Providing excellence in European Regulatory Affairs

Regulations governing the import, export and manufacture of specialty chemicals and ingredients change frequently depending on the market. No two markets are the same and what is applicable in one market may not be in another. It is therefore very important to be aware of any changes in regulations in order to stay ahead and avoid inevitable disruption to the supply chain.

Regulatory matters are, however, highly time-consuming and distract companies from focusing on their core competences. By partnering with an experienced and well-established regulatory expert, companies can fully support with a range of tailored services, including supply chain compliance, product registration, supply qualification and regulatory consultancy.

To make life easier for you, we set up DKSH’s ERAC3 (European Regulatory Affairs Compliance Competence Center). In ERAC3 our specialists work around the clock to support you with all regulatory matters in the specialty chemicals and ingredients distribution business. We help companies to ensure compliance and maintain a robust and sustainable business. With us, you are in safe hands.

Your regulatory experts: ERAC3

Founded in 2009 in Lyon, France, ERAC3 was established to ensure conformity to all safety, quality and regulatory standards, laws and regulations for the business activities of DKSH’s Business Unit Performance Materials in Europe.

By ensuring compliance, ERAC3 maintains absolute business continuity for DKSH’s business partners. ERAC3 is also closely connected with the vast network of DKSH Regulatory Affairs centers around the world and has proven to be the cornerstone of expertise in regulatory affairs matters at DKSH.

In 2019, the team celebrated ten years of providing support and excellence in regulatory affairs.

DKSH provides crucial support in all regulatory and registration matters for its business partners in the following key industries:

Specialty Chemicals Industry
Personal Care Industry
Pharmaceutical Industry
Food & Beverage Industry

How ERAC3 supports you

ERAC3 has three main divisions:

  • Safety, Health and Environment (SHE): responsible for all safety aspects of your chemical or ingredient business, including Safety Data Sheet and Dangerous Goods management
  • Quality (QA): responsible for continuous improvement of quality management system and processes
  • Regulatory (REG): responsible for registrations and regulation compliance of the chemicals and ingredients we distribute
ERAC3 set-up

REACH is the European Union’s regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals and is therefore a key focus of ERAC3.

The implementation of the REACH regulation within DKSH was achieved progressively. As ERAC3 acquired more and more knowledge, experience and expertise of the regulation, DKSH hired new talents to structure and work on a daily basis with authorities, customers and clients. The required expertise and resources for maintaining the compliance level and the workload are regularly reviewed and assessed.

ERAC3 is responsible for training and communicating with DKSH’s employees, including sales managers, sales support and business leaders, on all regulatory matters concerning their area of responsibility. As the European chemical market becomes more and more regulated, a consistent line of communication to update all personnel on changes is essential. It also allows DKSH to pass on invaluable knowledge to its business partners.

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Not yet REACH compliant? Here’s what you need to know

Getting to grips with K-REACH compliance

How to navigate the China REACH regulation

REACH compliance

Within each of our markets, external communication is the responsibility of the Local Regulatory Affairs Managers, as well as the Sourcing Managers (for clients) and Sales Managers (for customers).

Members of ERAC3 have direct contact with both clients and customers to provide crucial technical support. This allows us to efficiently obtain the latest chemical testing data and required documentation from both parties in preparation for compliance reviews.

Ensuring compliance

ERAC3 continues to assess the regulatory compliance of existing and new substances within the DKSH portfolio by:

  • Creating master material data
  • Checking if any Only Representative is in place for non-EEA manufacturers
  • Checking for cases of REACH exemptions (food/feed, pharmaceuticals, natural origin, …)
  • Monitoring substances of Very High Concern (SVHC)
  • Monitoring the quantities of REACH relevant substances imported into EEA
  • Classifying all chemical substances according to CLP regulation (EC)
  • Notifying ECHA (the European Chemicals Agency) and EU member states authorities of all hazardous substances and products
  • Checking and maintaining the Safety Data Sheets for all products
Continued monitoring

Did you know?

  • ERAC3 has helped over 400 companies to register over 80 substances under the REACH regulation
  • ERAC3 pre-registered more than 900 substances before the REACH regulation deadline of May 31, 2018 (and has “late pre-registered” hundreds more)
  • ERAC3 defines a registration strategy for every single substance it registers
  • ERAC3 uses digital tools to administer a complex internal system of documents and for communications purposes
DKSH France, Lyon

Q&A Interview with Joaquim Pires, Director, Regulatory Affairs

Joaquim Pires

What’s it like to work for  ERAC3?

I consider myself as a facilitator between our sales force, customers, clients from one side and my team specialists on the other side including also the global DKSH regulatory team in place worldwide.

What’s the most difficult part of your job?

At ERAC3 we handle a tremendous variety of safety, quality and regulatory topics and I have to admit it is quite a challenge to be updated as an expert in all these domains.

What do you enjoy most?

Collaborative work especially when our customers and/or suppliers are involved.

What is the most significant change you have seen in the chemical industry in recent years?

Regulatory requirements are constantly changing and becoming more complex. At same time and for this reason, customers are in seek to ensure compliance with more regulatory requests and expecting instant answers. Digital transformation is on the way!

What advice can you give to companies looking to register substances in Europe?

Search for the best experts who can give pragmatic advice to fit your company needs in terms of registration according to the expected business.

Jean Dominique Foulon

“After ten years, ERAC3 continues to provide excellent value-added services to DKSH clients and customers.

Our team of specialists gives the guarantee, as a performance materials distributor, that we know and we care products we distribute in accordance with all safety, quality and regulatory standards, guidelines, laws and regulations.

We look forward to the next decade of ERAC3 and beyond!”

Jean-Dominique Foulon, Managing Director, DKSH France

Contact us We are ready to support you with your regulatory affairs needs!

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