REACH

Definition and Purpose of REACH

REACH is the abbreviation for Registration, Evaluation and Authorisation of Chemicals. What is meant is the EU Chemicals Regulation (EC) No. 1907/2006. It defines how chemical substances may be manufactured, imported, used, and placed on the market in the EU. The core purpose is a high level of protection for humans and the environment.

REACH also requires transparency along the supply chain. Companies should know which hazardous substances are contained in materials, preliminary products, and components. In plastics and sealing technology, REACH therefore becomes relevant as soon as certain substances are restricted — particularly under Annex XVII — or when SVHCs (substances of very high concern) appear in articles.

Scope: Substances, Mixtures, and Articles (What Is an “Article”?)

REACH distinguishes three levels that often occur simultaneously in technical supply chains. A substance is a single chemical. A mixture is a blend of substances — for example an adhesive, an oil, or a cleaning agent. An article is an object whose function is primarily determined by shape, surface, or design and not by its chemical composition.

For sealing technology, this distinction is central. An O-ring, a profile seal, or a molded seal is usually an article. Obligations then frequently arise via the question of whether candidate-list substances are contained in relevant concentrations. Mixtures tend to be in focus where seals are processed — for example with assembly aids or coatings.

REACH Roles Along the Supply Chain and Typical Obligations

Which obligation specifically applies depends on who you are in the market. Manufacturer, importer, downstream user, and supplier have different responsibilities. In sealing technology, importers and suppliers of articles are particularly frequently affected, because they trigger or pass on information obligations toward the customer.

SVHC, Candidate List, and Obligations at $>0.1\%(w/w)$

SVHC means substances of very high concern. These include, among others, CMR substances (carcinogenic, mutagenic, toxic to reproduction) as well as PBT/vPvB substances (very persistent and bioaccumulative). Decisive is when a substance enters the obligation logic: the trigger is its inclusion in the ECHA candidate list.

For articles, a central threshold applies: $>0.1\%(w/w)$, that is, more than 0.1 mass percent of the SVHC in the article. If this threshold is exceeded, Article 33 applies: suppliers must give commercial customers information that enables safe use. In practice, this includes at least the substance name and meaningful handling guidance.

In addition, Article 7(2) can become relevant. Then a notification to the ECHA is required when the SVHC is both contained in the article at $>0.1\%(w/w)$ and occurs in the affected articles at a total of $>1\text{ tonne/year}$ per manufacturer or importer. As a result, a pure information obligation becomes a formal notification obligation.

Documents and Data Exchange in the Supply Chain

In everyday practice, REACH conformity is rarely decided “by the material name”. It is supported via data showing which substances occur in which fraction and which lists have been checked. Therefore, written declarations and material data are frequently exchanged in sealing projects.

• SVHC declaration, referenced to the candidate list, usually with date/version
• Material or substance data for recipe transparency at an appropriate level
• Safety data sheet (SDS), particularly for mixtures such as adhesives or assembly aids

SCIP Notification as a Coupled Additional Requirement

In the REACH environment, SCIP frequently appears. SCIP stands for Substances of Concern In articles as such or in complex objects and originates from EU waste law. For companies, however, it acts like a direct extension of REACH, because the trigger is similar: SVHCs from the candidate list at $>0.1\%$ in articles placed on the EU market.

SCIP is strongly data-driven. It typically requires information on the component structure (article in complex objects) and on the allocation of the SVHC. In sealing technology supply chains, SCIP capability is therefore frequently requested early — for example when seals are delivered as part of larger assemblies.

Authorisation (Annex XIV) vs. Restriction (Annex XVII), and Typical Relevance for Sealing Materials

REACH uses two particularly effective instruments that have different consequences in technical applications. Authorisation appears in Annex XIV: for certain particularly critical SVHCs, use after a deadline (sunset date) is permitted only when an authorisation has been granted for the specific use. This is particularly relevant when a substance is intentionally used in processes or recipes.

Restrictions appear in Annex XVII. They define whether a substance may not be used at all or only under limit values and for certain applications, or whether it may be placed on the market. For seals, this is frequently the more immediate lever, because restrictions can affect typical application areas.

In sealing technology, materials are rarely “one substance”. Elastomers and engineering plastics consist of a polymer matrix plus additives such as plasticizers, fillers, processing aids, or vulcanization chemicals. REACH, however, assesses chemicals, not trade names of materials. Therefore, in practice, assessment runs via substance lists, supplier declarations, and material data. At a high level, substance groups that can occur in recipes are relevant — for example certain plasticizers or certain fluorinated chemicals.

A reliable REACH assessment usually succeeds when it is clear early on which role a company takes, whether a product is considered an article or a mixture, and which candidate-list substances are actually contained. With complex supply chains, specialized regulatory consultation can be sensible.