REACH Regulation

What is the REACH regulation?

REACH is the European regulation for the Registration, Evaluation, Authorisation and Restriction of CHemicals substances (EC) No 1907/2006 entered into force on 1 June 1997. It is the main European regulation concerning chemical products and controlling the risks involved in their use. It refers to chemicals, covering in principle all substances on their own or in mixtures or in articles (such as lightsticks) for industrial, professional or consumer use. Therefore, REACH has an impact on most industrial sectors and applies to most companies in the EU, including companies who might consider themselves not be concerned by chemical substances.

The main purpose of REACH is the sustainable protection of the health of the people and the environment, by requiring the identification of the intrinsic properties of chemical substances. To comply with these requirements, professionals must declare and register with the European Chemicals Agency (ECHA) any substance produced or imported in a quantity of more than one ton per annum.

Is it an offence if I fail to comply with REACH?

Failure to comply with the obligation to register

If the obligation to register a chemical substance as stated by REACH is not complied with, it will be considered as an offence. The Community penalties can take the form of prohibition on manufacture, import, place on the market, use a non-registered or non-authorized substance. Furthermore, each EU Member State also determines the penalties applicable in the event of infringements.

There are two types of penalties that are independent of one another: the criminal penalties and the administrative penalties. They can be imposed simultaneously. The penalty can also come from economic actors with each other since only substances, mixtures or articles in compliance with REACH regulation can be placed on the market.

Administrative penalties

In France for instance, there are different types of supervisory authorities (DRIRE, DREAL, Labour Inspectorate, DGCCRF, DGDDI (Customs)…) and they have a wide range of control of competencies. In case of failure to meet REACH obligations, or the rules regarding classification, labelling and packaging (CLP) from a manufacturer, an importer or a user, any of them may be given notice.
If the formal notice is ignored, different types of penalties do exist:

  • Fine ≤ 15 000€/ daily penalty of 1 500€
  • Deposit of sums to constrain
  • Prohibition against importation, manufacture or place on market
  • Re-export outside EU or disposal supported by the manufacturer or the importer
  • Offence in case of failure of formal notice

Penal sanctions

The penal sanctions are prescribed for most serious offences.

2 years imprisonment and fine of 75 000€ in case of:

  • Registration/authorization default
  • Non-compliance with the prohibition/restrictions measures
  • Non-compliance with a formal notice
  • Manufacture or import of a substance or a mixture without preliminary registration and use of fraudulent means to obtain a registration number
  • Supply of incorrect information / withholding of information on substances
  • Place on market without prior classification / without labelling and packaging of substances and/or dangerous mixtures

6 months imprisonment and fine of 7 500€ in case of:

  • Obstacle to control officers

3 months imprisonment and fine of 20 000€ in case of:

  • Non-compliance with obligations regarding SDS transmission and management to recipient of chemical products
  • Failure to notify ECHA with classification and labelling

Many contraventions on the following cases:

  • Not write CSR (Chemical Safety Report) (downstream user)
  • Duplicate studies requiring tests on animals despite previous existing surveys
  • Refusal to communicate information on substances and mixtures from any player in the supply chain

Supplementary penalties applicable to natural persons

  • Temporary or permanent closure of installation concerned
  • Confiscation of the substance
  • Prohibition of exercise of activity

When will REACH come into effect?

REACH has been in effect for some time now.  However REACH regulation planned three deadlines to register substances that have been pre-registered. The 31st of May 2018 is the last deadline to register with this European Regulation REACH.
In other words, since the 31st of May 2018 according to REACH regulation, “No Data, No Market”: without any information on chemicals used, they are formally prohibited to be placed on the market.
ECHA establishes restricted and specific process in case of late registration request or when one’s become importer after the last deadine of May 2018. You may refer to ECHA website.

Distributors and downstream users are also concerned with chemical substances as risk of illegal use in case they continue to source in these substances after 31.05.18. They also have to check with suppliers that the substances contained in the utilized products or items have been correctly registered.

Do the chemicals needed for lightstick products require registering with REACH?

Yes, there is one substance essential to the manufacture of lightstick and Cyalume is the only manufacturer to be registered for it with REACH. The other manufacturers / importers of lightsticks are not compliant with REACH to date and are punishable with fines and penalties.

In total there are three substances in a chemical light product that will require registration with REACH. The annual volume of each substance depends of the total number of manufactured products, and to each annual volume does correspond a registration deadline with REACH, but today all these deadlines have passed, so any chemical substance has to be registered.

I only buy a small number of lightsticks/products as an importer/distributor to use/resell, how can this affect me?

It is not based on just the amount you buy, but rather the total number of lightsticks/products your supplier imports or your manufacturer makes.

WARNING: From 200 000 lightsticks/year imported in European Union, an importer is obliged to register at least one of the chemical substances contained in a lightstick.
Even if you are not an importer of these products and in these quantities, and even if you are at the end of the supply chain of these lightsticks, it is your responsability to check that the products that you purchase to resell or for a definitive use have been correctly registered with REACH at the risk being in infrigement.

Who does REACH affect?

Everyone in the supply chain is concerned: from the manufacturer to the customer or end user. All the companies in the European Economic Area (EEA= European Union + Norway + Iceland + Lichtenstein) that manufacture, import or use chemical substances in their activities are concerned by REACH. Chemical industry, manufacturing or industrial industries, artisans… all areas are concerned.

The related substances can be:

  • as such (as a solvent or a metal)
  • in mixture (cleaning product containing this solvent, alloy)
  • or contained in an item such as a lightstick

REACH sets the most ambitious chemical safety standards worldwide. Manufacturers and importers have to demonstrate how a substance or product they place on the market can be used safely and communicate the risk management measures to their customers.

Who has to comply?

All actors in the supply chain of a chemical product have an important role to control the risks and ensure the safe use of chemicals. Therefore, the requirements of REACH, apply to all of them.

You have to register on ECHA if you are:

  • a manufacturer or an importer in EU of substances as such or contained in a mixture
  • a manufacturer or an importer in EU of items meeting the listed criteria in “Guidance on requirements for substances in articles”
  • an “only representative” established in EU and designated by a manufacturer, a formulator or an item manufacturer established outside the EU to comply with the registration obligations of importers.

If you are not part of the above mentioned categories and are not directly concerned by REACH registration, you have still the responsability to check that your suppliers in earlier stages of the supply chain are compliant with these types of registration. If the product you purchase or use does contain chemical substances that have not been registered, you are in breach.

Cyalume Chemical Substances Reach

What part do I play in the REACH supply chain?

The actors in the supply chain of chemical substances as such, in mixtures intended to be resold or finished goods (such as lightsticks) are defined by REACH as follows:

  1. Manufacturer means any natural or legal person established within the EU who manufactures a chemical substance* within the EU destinated to use it on its own or to supply it to third parties (also for export).
  2. Importer means any natural or legal person established within the EU who imports a chemical substance* in EU. If you purchase any type of products coming from outside EU/EEA, you might have probably some responsabilities within the context of REACH.
  3. Distributor means any natural or legal person established within the EU, like a retailer who only stores and places on the market a substance*, on its own or in a mixture for third parties.
  4. Downstream user means any natural or legal person established within the EU, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of their industrial or professional activities. Most of the companies use chemical substances, at times even unconsciouly; you have to check your obligations if you handle chemical substances in your industrial or professional activity. Some may be your responsabilities within the context of REACH.
  5. End-users means any person who uses without any trade chemical substances* as part of its industrial/professional activity.
  6. Only representative means any any natural or legal person established within the EU, designated by a manufacturer, a formulator or an item manufacturer located outside the EU for the purpose of acting as a registrant established in the Union and comply with the registration obligations due by importers.

*by extension it may also refers to mixture of chemical substances or finished products (like lightsticks).

What are my responsibilities as a distributor of chemical products?

The main priority for distributors is to ensure that the chemical products which they supply, comply with the registration, authorisation and restriction requirements of REACH.

Two situations however can change the role of a distributor:

  • When they supply a chemical product directly from outside the EU they are importers
  • When they re-package a chemical product or re-label it to include their brand, they are considered as downstream users.

As a distributor or supplier do I have to supply safety advice to the end users?

Suppliers of finished products must be able to provide use precautions of a product to industrial or professional users.

In case a product contains a chemical substance listed in the Candidate List*, suppliers of items containing such substance in a concentration above 0.1% (weight by weight) have to provide enough information to allow the safe use of the article to the recipients of the article.

The supplier of the article has to provide this information within 45 days, free of charge.

Please note: the DBP Dibutylphthalate that is still one of the most commonly used solvents to produce chemiluminescent products (lightsticks), is part of this Candidate List of chemical substances. Cyalume substituted the DBP in 2013 for a solvent without phthalate.

This can lead to additional pressure on industry to respond to consumer demands for safer products by replacing substances of very high concern with safer alternatives.

*Candidate List: in the REACH registration process, a chemical substance must pass the authorization process if this substance is considered as a substance of very high concern (SVHC). The authorization process requires a very strict and supervised use of such chemical substance, that may cause serious irreversible human health and ecological effects.
The subtsances identified as of very high concern in accordance with the provisions of rule 57 (SVCH substances) are listed, after public consultation, in the List of substances that are candidate for authorization process. This Candidate List is published by ECHA. The substances listed in this list are subject to an obligation of communication from suppliers.

What are the chemical substances concerned by restrictions? by the Candidate List?

The restriction of chemical substances presenting an unacceptable risk

Restrictions limit or prohibit manufacture, place on market or use of certain substances that pose an unacceptable risk for human health and environment.When a Member State, or ECHA upon request by the Commision, considers that the place on market or the use of a chemical substance can lead to a risk that is not adequately controlled and that requires further action at EU-level, it prepares a file in order to register this substance in Annex XVII of REACH.

After these public consultations and ECHA advice, the European Commission and the State Members decide together about including the substances to Annex XVII. Inclusion to Annex XVII specifies exactly what are the restrictions on the substance (manufacture/place on market, operating conditions).>
The whole list of substances subjected to restrictions can be found on the ECHA website.

 

The Candidate List of substances of very high concern (SVHC)

As mentioned above, the substances identified of very high concern are listed in the Candidate List for authorization process. The candidate list of substances of very high concern (SVHC) can be found on the ECHA website.

Am I allowed to distribute any kind of chemiluminescent product on the European market?

In the European Union, every distributor is responsible for ensuring that the products they put on the market conform to European standards. Note that products from Asia may contain dibutylphthalate (DBP), a chemical that is prohibited in Europe. These products cannot be sold legally in Europe.

Cyalume confirms that none of the products it manufactures contains DBP and also that it has developed a phthalate-free formula. All the substances contained in our products, requiring registration according to the REACH regulation, have been declared in the allotted times. As a retailer, you are responsible for ensuring that your suppliers operate according to REACH requirements.

Is there a helpdesk for REACH?

Yes, contact your national REACH helpdesk on the ECHA website!