New contaminants legislation

“Substantively, no completely new subject categories were introduced,” state Hans van der Moolen and Fenny Kint, Contaminants Experts at Eurofins Food Safety Solutions and Eurofins Lab Zeeuws-Vlaanderen. “The main updates focus on structure, sequencing, and clarifying definitions, leaving less ambiguity for divergent interpretations.” Where will you notice the most significant impact? Van der Moolen and Kint highlight the key updates below.

Structure and sequencing

1. Footnote integration: The previous regulation relied heavily on footnotes. In the new legislation, these conditions have been integrated directly into the tables for greater clarity.

2. The ALARA principle: Contaminant levels in your product must now strictly adhere to the ‘As Low As Reasonably Achievable’ (ALARA) principle. This means food business operators must implement good practices to prevent contamination across all stages; merely staying below the legal maximum level is no longer sufficient on its own.

3. Reordered articles: The overall order of articles has changed, and certain internal paragraph sequences have been restructured.

4. Lower-bound concentrations for sums: For contaminants calculated as a sum, maximum levels refer to lower-bound concentrations. Lower-bound concentrations are calculated assuming that all values below the limit of quantification (LOQ) are zero. For example, if you calculate the sum of 4 components—such as Aflatoxins B1, B2, G1, and G2—and only 2 are quantified while the other 2 are below the LOQ, you set the remaining two values to zero. While standard in industry practice, this is now formally codified in law, preventing disputes over test results near the limit.

5. Alignment with pesticide categories: Food categories in this contaminants legislation align more closely with commodity classifications in pesticide residue regulations. Corresponding product listings now exist for nuts, oilseeds, and spices, removing previous classification ambiguities and clearly defining applicable limits.

6. Ban on detoxification expanded: The prohibition on chemical detoxification previously applied solely to foodstuffs listed in Section 2 of the Annex (mycotoxins). Under Article 4 of the new regulation, this ban applies across all food categories in Annex I, as scientific uncertainty remains regarding toxic metabolites that may form during chemical detoxification.

Processed and compound products

1. In the previous regulation, specific criteria for processed or compound products were less defined. Under the current framework, compliance is evaluated based on the relative proportions of ingredients in the recipe. Specific concentration, dilution, and processing factors must still be factored in, as processing can alter contaminant concentrations. You must be able to provide these exact recipe proportions and processing factors to the NVWA upon request. This can prove challenging for retailers outsourcing private-label manufacturing across extensive product lines. If an individual raw material or ingredient exceeds its respective maximum level in Annex I, it may not be placed on the market or used as a food ingredient.

2. The 80% rule: If a food product consists of more than 80% of a single ingredient, the maximum level set for that ingredient applies to the finished compound product as well. For example, peanut butter containing 87% peanuts is subject to the statutory limits for raw peanuts: 2.0 µg/kg for Aflatoxin B1 and 4.0 µg/kg for total aflatoxins. This principle applies equally to cereal-derived products containing at least 80% cereal components.

3. Arsenic updates: Maximum levels for inorganic arsenic were revised for non-parboiled milled rice (white rice), rice flour, and rice-based non-alcoholic beverages. Fruit juices and salt were newly added to the arsenic limits table (originating from the March 3, 2023 amendment to the former regulation, incorporated into Regulation (EU) 2023/915).

Changes to previous maximum levels

For most product matrices, existing maximum levels remain unchanged. Targeted adjustments apply to specific items, such as instant coffee and infant formula.

Navigating contaminants legislation: a complex task

Safeguarding food safety across supply chains presents ongoing operational challenges. Kint: “Contaminants legislation represents just one part of the wider compliance landscape. Supply chain traceability and transparency are essential for accurate risk profiling. Conducting a solid risk assessment leads directly to an effective monitoring plan. In the Netherlands, NVWA Information Sheet 64 (Informatieblad 64) provides useful guidance for verifying compliance. An experienced quality team is critical, which is why we support clients in designing comprehensive, audit-ready monitoring plans.”

Risk assessments under the ALARA principle

“A standard risk assessment should not require fundamental overhaul under the new regulation, as it already forms the basis of any monitoring schedule,” Van der Moolen notes. “However, verify that adherence to the ALARA principle is explicitly documented in your risk assessments and quality systems. Monitoring plans for compound foods, instant/soluble coffee, and infant nutrition will require the most updates.”

Exceeding a limit? Review supply chain data

When an analytical exceedance occurs, investigating supply chain traceability data is the first step. Kint: “If your facility operates at Step 5 in the supply chain, having detailed data from upstream tiers is vital—particularly for origin-dependent contaminants. Heavy metals naturally reside in soil, meaning spinach sourced from one agricultural region may carry higher heavy metal loads than spinach grown elsewhere.” Processing steps are another primary contamination vector. Van der Moolen: “Consider food-grade machinery lubricants or process contaminants generated during baking, roasting, or smoking. Gather as much technical data as possible regarding the geographic origin and manufacturing process of your raw materials, ingredients, and semi-finished goods.”