
- Directive in which product classified
- Self Certification or Compliance Certification
- Notify body Certificate
Role of Shamkris and Process of REACH Certification
Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives.
The implementation process is described below:
Time Frame
Task
Process
Day 1
Scope defined
Self Certification/NoBo
Selection
Cost Estimates
- Finding directive and EN standard applicable to the product
- Selecting the appropriate certification scheme
- Based on the scope of the product and certification scheme
Week 1
Developing Documents
- Technical file, Plant Master file and Test Protocol
- Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
- Review of Standard Operating Procedures (SOP)
Week 4
Implementing Product Management System
- REACH Awareness training to QC manager and Production Manager
- Implementing a well-documented manual throughout the life cycle of the product
Week 8
Internal Audit
MRM
CAPA
- Internal audits identifying nonconformities related to REACH requirements
- Management Review Meetings
- Corrective and Preventive Action plan for nonconformities
Week 10
Self Certification/NoBo
Audit
N-C Closing
- Shamkris acts on your behalf and assists you in the third-party audit
- Closing of any nonconformities identified by the Self Certification/NoBo
Week 12
Self Certification/NoBo
- REACH certificates issued for 5 years or each project
- Surveillance Audits yearly
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
FAQ
Registration, Evaluation, Authorization, and restriction of Chemicals (REACH)
Is REACH Compliance Mandatory? U.S. companies that export to the EU have registration and authorization requirements to meet REACH compliance. Failing to adhere to REACH chemical compliance regulations could result in your company being shut out of the EU.
Why is REACH compliance important? Compliance to REACH allows companies to: Prove they are safeguarding human health and the environment. Access the EU market.