Stress free guide to product compliance

2021-02-19
ProductIP
Intermediate

EU regulation 1907/2006 - REACH

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

Registration, Evaluation, Authorisation and restriction of CHemicals (REACH) - how does this apply to your non-food consumer product?

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?

Principle of REACH

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.

Main obligations under REACH

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.

What is considered an article under REACH?

The regulation defines an article as:
“a
n 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.

What are the article requirements?

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.

Annex XVII restrictions

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.

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Article 33: Substances of Very High Concern

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:

  • Suppliers of articles which contain a SVHC listed on the candidate list in a concentration above 0,1% (weight by weight) have to communicate the presence of this SVHC to their downstream user and provide enough information to allow the safe use of the article, with as a minimum the name of the SVHC. The communication needs to directed to any industrial or professional users and distributors [including retailers], but not to consumers.
  • However, consumers can request for information on the presence of SVHCs. You are obliged to provide this information within 45 days, free of charge.

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.

Note 2: certain countries like Germany, Sweden and Denmark actively promote consumers to ask SVHC questions to retailers.

  • Within 6 months after the SVHC has been included manufacturers and importers have to notify to ECHA if the SVHC is present in their articles above a concentration of 0,1% weight by weight and the SVHC as part of the article is placed on the market in quantities totalling over one tonne per year per supplier.
  • After inclusion on the candidate list a SVHC might be added by the ECHA to Annex XIV - “list of substances subject to authorisation” - of REACH requiring prior authorization before being allowed to be used in the European Union. Potentially leading to a SVHC to be no longer available on the European market.

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What to do to ensure compliance with REACH?

In order to know what your obligations under REACH are and if you do comply with these obligation the following steps are recommended

  • Make sure that you know if you are placing "substances" on the European market for the first time in more than 1000 kg per year, such as substances as part of chemical mixtures like household cleaners, clay or paint; important this also includes substances that are intended to be released from articles like ink in a pen.

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

  • Make sure you are aware of the relevant REACH Annex XVII restrictions for your product and ensure that if your product, article or material is covered in the scope of a restriction it complies with this restriction.
  • Make sure you are aware of any SVHC present above 0,1% in the materials used for your product. If a SVHC is present above 0,1%, ensure you monitor the total volume. Placing on the market of more 1000 kg per year of the SVHC as part of an article triggers a notification obligation to the ECHA.
  • if you are using chemicals in your production facility, office or warehouse in the European Union, make sure you follow the advice for safe handling, use and disposal as given by your supplier. This information, as available in the Safety Data Sheet, must be followed.

More information

For more information on REACH and additional guidance please have a look at the website of the ECHA or your national REACH Helpdesk.

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