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Regulatory Compliance

Our knowledge of the applicable regulations and our experience with the required testing allow us to support you through every step of the documentation for Food Contact/MOCA and REACH.

We help you define and draft technical documentation that is precise, clear and complete.

When instrumental analyses are needed, although we do not carry them out ourselves, we coordinate our partner laboratory and provide an interpretation of the results, turning them into information you can use for your submissions. At the same time, we work to keep the number of tests to a minimum, so you avoid unnecessary costs.

In practice, we:

  • identify the applicable regulatory requirements;
  • define the necessary tests;
  • coordinate the analyses with our partner laboratory;
  • interpret the chemical and technical data;
  • draft the technical documentation for your submissions;
  • also help you keep your regulatory knowledge up to date.

Compliance is not achieved with a test. It is built at the drawing board, before the product even exists. The wrong choice of raw materials, incomplete characterisation or a superficial assessment of the applicable legislation can lead to delays, extra costs or even a block on market access. We step in from the earliest stages of development, turning complex analytical data into clear and timely operational decisions.

REACH – Reg. (EC) No. 1907/2006

Compliance as a starting point, not as a finish line.

The REACH Regulation does not apply to polymers as such, but to the substances they are made of, to additives and to impurities. That is why we check for SVHCs (Substances of Very High Concern) along the entire supply chain of the raw materials you use.

We support you in reviewing supplier documentation, assessing safety data sheets and defining the information needed to ensure compliance. When instrumental analyses are required, we coordinate our partner laboratory and interpret the results, turning them into practical guidance for your supply chain.

In practice, we:

  • identify substances subject to restriction or authorisation (SVHC, Annex XIV, Annex XVII);
  • verify the documentation provided by your suppliers;
  • define the necessary tests and coordinate the analyses with our partner laboratory;
  • interpret the results and support you in communicating along the supply chain.

Beyond REACH

Legislation on polymer materials evolves quickly. That is why our consultancy covers the entire regulatory framework of the product and of its target market.

Area

What we do

Why it helps

Food Contact, Cosmetics and Pharmaceuticals

We define testing plans with compliance studies and risk assessment according to European and US legislation and international guidelines.

We avoid unnecessary tests and give you certainty on market access.

NIAS assessment

We analyse non-intentionally added substances (NIAS) with a TTC approach (Cramer classes) and “in silico” toxicological assessments through recognised databases.

We anticipate risks that would otherwise emerge only after launch.

PPWR – Reg. (EU) 2025/40

We support you on the new packaging requirements: recyclability, recycled content, sustainability and eco-design.

We get you ready for the new rules before they become mandatory.

Recycled materials in contact with food

Consultancy on compliance with Reg. (EU) 2022/1616 on plastics for food contact.

We open the door to the circular economy, safely.

Regulatory monitoring

We follow the evolution of European and international legislation to keep your products up to date over time.

You will never be caught out by a change in the rules.