Recycled Content Exemptions and Derogations: The Real List

Article 7's relief comes in three shapes. Built-in exclusions: plastic parts forming less than 5 percent of a unit's total weight sit outside the calculation, and the targets do not apply to compostable plastic packaging, which is governed by its own logic. Category derogations: defined cases, concentrated in medical devices, medicinal products and certain contact-sensitive applications, where recycled content conflicts with safety or authorisation requirements, relieved through the article's procedures. And a market derogation mechanism: where feedstock availability or price disruption is demonstrated, the Commission may adjust application for affected categories through the article's review machinery.

Each shape carries its own discipline, and none of them is a general small-line or small-business exemption. The foundations station's rule holds here in its purest form: claim per provision, on facts, in the file.

The medical logic is authorisation integrity. Packaging for medicinal products forms part of a marketing authorisation; its material is specified, validated and stability-tested, and substituting feedstock is a regulatory variation with patient-safety review attached. Medical devices carry parallel constraints through their own regulation. Article 7's treatment recognises that a content mandate cannot silently override a safety authorisation, and provides derogated positions for defined categories - including packaging in direct contact with medicinal products and specified device packaging. Manufacturers in this space should map each line to its authorisation position first: lines whose packaging is authorisation-locked belong in the derogation conversation with regulators early, because the variation pathway and the derogation pathway run on different clocks and both are slow.

The parts exclusion is arithmetic mercy for caps, valves, seals and labels, and the granularity guide in the formats station owns its correct use: per part, against total unit weight, never aggregated. Two audit patterns to avoid. Designing a functional part to land at 4.9 percent by adding mass elsewhere in the unit - the calculation's basis is examinable and the manoeuvre reads as what it is. And treating the exclusion as evidence relief: an excluded part still sits inside the substance limits and the grade assessment; it is only the content percentage that does not reach it. Files should show the exclusion calculation expressly wherever it is relied on, so its honesty is visible rather than inferred.

The availability mechanism exists for genuine market failure - a category whose post-consumer supply demonstrably cannot form at the mandated scale, or whose price dislocates beyond the article's thresholds. Its characteristics define its use. It is granted by decision, for a category, for a period: nobody's individual entitlement. It follows evidence and review, which means it arrives, if at all, close to the date it relieves. And it can be conditioned or partial. A programme that assumes the valve will open has outsourced its plan to a committee. The professional position is to build to the target, monitor the review evidence for your category as a tracked risk, and treat any derogation granted as recovered time to finish the supply build - which is what the mechanism, read fairly, is for.

Wherever relief is relied on, the file carries four entries: the provision, the facts meeting its conditions, the evidence for those facts, and the review date on which the reliance is re-examined. Derogations and exclusions decay: authorisations vary, product designs change, market decisions expire. A reliance recorded with its review date is a managed position; a reliance remembered as 'we are exempt' is a future finding with the date left blank. This is the same record the foundations station prescribed for special cases generally - recycled content is simply where the record earns its keep soonest.

Compostable plastic packaging sits outside the content targets because its end-of-life logic is biological rather than mechanical: a compostable format is designed to enter the organics stream, and requiring recycled plastic inside it would serve neither stream. The exclusion is narrow and should not be stretched by analogy - it covers packaging that is compostable in the regulation's sense, not any plastic a datasheet calls biodegradable. Formats claiming the exclusion carry the compostables station's evidence burden instead; relief in this regulation is always a change of duty, never an absence of it.