Chemicals are an essential component of our daily lives, but some of them can severely damage our health and the environment.  There is an increase in health problems that can be partially explained by the use of chemicals since they are found in the most remote places in the environment but also in our bodies.

In order to take care of the environment and not endanger people and their environment, there are certain regulations that either limit the use of certain substances or directly ban them whenever there is no justification for their use.

Accordingly, anyone (manufacturer, importer or distributor) who wants to put an article into the European market will have to follow this set of regulations and standards in order to ensure its proper use and distribution.

In this article we will focus on explaining what REACH (Registration, Evaluation, Authorization and Restriction of Chemical Substances Regulation) and RoHS (Restriction of Hazardous Substances) regulations consist of, focusing on the process that an interested party must follow to comply with these regulations.

The main difference between RoHS and REACH is that first one bans substances that are present in electrical and electronic equipment in a quantity higher than a certain threshold. REACH, however, pertains to all chemicals including those used in the production of an article. This can include materials, solvents, paints, and other chemicals.

This regulation is managed by the European Chemicals Agency, which is in charge of the technical and administrative aspects of the regulations that we will describe in the following sections.

REACH, Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, entered into force on June 1st 2007 establishing procedures for collecting and assessing information on the properties and hazards of substances.

As mentioned earlier, in order to comply with this regulation, companies need to identify and manage the risks associated with the substances they manufacture and market in the EU. They must demonstrate to ECHA how the substance can be used safely and must communicate risk management measures to users.

The substances that are considered dangerous are defined as Substances of Very High Concern (SVHC). At ECHA, we can find 3 different types of lists according to the level of restriction that is imposed on the listed substances. These three lists are:

• The Authorisation list (Annex XIV)
• The Restricted list (Annex XVII)
• The Candidate list

REACH Directive SVHC lists structure

Annex XIV or “List of substances subject to authorization” includes the list of substances which may not be used, marketed for use or incorporated into an article, after the date (deadline for placing a substance in the market). indicated in this Annex, unless:

• • A use authorization is granted. Authorizations are granted for a limited time, although this time span can be extended after revision.

• • There is an exception or exemptions (provided in Article 56 of REACH or in Annex XIV) that allows the use of a substance for a particular use. For instance, the uses in medical devices within the scope of Directives 90/385/EEC, 93/42/EEC and 98/79/EC until 27 May 2025 or for uses in mixtures containing DIBP at or above 0.1 % until 14 Dec 2024.

It is important to note that authorizations are granted for specific uses to the company that has requested the authorization. However, article 56 (2) contemplates the possibility for downstream users to use a substance for which authorization has been granted to their supplier, provided that they make use of the substance in accordance with the conditions of the authorization granted to their supplier. When an authorisation is given to a substance for a particular use, an authorisation number is generated. This number shall appear in the label of the relevant substance or mixture.

All these substances identified as SVHC are included in Candidate List and ECHA recommends including substances from this list in Annex XIV every 2 years. The SVHC are identified according to article 57 of REACH:

• • Substances classified as carcinogenic, mutagenic or toxic for reproduction in categories 1A or 1B.
• • Substances considered persistent, bioaccumulative or toxic (PBT) or very persistent and very bioaccumulative (vPvB).
• • Substances of equivalent risk to human health or the environment (e.g. endocrine disruptors).

Annex XVII contains the “restrictions on the manufacture, marketing and use of certain substances, mixtures and articles, that is, we can make use of these substances as long as the use we want is not restricted.

This one is not based on substances included in the Candidate List (SVHC), although the same substance could be included or proposed for inclusion in the Candidate List and also in Annex XVII. This annex includes substances with any type of risk.

In turn, we must take into account certain regulations regarding Annex XIV and XVII:

• • SVHC in Annex XIV may not also be subject to new restrictions for the risks to human health or the environment by the use of a substance as such, in the form of a mixture or in an article, due to the intrinsic properties by which the substance has included in Annex XIV, that is, there cannot be a restriction and an authorisation for the same substance use.

• • New restrictions may be imposed for the risks of the substance on human health or the environment, when the substance is present in an article, if it is considered that these risks are not adequately controlled.

• • When Annex XVII completely prohibits the use / uses of a substance, it will not be included in Annex XIV.

• • When a substance for which an authorization for use has been granted is also included in Annex XVII, must meet both the conditions of the authorization granted and the requirements of the restriction must be met.

Compliance diagram for REACH Directive

In short, in order to be able to put an article into the European market and verify that we comply with the REACH regulations, we must carry out the following process:

1. We need to identify all the substances that our articles contain.

2. Next, we must check the lists mentioned above and see how our substances are catalogued.

3. Once all the SVHC have been identified, we must see the use that we are giving them and verify that we are outside the restricted uses.

4. In the case of having a substance in Annex XIV, we must verify that we have the required authorization, apply for it or we can add to a prior one.

5. We will constantly check these lists for any update.

The Restriction of Hazardous Substances Directive (RoHS), also known as Directive 2002/95/EC, entered into effect on July 1, 2006. The RoHS 2 directive (2011/65/EU) is an evolution of the original directive and became law on 21 July 2011 and took effect on 2 January 2013. It addresses the same substances as the original directive while improving regulatory conditions and legal clarity. A further RoHS amendment (2015/863) followed in 2015, adding four more substances to the list of restricted chemicals under Annex II. As of July 22, 2019, these substances cannot be placed on the EU market in concentrations above 0.1 percent, weight by weight (w/w).

Therefore, as said before, any company that sells electrical or electronic products, equipment, sub-assemblies, cables, components or spare parts directly to countries binded by RoHS, or sells them to resellers, distributors or integrators who in turn sell products to them must comply with this regulation.

In comparison to REACH, the quantity of substances which are affected by the RoHS regulation is considerably reduced.

EU RoHS does not ban any substance, but specifies, in Annex II, maximum levels for the 10 restricted substances:

It is worth mentioning, that there are certain applications which are exempted from the restrictions (listed in Annex III and IV). Many of the exemptions are currently expired, but some of them are still applicable, such as the use of Lead as an alloying element in steel for machining purposes for Monitoring and control instruments including industrial monitoring and control instruments (up to 0.35% Lead by weight).

Compliance diagram for RoHS Directive

But generally, as long as the concentration of all hazardous substances in our electronic items are below the established limit, we will be compliant with this regulation.

When a product is compliant with RoHS, the EEE manufacturer has to produce an EU declaration of conformity (in line with the format proposed in the Directive) which indicates that it has been demonstrated that the RoHS requirements are fulfilled. By drawing up the EU declaration of conformity, it is the manufacturer who takes responsibility for the conformity of EEE with this Directive. And, of course, this declaration has to be forwarded to the downstream users of the articles.

Also, once the declaration of compliance is obtained, the articles have to incorporate the CE marking. This will be placed visibly, legibly and indelibly on the finished EEE or on its nameplate.

In this article we have seen the two most important chemical regulations of the European framework, each of which has been detailed separately highlighting the procedure to verify that our articles comply with these regulations and, consequently, to be able to use them. We have looked at the different criteria for identifying whether a substance is considered in the directive and how it is classified. We’ve seen different exemptions depending on how we will use the substance, and finally we’ve seen some highlights from each of the regulations.

In short, we can finish this article, knowing the importance of the selection and control of materials in order to ensure the well-being of all and to comply with regulations and future updates.