General Overview

Lisam Systems Turkey Regulatory Services

Our regulatory consulting experts provide comprehensive support to ensure your company complies with local, regional, and global health and environmental regulatory requirements. These requirements impact your products today and will continue to evolve in the future.

As consumers and businesses increasingly prioritize safety and environmental responsibility, manufacturers, retailers, brand managers, traders, and distributors face growing regulatory pressures. Ensuring compliance not only avoids penalties but also builds trust and a competitive edge in the marketplace.

Key Regulations We Address

Lisam Systems Turkey specializes in helping companies navigate complex regulatory frameworks, including but not limited to:

  • KKDİK (Turkish REACH): Registration, authorization, and Only Representative services.

  • Turkish CLP (SEA): Classification, labelling, and packaging compliance for the Turkish market.

  • REACH (EU): Comprehensive compliance with EU REACH requirements.

  • CLP Regulation: Ensuring products meet classification, labelling, and packaging standards.

  • US TSCA (Toxic Substances Control Act): Compliance with U.S. chemical safety laws.

  • California Proposition 65: Addressing warnings for chemicals causing cancer, birth defects, or other harm.

Comprehensive Regulatory Services

Lisam Systems Turkey offers end-to-end regulatory solutions tailored to your business needs:

1. Identification of Applicable Requirements

  • Detailed evaluation of your products to determine specific regulatory, market, and customer requirements.

  • Monitoring sector and regional developments to anticipate regulatory changes.

2. Regulatory Strategy and Submissions

  • Development of a clear compliance roadmap aligned with your business goals.

  • Preparation of submission documents, including physicochemical, toxicological, and eco-toxicological assessments where required.

  • Support for complex waiver requests and scientific arguments (e.g., read-across).

3. Compliance Assurance Process Implementation

  • Design and implementation of tailored processes to ensure ongoing regulatory compliance.

  • Risk-based approach to proactively identify and address potential gaps.

4. Real-Time Regulatory Support

  • On-Call Consulting: Direct access to Lisam experts for immediate advice and troubleshooting.

  • Regulatory Q&A Support: Addressing detailed questions related to compliance strategies, substance evaluations, and specific regional requirements.

  • Information Change Notices (ICNs): Providing timely updates on changes to health and environmental requirements.

5. Human Health and Environmental Risk Assessments

  • Conducting in-depth hazard identification and risk characterization for human health and the environment.

  • Mechanistic evaluations to determine potential impacts of unique chemical hazards.

6. Product Safety and Efficacy Evaluations

  • Assessing safety, efficacy, and compliance of chemical substances, products, and mixtures.

  • Preparation of documentation to support product registrations and approvals.

7. Safety Data Sheet (SDS) and Exposure Scenario Authoring

  • Authoring and maintaining GHS-compliant Safety Data Sheets.

  • Developing exposure scenarios for substances under REACH and other regulations to ensure effective risk management.

8. KKDİK (Turkish REACH) Only Representative Services

  • Acting as an Only Representative for non-Turkish manufacturers to fulfill KKDİK obligations.

  • Liaising directly with Turkish authorities and managing the submission process.

9. Corporate Regulatory Training

  • Customized training programs to educate your team on regulatory obligations, compliance strategies, and industry best practices.

  • Addressing KKDİK, SEA, REACH, CLP, and other global requirements.

10. SIEF and Consortia Management

  • Managing participation in Substance Information Exchange Forums (SIEF).

  • Collaborating with consortia to streamline shared registrations and ensure compliance.

Why Partner with Lisam Systems Turkey?

At Lisam Systems Turkey, we combine technical expertise, industry know-how, and proactive strategies to deliver measurable results for your compliance needs:

  • Highly Skilled Experts: Our team consists of regulatory professionals, scientists, and risk assessors with in-depth knowledge of KKDİK, REACH, CLP, and other global regulations.

  • Independence and Solvency: As an impartial, financially stable partner, we prioritize your success with a focus on sustainable compliance.

  • Sector-Specific Solutions: Our tailored services address unique challenges across chemical, industrial, and product safety sectors.

  • Proactive Compliance Management: Real-time updates and long-term planning ensure you stay ahead of evolving regulations.

Benefits of Lisam Turkey's Regulatory Consulting

With Lisam Turkey’s regulatory services, your company can:

  • Manage Compliance Risks: Avoid regulatory penalties, product recalls, and supply chain disruptions.

  • Ensure Global Compliance: Align your products with international health and environmental regulations.

  • Develop a Competitive Edge: Enhance your market reputation with safe, compliant, and environmentally friendly products.

  • Minimize Business Impact: Reduce costs related to non-compliance, sales loss, and obsolete inventory.

  • Strategize Effectively: Prepare submissions, notifications, and documentation required for compliance.

Specialized Regulatory Areas

Our services address critical areas, including:

  • KKDİK (Turkish REACH): Registration, Only Representative, and Authorization support.

  • Biocides: Compliance for biocidal products under applicable laws.

  • CLP (Classification and Labelling): Accurate classification, labelling, and packaging of substances.

  • Safety Data Sheets: Authoring and maintaining up-to-date SDSs.

  • SIEF and Consortia Management: Efficient collaboration and cost-sharing for shared registrations.

  • Corporate Training: Building regulatory knowledge within your organization.

Addressing Emerging Challenges

Lisam Systems Turkey has consistently demonstrated its ability to adapt to new challenges, emerging regulations, and evolving formats. With our deep industry expertise, we help companies:

  • Stay informed of upcoming regulatory changes.

  • Implement solutions that align with global best practices.

  • Protect their operations from regulatory risks while enhancing long-term sustainability.

Take the Next Step Toward Compliance

Ensure your company is prepared to meet today’s regulatory requirements and anticipate tomorrow’s challenges. Partner with Lisam Systems Turkey to effectively manage compliance, minimize risks, and unlock growth opportunities.