REACH regulation (EC) 1907/2006 consists of hundreds of pages, many annexes and extensive lists of chemical substances that are regularly updated.
The European Chemicals Agency (ECHA) responsible for managing the regulation on an European Union level has created thousands of pages of guidance to explain what needs to be done by the industry.
But what is really important, how does REACH affect your business? What is relevant for non-chemical, non-food consumer products?
REACH applies to all and only to chemical substances; not only those used in industrial processes but also in for example cleaning products, paints as well as in articles themselves such as clothes, furniture and electrical appliances.
The majority of requirements in REACH have to be applied to substances put on the market on their own or as part of a chemical mixture and are not relevant for an article or substances present in an article.
Any manufacturer or importer placing a substance on the EU market on its own or as part of a mixture at more than 1000 kg per year is required to do a registration under REACH before placing this substance on the markt. Registration of a substance involves submitting a vast and complicated technical dossier.
Substances in articles are exempt from the registration obligations, except if that substance in the article is intended to be release during normal and foreseeable use, like ink in a pen or fragrances from scented articles.
The regulation defines an article as:
“an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition”.
Or in other words, an article is generally understood to be an object composed of one or more substances or mixtures given a specific shape, surface or design, where the shape, surface and design is determining the function of the object.
These objects may be simple articles, like a paper sheet but can also be very complex, like a laptop computer, consisting of many articles. Most of the commonly used objects are articles, e.g. furniture, clothes, vehicles, books, toys, kitchen equipment and electronic equipment.
The requirements in REACH for substances in articles are limited to requirements stated in article 33 and the substance restrictions as listed in Annex XVII.
Important note: with the exemption of substances intended to be released which are also in scope of the registration obligations.
REACH Annex XVII contains restrictions on the marketing and use of hazardous substances. This Annex contains several requirements detailing specific restrictions of hazardous substances in different types of use, product or material.
The restrictions in this Annex always have a limited scope and application. For example the Annex restricts phthalates (DEHP, DBP and BBP) in plasticised materials used in toys and childcare articles or restricts the migration of nickel from metal materials coming into prolonged contact with the skin. If your product is not a toy or childcare article or does not have metal coming into prolonged contact with the skin, then these specific restrictions do not apply to your product.
In order to comply with the restrictions in Annex XVII it is important to know and understand if your product or materials fall in the scope of the restriction based on the intended and foreseeable use of the product.
Not all restrictions will be automatically applicable to your product.
Some substances have properties that are deemed to be of very high concern. These substances present particularly high risks to the human health and/or the environment and are added as “Substances of Very High Concern (SVHC)” to the so-called “Candidate list”.
This list is update twice a year by the ECHA in June and December. The addition of a substance to the candidate list triggers several legal obligations and actions:
Note 1: many retailers in the European Union consider the candidate list as a “restrictive” list and do not allow the presence of any SVHC above 0,1% in the products they are buying and selling.
In order to know what your obligations under REACH are and if you do comply with these obligation the following steps are recommended
Note: the registration obligations are triggered by the total additive volume of the substance per supplier, in other words, the volume of the substance needs to be added up if present in different products placed on the market by your company