Which regulations do I need to follow?

Companies have full responsibility for how the chemicals they produce or use affect people and the environment.  There are a number of different regulations companies must follow in order to protect and prevent chemicals from impacting human health and the environment.

REACH

REACH is the European Community Regulation on chemicals and their safe use. It deals with the Registration, Evaluation, Authorization and Restriction of Chemical substances. The law entered into force on 1 June 2007.

What is REACH?

REACH is the EU’s chemicals regulation, which is based on the idea that Manufacturers, importers and downstream users should guarantee that the substances they manufacture, release to the market or use are safe for both people and the environment. The regulation requires registration of chemical substances manufactured or sold as chemical substances, products, or used in articles.

REACH creates a number of new responsibilities for companies who manufacture, sell or use chemicals. It is therefore important that you understand the roll your company has and how the corresponding responsibilities may affect your business.

Why was REACH needed?

The goal of REACH is to improve understanding and knowledge of the chemicals sold in Europe, which European citizens are being exposed to daily, both at work and at home. There are currently about 100,000 substances being sold to the European market, yet for only a few of these substances have toxicological, physical and ecotoxicological properties been determined. The responsibility to guarantee that a chemical is safe to use has now been laid upon the chemicals industry. REACH is designed to protect the health of people and the environment while also improving competition and innovation within the European chemicals industry.

What does REACH mean for your business?

Businesses which manufacture, import, distribute or use chemical substances or mixtures are affected by REACH. It also will affect businesses which manufacture, import or distribute articles. There is a large difference in responsibilities depending on which roll you have under REACH and your position in the supply chain. It is important that you therefore understand which roll/ rolls you have according to REACH.  Do you manufacture substances?  Do you import articles from Asia?

REACH covers many different branches

Almost all products available on the market contain chemical substances. Therefore businesses in all different branches have legal responsibilities under REACH. Even businesses which ”only” distribute or use chemicals are included in the REACH regulation.

Some products are still exempt from REACH, such as pharmaceutical, food and cosmetic products. In such cases other regulations have precedent.

Examples of business which must follow REACH

In all of the below examples, it is assumed that a chemical substance is imported to or manufactured in Europe in amounts exceeding 1 tonne per year. It is important to know that your business may have multiple rolls in relation to REACH.

  • A company which manufactures a substance for inclusion in detergents, coatings or glue.
  • A business which uses chemicals at a building site, in a car garage, or at a hair salon.
  • A company which formulates paints, but is not importing or producing the chemical substances used.
  • An importer or distributor of glue, lubricants, detergents, toys, electronics or coatings from a land outside of the EU.
  • A business which imports of mechanical parts from China and uses chemicals for maintenance of the machines.
  • An electronics Manufacturer who imports specific chemicals for the production process.

Registration

In order to manufacture or sell a chemical substance within the EU, the substance must first be registered with ECHA, the European Chemicals Agency. Companies producing a chemical in excess of 1 tonne/year are required to register the chemical. This also includes the registration of substances which are included in a mixture. Manufacturers and importers of articles are also required to register , if the article is designed to release the chemical substance. A scented eraser is an example of an article which is intended to release a chemical substance.

Registrations are done electronically through ECHA’s REACH-IT portal. There is a fee for registration of a substance with ECHA, according to the Commission Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency in connection to REACH registration. Read more about REACH registration.

REACH registration is to be done over a number of years according to a set schedule linked to the amount release to the market and the hazards associated with the chemical. The most hazardous substances and those manufactured in very large amounts were registered first.

ECHA’s inventory of registered substances

ECHA regularly publishes on their website the information and data on chemical properties and toxicity which has been gathered as a result of substance registration.

Fines – what happens if you don’t register?

Willful or negligent violation of the requirement to register a chemical substance is punishable by a fine or imprisonment not exceeding two years (Chapter 29. 3 b §  of the Environmental Code). If the offense is deemed serious, the punishment can be imprisonment for between six months and six years.

Substance Information Exchange Forum – substance registration consortium

Companies that intend to register the same phase-in substance should join a Substance Information Exchange Forum (SIEF) to share data on the intrinsic properties of the substance and to avoid the duplication of studies. In particular, they have the obligation to share all test data on vertebrate animals. The members of the SIEF should also agree, if possible, on the classification and labelling of the substance.

Information in the supply chain – you may have obligations

Chemical suppliers must inform their customers regarding a chemical’s hazardous properties, risks and which protective measures may be needed. Such information should be communicated via the safety data sheet (SDS) and exposure scenario. Articles containing substances of very high concern also require such information. Safety Data Sheets should be updated when there is new information about the risks and dangers.

The Candidate List – your responsibility to inform?

Does your company manufacture, import or sell articles? If so, you are liable to inform your customers and consumers if your products contain substances of very high concern, which are those substances included in the Candidate List (REACH Article 59).

When an article contains more than 0.1 wt% of a substance on the Candidate List, REACH requires the supplier of the article to inform customers using the article for their work.   Private consumers who request information regarding Candidate List substances in articles must also be provided with the information within 45 days of their request. Clothes, electronics, tools, computers and toys are examples of articles.

Dangerous chemical substances in articles is a growing problem. New substances are suggested for addition to the Candidate list continuously, and new substances are added twice per year. These substances are then candidates for inclusion in Annex XIV of REACH, which is a list of substances which require Authorization for continued use within the EU in articles or chemical products.

Do you manufacture, import or sell articles?

Article 3.3 in the REACH 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 does its chemical composition.

To determine if something is an article, you should therefore determine whether the form determines the function.  If the form is critical to the function, then it is likely an article.  Items which have a critical shape, such as a cup or a plastic chair, are articles. Paints, cleaning products, candles and cosmetics, however, are not articles under REACH. They are chemical mixtures.

Which substances are on the Candidate List?

The Candidate List is an EU list of chemicals which are especially hazardous. They are often called SVHC substances (Substances of Very High Concern). These type of chemicals have long-term effects on human health or the environment.

The information requirement in REACH means that there must be an efficient flow of information through the supply chain from Manufacturers or importers of articles all the way down to the end user (e.g. to you as a consumer). It is important that all purchasing agents be sure that they get the information they need as they receive an article.

Checklist for purchasing agents and/or suppliers

  • Check for Candidate list substances in your articles which then require downstream communication.
  • Ask your suppliers if there are Candidate List substances in the articles you buy – if so, what wt% concentration?
  • Determine if there is a requirement to inform recipients of the article regarding safe handling.
  • Design an internal system to make sure you can communicate the required information on Candidate List substances in your articles to your customers.
  • Check regularly for new substances in the Candidate List.  Downstream communication is required from the day a substance is added to the list.  A good way to do this is to subscribe to ECHA’s newsletter so you know what substances on being considered for inclusion.

If you import articles from a land outside the EU it may be much more difficult to get information from your suppliers than if you import from a land within the EU.

Here is a link to the Candidate List.

Authorization – important to know if you use substances or mixtures which require authorization

When a substance has been included in Annex XIV of REACH, it means that that substance may not be used or put on the market without authorization from the European Chemicals Agency, ECHA. In Annex XIV a “Sunset date” is given, past which a substance may no longer be used without authorization. Requests for authorization must be submitted to ECHA before the “Latest Authorization Date.”

Here is a link to the Authorization List

Prohibitions and Limitations

REACH Annex XVII contains substances which are completely or partially forbidden for use in chemical products or articles. Many of the substances have had limitations or been forbidden previously under individual Directives.

Your roll and responsibilities under REACH

Many more companies are liable under REACH than have been liable under earlier chemical regulations. In order to determine the responsibilities you have under REACH you must know which roll you have. It is important to note that a company may have many different rolls, in that a company may be both a Manufacturer and user of chemical substances.

Manufacturers and Importers

A manufacturer is any natural or legal person established within the European Community who manufactures a substance within the Community; (Article 3.9). The definition of a manufacturer in Reach does not include companies which only manufacture mixtures.  A manufacturer of mixtures is defined as a downstream user, and in some situations as an importer.

An importer is any natural or legal person established within the Community who is responsible for the physical import of a substanceor to the EU customs territory (Article 3.11).

Under REACH manufacturers and importers are required to:

  • Register the substances they manufacture or import.
  • Prepare and distribute safety data sheets or other information to their downstream users.
  • Make sure the information in the safety data sheets and other information to downstream users is updated.
  • Check whether the substance requires authorization and, if the manufacturer or importer wants to continue to use the substance or set it on the market after the “sunset date”, request authorization.
  • Register the substance in the classification and labeling inventory.

For substances or mixtures classified as hazardous, or substances with other certain properties, a safety data sheet must be supplied by the first delivery. Under certain conditions mixtures not classified as hazardous an SDS must be provided if the recipient requests it.

The supplier of a substance or mixture is responsible to make sure the information provided to downstream users is updated (Article 31.9 and 32.3).

Downstream Users

A downstream user is any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities.

A distributor or a consumer is not a downstream user. Below are some examples of downstream users:

  • Formulator– one who uses a substance to manufacture a mixture, such as a detergent or a paint, which then is sold either to professional users or private consumers.
  • A company which uses a substance or mixture to produce an article – for example one who added a stabilizing agent to plastic
  • Industrial user – one who uses a substance in a production process, such as a degreasing agent prior to a surface treatment
  • Professional user – one who uses a substance or mixture in their business, for example a service provider (a cleaning company which uses detergent formulations) or an artisan (a painter who uses paints for their work)

A downstream user is required to:

  • Provide the safety data sheet or other relevant information to downstream users of the substance or mixture, or an article containing certain substances
  • Make sure the safety data sheet and other relevant information provided is updated and current
  • Make sure that – when required – the safety data sheet is delivered to downstream users no later than the first delivery.  Mixtures not classified as dangerous may in certain cases also require safety data sheets upon request of the downstream user.
  • Forward new information about hazardous properties and appropriate risk management measures up the supply chain
  • implement the recommended risk measures described in the safety data sheet or in their own CSR

Distributor / Reseller

A distributor is any natural or legal person established within the Community, including a retailer who only stores and places on the market a substance, on its own or in a preparation, for third parties.  (Article 3.14)  A distributor is not a downstream user but is instead considered to be a supplier according to REACH.

Some of Distributor’s responsibilities include:

  • Provide a safety data sheet or other relevant information to the users of substances or mixtures which contain certain substances.
  • Make sure safety data sheets and other relevant information for users is updated.
  • Forward new information regarding hazardous properties and appropriate risk management measures upwards to the next actor or distributor in the supply chain.

Relation between REACH and CLP

Rules on classification and labeling are a necessary tool in REACH. The correct classification of a substance is a tool for describing the dangers and risks a substance may have in relation to human health and the environment. REACH expands the risk assessment.