EU Biocide Regulation Changes: What Fuel Operators Must Know
If you use a fuel biocide to protect stored or bunkered diesel from microbial contamination, the regulatory ground underneath that treatment is shifting. The EU Biocidal Products Regulation - Regulation (EU) 528/2012, the BPR - has always contained exclusion criteria for the most hazardous active substances, but the review programme that evaluates which actives meet those criteria is now producing decisions that directly affect the fuel treatment sector.
For operators running on a widely used marine diesel-biocide active that has been classified carcinogenic category 1B, the question is no longer theoretical. This article explains the framework, what Article 5 requires, how Product Type 6 (fuel preservation) sits within it, and what a compliance-sound procurement decision looks like. It is part of our complete guide to fuel biocides and EU regulation.
The BPR in brief: how EU biocide rules work
The EU Biocidal Products Regulation - Regulation (EU) 528/2012 - governs the placing on the market and use of biocidal products across the European Economic Area. Its central mechanism is a two-tier approval system: first, the active substance in a biocidal product must be evaluated and approved for the specific product type in which it is used. Only then can the biocidal product containing that active be authorised for sale and use.
The regulation covers 22 product types (PTs) grouped across four main areas: disinfectants, preservatives, pest control and other biocidal products. Fuel biocides fall under Product Type 6 (PT6) - preservatives for products during storage: products used to preserve manufactured products, other than food, feed, medicines or cosmetics, by controlling microbial attack during storage.
For an active substance to be used in a fuel biocide in Europe, it must be included in the BPR review programme for PT6, evaluated by a member state competent authority, reviewed by ECHA's Biocidal Products Committee, and approved by Commission Implementing Regulation. An active not approved for PT6 cannot lawfully be the basis of a fuel biocide placed on the EU market.
Article 5: the exclusion criteria
The most consequential part of the BPR for fuel operators is Article 5, which sets out the hazard-based exclusion criteria - a list of substance properties that, in principle, disqualify an active from approval entirely.
Under Article 5(1), the following shall not be approved:
- Active substances classified as carcinogen category 1A or 1B under Regulation (EC) 1272/2008 (CLP);
- Active substances classified as mutagen category 1A or 1B;
- Active substances classified as toxic for reproduction category 1A or 1B;
- Active substances identified as endocrine disruptors for humans;
- Active substances that are PBT or vPvB (persistent, bioaccumulative and toxic / very persistent and very bioaccumulative).
These are described as "exclusion criteria" because they trigger exclusion from approval in principle. The rationale is straightforward: substances of very high concern should be phased out over time and replaced by safer alternatives.
Article 5(2) does allow for limited derogation - an excluded active may still be approved if the risk is negligible (e.g. in closed systems), if the substance is essential to prevent a serious danger, or if non-approval would have a disproportionate negative impact on society. But any such approval is capped at five years, and the approved product is flagged as a candidate for substitution.
Why a widely used marine diesel-biocide active is now restricted
One of the most widely used active substances in marine diesel biocides - a product type that has been standard issue on vessels and in offshore facilities for decades - has received a harmonised classification as a carcinogen category 1B under the CLP Regulation. That classification triggers the Article 5 exclusion criteria directly.
Under EU REACH (Regulation (EC) 1907/2006, Annex XVII), substances classified as carcinogen 1A or 1B are restricted from supply to the general public at concentrations above 0.1%. The REACH restriction reached commercial users first in the form of supply-chain tightening - some products containing this active became available only to professional users, and procurement became more complicated for smaller operators and leisure users.
The parallel BPR process - the formal review of the active substance under the BPR review programme for PT6 - means the question of whether it can remain an approved active for fuel preservation is now subject to regulatory decision. Products built on a carcinogen 1B-classified active face the Article 5 exclusion test; any approval is conditional and time-limited, not a stable long-term basis for procurement planning.
This creates a specific risk for operators: a biocide that a vessel or facility has relied on for years may become difficult or impossible to source compliantly, within the regulatory timetable - not because of any operational failure, but because the regulatory framework has caught up with the active substance's classification.
What the review programme means in practice for PT6 actives
The BPR review programme was established to systematically evaluate all active substances already on the market when EU biocide legislation was first adopted. ECHA manages the programme; evaluating competent authorities in member states conduct the assessments. The Standing Committee on Biocidal Products - the formal decision-making committee at the European Commission - receives draft implementing regulations and implementing decisions and votes on approvals, renewals, non-approvals and postponements.
The June 2025 minutes of the 88th meeting of the Standing Committee illustrate the active state of these decisions: the meeting covered draft implementing decisions including on CMIT/MIT product family authorisations, postponements for multiple actives, and a range of product-type-specific approvals and non-approvals. The programme is a live process, not a historical exercise.
For fuel operators, the practical implications are:
- Active substances not (or no longer) approved for PT6 cannot be the basis of a legally placed fuel biocide in the EU. When an active's approval lapses or is not renewed, products containing it must typically be removed from the market within 12 months.
- Products authorised under a conditional derogation (Article 5(2)) are candidates for substitution. Member state authorities conducting comparative assessments must consider whether alternatives with a better hazard profile are sufficient to substitute the derogated active.
- Procurement decisions made now will play out through the regulatory timetable. An operator purchasing a biocide built on a restricted active is making a decision that may require re-procurement within the approval window.
Product Type 6 and what approval looks like for a compliant active
For a fuel biocide to be compliantly placed on the EU market, its active must be approved specifically for PT6. The approval process confirms that the active is effective for the PT6 use case - preserving liquid hydrocarbon fuel in storage against microbial attack - and that, subject to any conditions, it does not meet the exclusion criteria, or that a valid derogation applies.
One active that has gone through this process and received full PT6 approval without triggering the Article 5 exclusion criteria is C(M)IT/MIT - 5-chloro-2-methyl-3(2H)-isothiazolone and 2-methyl-3(2H)-isothiazolone in a 3:1 ratio - approved under Commission Implementing Regulation (EU) 2016/131 for product types including PT6. Chronic studies of C(M)IT/MIT show no evidence of carcinogenicity, and independent risk assessments have concluded it is not a carcinogen. This means it does not carry the Article 5 classification risk that applies to the restricted marine diesel-biocide active discussed above.
Fuelcare's FuelClear™ M15 is built on C(M)IT/MIT - BPR PT6-approved, documented as non-carcinogenic, and holding a NATO Stock Number for naval applications. It is available on fast lead times from Fuelcare's EU distribution hub in Venlo, Netherlands, which means compliant product can reach European operators quickly - a material advantage when curative treatment needs to happen before a vessel sails.
The double exposure: contamination risk and compliance risk
For operators using a fuel biocide based on a carcinogen 1B-classified active, the position is straightforward but uncomfortable: there is a contamination risk if treatment stops (stored and bunkered diesel will develop microbial contamination), and a compliance risk if treatment continues on an active that is heading for restriction.
The only way to resolve this double exposure cleanly is a switch to a compliant alternative - one that is effective, BPR PT6-approved, and built on an active that is not caught by the Article 5 exclusion criteria. That means acting before the supply chain is disrupted, not after.
The regulatory timetable is not predictable in its precision - approvals can be extended, decisions can be deferred - but the direction is clear and has been moving in one direction for several years. Operators who plan procurement around compliance rather than waiting for disruption are in a materially better position.
What to do next
If you are currently using a marine diesel biocide, or managing stored diesel that requires treatment, the practical checks are:
- Identify the active substance in your current biocide. Ask your supplier for the Safety Data Sheet and confirm the active substance. Check whether it carries a carcinogen 1A/1B classification under the CLP Regulation.
- Confirm PT6 approval status. Verify that the active is currently approved for PT6 under the BPR and check for any conditions or time limits on that approval.
- Evaluate compliant alternatives. A BPR PT6-approved product built on an active that does not meet the Article 5 exclusion criteria (not classified CMR 1A/1B) is a stable basis for procurement planning.
- Act before supply is disrupted. Procurement that anticipates the regulatory direction avoids searching for compliant product under time pressure.
Not sure whether your current treatment is compliant? Speak to the Fuelcare team about a fuel test and a compliant, in-stock alternative - call +44 (0)1743 360784 or email sales@fuelcare.com.
Frequently asked questions
What is the EU Biocidal Products Regulation (BPR)?
Regulation (EU) 528/2012, the BPR, governs the making available on the market and use of biocidal products across the EU. It requires active substances to be evaluated and approved for specific product types before they can be used in biocidal products placed on the EU market.
What does Article 5 of the BPR require?
Article 5 sets out exclusion criteria: active substances classified as carcinogens, mutagens or toxic for reproduction (category 1A or 1B), or identified as endocrine disruptors, PBT or vPvB, shall not in principle be approved. A limited derogation is possible in specific circumstances, but approval under derogation is capped at five years and the product is a candidate for substitution.
What is Product Type 6 (PT6) and why does it matter for fuel biocides?
PT6 covers "preservatives for products during storage" - which includes products used to control microbial contamination in stored liquid hydrocarbon fuels. A fuel biocide active must be approved specifically for PT6 to be used lawfully in a fuel biocide placed on the EU market. Approval under another product type does not cover fuel use.
Is C(M)IT/MIT approved under the BPR for fuel biocide use?
Yes. C(M)IT/MIT was approved for PT6 under Commission Implementing Regulation (EU) 2016/131. Chronic studies show no evidence of carcinogenicity and independent risk assessment concludes it is not a carcinogen - meaning it does not trigger the Article 5 exclusion criteria applicable to carcinogen-classified actives.