Food

Full alignment with EU Regulation (EC) No 1924/2006, Directive 2002/46/EC, and Italian Legislative Decree 169/2004. We manage notifications to the Ministry of Health and ensure your products meet all compositional and labelling standards. Botanicals, including plant extracts and preparations, usually require a preliminary regulatory assessment, as they are subject to stricter national legislation than other food supplement ingredients.

Chemsafe supports companies across all regulatory pathways under Regulation (EU) 2015/2283, including full Novel Food authorizations, traditional foods from third countries notifications and modifications of authorized novel foods (e.g. extensions of use). We also assist with Novel Food status determination (i.e., the so-called "Art. 4 procedure") through the consultation process defined in Regulation (EU) 2018/456.

Our process begins with a data gap analysis to evaluate whether the available data meets the admissibility requirements for a Novel Food application. Missing information and recommended actions are consolidated into a feasibility study, providing a clear and strategic roadmap to compliance ready at the client's disposal.

While doing so, we also check the client compliance with the Transparency Regulation No 2019/1381 and the EFSA Notification scheme requirements through the EFSA Connect platform.

We then prepare and submit the Novel Food dossier via the European Commission (EFSC) platform, including a comprehensive scientific narrative with a literature review, a toxicological risk assessment, and a dietary exposure assessment, in line with European Food Safety Authority (EFSA) expectations.

Following submission, Chemsafe supports all post-submission activities, including managing requests for additional information from the European Commission and EFSA.

Chemsafe provides expert regulatory support in compliance with key European legislation, including:

• Regulation (EC) No 1332/2008 on food enzymes
• Regulation (EC) No 1333/2008 on food additives
• Regulation (EC) No 1334/2008 on food flavorings
• Regulation (EC) No 1331/2008 establishing a common authorization procedure

Our process begins with a data gap analysis to evaluate whether the available data meets the admissibility requirements for a Novel Food application. Missing information and recommended actions are consolidated into a feasibility study, providing a clear and strategic roadmap to compliance ready at the client's disposal.

While doing so, we also check the client compliance with the Transparency Regulation No 2019/1381 and the EFSA Notification scheme requirements through the EFSA Connect platform.

We then prepare and submit the Novel Food dossier via the European Commission (EFSC) platform, including a comprehensive scientific narrative with literature review, toxicological risk assessment, and dietary exposure assessment in line with European Food Safety Authoritya literature review, a toxicological risk assessment, and a dietary exposure assessment, in line with European Food Safety Authority (EFSA) expectations.

Following submission, Chemsafe supports all post-submission activities, including the management of requests for additional information from the European Commission and the managing requests for additional information from the European Commission and EFSA.

Chemsafe supports businesses in implementing and maintaining HACCP systems, helping identify potential risks, improve product quality, and meet regulatory requirements for food, chemical, and consumer product manufacturing. Chemsafe can also revise the existing HACCP plan and provide feedback on its completeness.

Quality Compliance services help companies ensure that products are manufactured safely, consistently, and in compliance with the EU food regulatory framework (Reg. 178/2002, Reg. 2017/625, Reg. 258/2004, Reg. 1935/2004).

We support companies in assessing and documenting packaging compliance under Regulation (EU) 2025/40 (PPWR). This includes evaluation of substance-related requirements, PFAS screening for food-contact packaging where applicable, heavy metals verification, recyclability and recycled-content assessments, and preparation of regulatory documentation for placing packaging on the EU market.

Our service supports food business operators in addressing PFAS-related risks, ensuring compliance with applicable EU legislation and recommendations from authorities such as the European Commission and the European Food Safety Authority (EFSA).

The process begins with a targeted gap analysis, aimed at evaluating available analytical data, supply chain information and existing documentation. This step identifies potential data gaps against current regulatory expectations, including monitoring requirements and risk assessment criteria. Findings and strategic recommendations are delivered through a tailored Feasibility Study.

Chemsafe then supports:

- PFAS occurrence assessment in food and food contact materials
- Dietary exposure estimation, aligned with EFSA approaches
- Toxicological risk characterization, including comparison with Tolerable Weekly Intake (TWI) values
- Supplier and raw material evaluation, to identify potential contamination sources

In regulatory complex contexts, including PFAS compliance, our chemical experts are willing to assist you in defining analytical testing strategies and interpreting laboratory results.
This service relates to the emerging PPWR regulation on packaging, which strongly controls the use of PFAS in food contact materials.

In the United States, any substance intentionally added to food must comply with specific FDA requirements before it can be marketed. In some cases, substances may qualify as GRAS (Generally Recognized as Safe), meaning they are considered safe for a specific use in food based on scientific evidence and expert evaluation.

Chemsafe helps companies assess GRAS status, draft GRAS dossiers for food ingredients, and navigate the regulatory process required to safely place products on the U.S. market in compliance with FDA requirements. Whether needed after the GRAS dossier is drafted, Chemsafe can convey a third-party Expert Panel (3 experts) to assess the GRAS conclusion in accordance with FDA requirements.

At the same time, Chemsafe can be part of an Expert Panel when needed from third parties, as Chemsafe experts are qualified to do so.

This service helps companies meet U.S. regulatory requirements applicable to dietary supplements and to new ingredients used in these products.

Chemsafe supports companies in the preliminary assessment of ingredients intended for use in dietary supplements in the United States, determining whether they qualify as Old Dietary Ingredients (ODI) or should be classified as New Dietary Ingredients (NDI).

For New Dietary Ingredients, Chemsafe provides support throughout the regulatory process: from DSHEA-based regulatory classification to scientific assessment, documentation review, and preparation of the dossier for the NDI Notification procedure, helping ensure alignment with FDA requirements.

The toxicological evaluation is essential to all foodstuffs. It can be the case of internal needs, for example, for using processing aids or assessing contaminants or Non-intentionally added substances (NIAS). Likewise, authorities can request an extra toxicological evaluation post-submission or under certain circumstances. At Chemsafe, our ERTs® (European Registered Toxicologists) verify and sign all our toxicological reports.

Chemsafe provides expert support in the design and management of experimental studies to assess the potential toxicity of substances used in food and related applications.

Experimental data are often essential to generate robust scientific evidence and enable a reliable toxicological risk assessment. Depending on the regulatory context and data requirements, this may include both in vitro and in vivo studies, designed to investigate specific toxicological endpoints. Usually, these are study according to OECD Guidelines such as OECD 432 (acute toxicity), OECD 408 (repeated toxicity), OECD 471 (AMES test), OECD 487 (in vitro MNT test).

Chemsafe assists clients throughout the entire study design phase, ensuring that testing strategies are scientifically sound and aligned with current regulatory expectations and international guidelines.

In silico toxicology methods are widely used to assess the mutagenic and genotoxic potential of chemicals under international regulatory frameworks. These advanced computational models analyze molecular behavior to accelerate, support, or replace traditional in vitro studies, reducing both time and costs.

Using validated databases and QSAR (Quantitative Structure–Activity Relationship) technologies, Chemsafe provides predictive assessments through:

DEREK Nexus – Toxicology Prediction
SARAH Nexus – Genotoxicity Prediction
METEOR Nexus – Metabolism Prediction
ZENETH Nexus – Degradation Product Assessment

Expert interpretation and scientific reports by our ERTs® are also available.

We support manufacturers in the early evaluation of recycled plastics intended for food contact materials (FCMs), in line with Regulation (EU) 2022/1616.

Our service includes:

- Assessment of the production process and recycling technology
- Evaluation of input materials (waste streams) used as starting material
- Identification of potential chemical and microbiological hazards

We then carry out a risk assessment based on realistic use conditions and exposure scenarios, ensuring that recycled plastic products are not only compliant, but demonstrably safe.

Our feasibility studies provide early-stage regulatory insight to streamline your path to market. We can help you.

• Clarify the regulatory status of your product, ingredient, or food contact material (including novel food qualification where relevant)
• Identify applicable regulatory and scientific requirements for market access
• Perform a structured data gap analysis to highlight missing studies, data, or documentation
• Define a clear, tailored strategy with timelines, costs, and next steps

By managing borderline and non-standard products with expertise, we simplify your regulatory journey by reducing costs, avoiding rework, and accelerating time-to-market.

Have you already discussed it with your AI agent or internal chatbot? We don’t blame you! We review AI-generated outputs too. AI is a powerful support tool, and can enhance expert experience.

Following the Three Rs principle (Replace, Reduce, Refine), we prioritize existing scientific evidence to optimize regulatory strategies while reducing unnecessary testing.

Our multidisciplinary team performs comprehensive data gap analyses and systematic literature reviews to assess the completeness of your data package against current regulatory requirements. By critically evaluating published scientific evidence, authoritative databases, and existing studies, we identify missing information, support safety assessments, and define the most efficient pathway to compliance.

The result is a science-driven regulatory strategy that strengthens your dossier, reduces development risks, and accelerates regulatory decision-making.