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REACH Compliance for Dry Bags

What REACH is and who actually carries the obligation

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals, and it is administered by the European Chemicals Agency in Helsinki with enforcement handled by national authorities in each member state. Registration applies to substances manufactured or imported above one tonne per year. Articles, which is what a finished bag is, are not registered, but they are still caught by the restriction and communication provisions, and by the notification duty when they contain a listed substance above the threshold.

The obligation sits with the party placing the article on the EU market. If a brand imports bags into the EU, the brand is the importer and carries the duty; if a distributor inside the EU buys from outside and imports, the distributor carries it. A production partner outside the EU cannot hold the legal duty, which is why a well-run programme treats compliance documentation as a deliverable of the order rather than a favour. Get that written into the brief at the start, because retro-fitting a chemical test programme after a shipment has landed is expensive and slow.

Articles, substances and mixtures: where a dry bag sits

REACH splits the world into substances, mixtures and articles, and the classification decides which duties apply. A substance is a single chemical. A mixture is a blend, such as an ink or an adhesive. An article is an object given a special shape, surface or design whose function depends more on that shape than on its chemistry, and a dry bag is unambiguously an article. Its component materials are still assessed individually, because a restriction applies to the substance in the material regardless of what the material became.

One extra duty applies only to articles with intentional release. A bag that releases a fragrance, an antimicrobial agent or a biocidal finish as part of its function moves into a different regime, where registration and authorisation can apply to the released substance. A bag that merely contains a chemical does not. If you are specifying an antimicrobial lining or a scented finish, flag it early, because it changes the paperwork more than any other single decision in the specification.

The candidate list and the 0.1 percent threshold

The candidate list of substances of very high concern is the heart of the system. It contains substances that are carcinogenic, mutagenic or reprotoxic, persistent and bioaccumulative, or of equivalent concern, and it has grown past 240 entries with updates roughly twice a year. If an article contains any listed substance above 0.1 percent by weight, the party placing it on the market must be able to communicate that to the next link in the chain, and to answer a consumer request within 45 days free of charge.

Two features of the threshold catch people out. It is calculated on the whole article, not on the material containing the substance, so a small plasticised logo patch on a large bag is diluted by the mass of the bag and may fall below the limit. And the list changes: a declaration verified against a candidate list version from two years ago is out of date the moment a new substance is added. Ask for the declaration to name the version, and re-verify at least annually or whenever the list is updated.

Above one tonne per year of a listed substance across all articles from the same producer or importer, a notification to the agency is required, and since January 2021 the same trigger creates a SCIP database submission under the Waste Framework Directive. Most bag programmes never reach the tonnage, but the communication duty applies regardless of volume, so the screening is worth doing even for a small shipment. Our chemical migration testing notes explain how screening differs from migration testing.

Annex XVII restrictions that actually hit bags

Annex XVII is the restriction list, and it is where the hard numbers live. Unlike the candidate list, a restriction is not a disclosure duty; it is a prohibition above a stated limit, and a bag over the limit cannot be placed on the EU market at all. The entries that matter for waterproof bags are the phthalates restriction, the azo dye entry, the polycyclic aromatic hydrocarbon entry, the nickel release entry and the perfluorinated entry, with chromium VI and dimethyl fumarate appearing when leather or anti-mould treatments are involved.

Each entry has a scope, and scope is where most arguments are won. The phthalate limit applies to plasticised material in the article, so a rigid plastic buckle is assessed differently from a soft PVC coating. The azo entry applies to textile and leather that comes into direct and prolonged contact with human skin, which catches a backpack harness and not the outer shell of a bag you carry by a handle. Reading the scope first saves a lot of unnecessary testing.

Phthalates: the reason TPU replaced PVC in most programmes

Phthalates are plasticisers added to polyvinyl chloride to make it flexible, and four of them, DEHP, DBP, BBP and DIBP, are restricted to 0.1 percent by weight of the plasticised material. That limit is far below the level needed to soften PVC, so a genuinely flexible PVC-coated fabric cannot be made compliant with the restricted phthalates. The industry response was to move to alternative plasticisers for some applications and to thermoplastic polyurethane for most others.

TPU is intrinsically flexible and needs no plasticiser at all, which removes the phthalate question from the film entirely rather than lowering it below a threshold. That is the single strongest compliance reason to specify TPU over PVC on a bag that will be sold into the EU, and it comes with the processing and cold-weather advantages as well. If a programme must use PVC for cost reasons, demand a phthalate test report on every fabric lot rather than on a single sample; our phthalate-free notes and PVC-free alternatives cover the trade-offs.

Azo dyes, amines and the printed or dyed parts

Azo dyes are the largest family of colourants used on textiles, and a subset of them can break down under reducing conditions to release aromatic amines that are classified as carcinogenic. The restriction lists 22 amines at a limit of 30 milligrams per kilogram of finished textile or leather, tested by reduction followed by gas chromatography and mass spectrometry. Dark, saturated shades and cheap disperse dyes carry the highest risk, which is why black webbing and printed panels deserve more attention than the shell.

The scope test is direct and prolonged skin contact, so a harness, a shoulder strap, a hip belt and a back panel are in scope while an outer shell is generally not. Because the scope argument is easy to get wrong and the test is inexpensive, most serious programmes simply test every dyed textile component rather than arguing the scope each time. Ask the mill for a dye-house declaration as well as a test report, and re-test whenever a colourway changes, because a new shade may use a completely different dye formulation.

PFAS, water-repellent finishes and the moving target

Per- and polyfluoroalkyl substances give a fabric oil and water repellency, and for years they were the standard answer to a durable water-repellent finish. Perfluorooctanoic acid is restricted under Annex XVII, and the longer-chain chemistry has been withdrawn from the market almost everywhere, but the regulatory direction is now a broad restriction covering the whole family rather than individual substances. A universal PFAS restriction proposal covering all uses has been under development in the EU for several years, with derogations for specific essential uses.

The practical consequence is that a durable water-repellent finish on a dry bag should be specified as PFAS-free today, whether or not the restriction has landed. A welded TPU bag does not need a repellent finish at all, because the film carries the waterproofing and the face fabric only needs to shed water quickly enough not to stay soaked. Ask for a declaration of total fluorine rather than a statement that the finish is PFOA-free, since a total fluorine screening test is the only way to detect a replacement chemistry our PFAS-free guide describes the alternatives and their limits.

Metals in hardware: nickel, lead, cadmium and coatings

Metal components are the second highest risk area after coatings. The nickel restriction applies to articles in direct and prolonged contact with the skin and is expressed as a release rate rather than a content limit: 0.2 micrograms per square centimetre per week, measured by EN 1811 in artificial sweat. Content limits for lead and cadmium come from other instruments, with 100 parts per million for lead in children products under the United States rule and lower thresholds in some member states, so a programme selling on both sides of the Atlantic usually specifies to the stricter figure.

Coating is the variable that decides the result. An uncoated zamac buckle will usually fail a nickel release test within a season once the plating wears; the same buckle with a sealed electrophoretic or powder coating passes comfortably. Salt water accelerates the wear, so a bag sold for paddle sports should be specified with coated hardware as a matter of course. Our hardware compliance notes and the corrosion resistance guide take this further.

Testing: what to send, to which laboratory, and how often

Test the material, not the finished bag. A laboratory needs a flat sample of each distinct material: the laminated shell, the lining, the webbing, each colourway of print, the film, the coating on the hardware, the zip tape and the puller. Send 20 to 30 square centimetres of each, labelled with the material name and the colour, and include a bill of materials so the laboratory can tell you which restrictions apply to which component. A single composite test on a cut-up bag is cheaper and much less useful.

Use a laboratory accredited to ISO/IEC 17025 for the specific methods you need, because a report from an unaccredited laboratory will not be accepted by an enforcement authority or by a large retail buyer. Turnaround is typically five to ten working days for a standard panel, longer for a full candidate list screen. Budget per material rather than per bag: phthalate screening is modest, azo screening similar, a nickel release test takes a week of incubation, and a broad SVHC screen is the most expensive single item.

Documentation: declarations, SCIP and the technical file

Four documents make up a defensible file. A restricted substance list declaration from each material producer, naming the regulation and the candidate list version it was checked against. Test reports from an accredited laboratory, dated within the last 12 months, for every material and every colourway. A finished-article declaration from the producer, stating that the bag as assembled meets the restrictions. And a technical file that ties the bill of materials to the reports, so a question about one buckle can be answered in minutes.

The SCIP database submission applies when an article contains a candidate list substance above 0.1 percent, and it is a notification to the agency rather than a document sent to a buyer. Most compliant bag programmes produce no SCIP entry at all because nothing is above the threshold, which is worth stating explicitly in the file: a negative result recorded is far better than a silence that has to be investigated later. Keep the whole file for at least ten years after the last shipment, because that is how long an enforcement question can arrive.

REACH beyond the EU: UK, California and the voluntary schemes

The United Kingdom has operated its own UK REACH since leaving the European system, administered by the Health and Safety Executive with its own transitional deadlines. The substance lists largely mirror the EU lists at the point of separation and diverge slowly, so a programme selling into both markets needs the declaration to name which regulation it was assessed against. Northern Ireland follows EU REACH for goods placed on its market, which adds a third case to an already long list.

California Proposition 65 is a different instrument with a different mechanism: it is a warning obligation rather than a prohibition, driven by a list of substances and by private enforcement, and it applies to products sold into that state. Voluntary schemes sit alongside both. OEKO-TEX Standard 100 is the most widely used textile label and covers many of the same substances with its own limits; bluesign adds input-stream control across the dyeing and finishing chain. Neither replaces REACH, and both are useful evidence that a supply chain is being managed rather than merely tested. Our OEKO-TEX notes and Proposition 65 guidance cover them separately, and marine-safe material notes address the ecological side of the same question.

Writing a restricted substance list into a brief

• Name the regulation and the version: REACH Annex XVII, plus the candidate list version the check was made against.
• List every material on the bill of materials, including hardware, ink, webbing, thread and any sachet in the packaging.
• State the limit for each substance rather than writing compliant or safe, so the requirement can be tested.
• Require ISO 17025 accredited reports, dated within 12 months, for each material and each colourway.
• Specify TPU rather than plasticised PVC wherever the programme can bear it, and say why.
• Require coated hardware on any component in skin contact, and name EN 1811 as the method.
• State who pays for re-testing when a material changes, and what happens to a lot that fails.

Two clauses do more work than the rest. The first requires the producer to notify you before any material substitution, because a silent change of webbing source is the most common way a compliant programme stops being compliant. The second makes the test reports a condition of release rather than a document to be sent later, so a lot that cannot produce a report does not ship. Both are cheap to write and impossible to retro-fit after a container has sailed.

A thirty-day compliance plan for a bag programme

1. Day 1 to 3: build the bill of materials, listing every component, material, colour and coating separately.
2. Day 3 to 5: send the restricted substance list to every material source and ask for a declaration naming the candidate list version.
3. Day 5 to 8: collect material samples, labelled, and send them to an ISO 17025 accredited laboratory.
4. Day 8 to 18: run the panel: phthalates, azo amines, nickel release, PAHs where rubber is used, and total fluorine.
5. Day 18 to 22: review reports against the limits, and re-test or substitute anything that fails or sits near a limit.
6. Day 22 to 26: assemble the technical file, linking each report to a line on the bill of materials.
7. Day 26 to 30: issue the finished article declaration, set a re-test calendar, and record who owns each document.

The re-test calendar is what makes the plan durable. Set annual re-testing for stable materials, immediate re-testing on any material or colour change, and a candidate list review every six months to match the publication cycle. Assign the file to a named person rather than to a department, because the most common failure in an enforcement action is not a failed test but an inability to find the document that proves a passed one.

Our own waterproof line has run since 2014 in an SGS-verified 4,950 m2 facility with seven production lines, and restricted substance documentation is issued with sampling rather than after bulk, because a test that arrives late is a test that only produces bad news.Restriction and test texts are published by the European Chemicals Agency, laboratory accreditation standards by ISO, metal release methods by ASTM and broader chemical inventories by the EPA, so every figure in a brief can be checked against a published source. Compare the material set on our eco-friendly dry bag range before you specify the next one, and keep the frequently asked questions page handy for the questions a retail buyer will ask first.