13 Aug 2018
EU Reach plays a vital role in keeping a check on the risks of hazardous materials that affect human health and the environment. We bring you a list of FAQ’s to help you stay updated on regulatory compliance and be compliant in all forms.
REACH is a new European law regulating the use and production of chemical substances.
Those who import or produce a new chemical must pay the costs for the testing of the chemical.
Animal testing will increase significantly due to all the chemical tests that have to be carried out. However, officials from the European Commission have stated that an increase in animal testing of almost four million more animals was not “ethically defensible” and that there are plans to reduce this high number by almost 70%.
Within the 11 years of implementation of REACH, approximately 30,000 chemicals have to be registered. Those being most hazardous or existent in the largest quantity will go first.
Substances that are one of the following:
The general aim of REACH is to replace these potentially very hazardous substances by safer alternatives whenever possible.
If this is not possible, in exceptional cases hazardous substances can be authorized if the registrant can prove that
Every such authorization is however limited in time in order to encourage research for an alternative substance. If the potentially hazardous substances are used for R&D purposes, exemptions can be granted.
REACH has the power to ban either the chemical or even the entire product containing the chemical.
No. The REACH regulation is valid only for chemical substances that are produced in or imported into the EU. It is – unless specific safety regulations apply – not valid for chemicals within a finished product. Thus, for imported products there is still no safety guarantee.
Animal protesters fear that the REACH regulation may lead to an increase in animal testing. Economists are concerned that the regulation might hamper global trade, as there is a possibility that international companies might consider moving away from Europe to avoid red tape and additional costs related to the regulation. According to the Commission animal testing will be reduced and no economic negative implications have to be feared.
No. Polymers, a group of chemicals which includes plastics, do not have to be registered at the moment, as there is currently no easy, cost-effective way to test them.
Yes. You will be able to download a free simplified version of the International Uniform Chemical Information Database (IUCLID 5.0), which is also available as a commercial version including the ORACLE management system. Companies also have the possibility to outsource the submission through IUCLID.
Yes, if the preparation volume that you want to import equals or is bigger than 1 tonne per year.
This means that for every single substance a registration needs to be submitted (one substance – one registration).
No, food is not an article, substance or preparation. Cosmetics were originally excluded from REACH, but in order to increase customer consumer confidence they were included afterwards. REACH is now supposed to function hand in hand with the Cosmetics Directive.
These are substances that were considered as polymers under the EINECS regulation, but no longer fall into this category due to a change of definition of “polymer” in the directive 92/32/EEC. These now need to be registered in accordance with REACH. Normal polymers are exempted from being registered and evaluated. However, they may still be subject to authorisation or even restriction.
Failure to register means that the substance must not be imported or manufactured within the EU.
A RIP is REACH Implementation Project, with 11 years’ project timeline till 2018.
A phase-in substance is a substance that has been listed in EINECS and/or manufactured in the EC, but never actually been placed on the market during the last 15 years. No-longer polymers are also phase-in substances.
A non phase-in substance is a completely new substance that has neither been used nor registered in the market before the entry of force of REACH.
Any non phase-in substance must be registered before it can be used in a manufacturing process.
A chemical safety assessment (CSA) is a part of the registration dossier that must be prepared, if the import of a substance is bigger than 10 tonnes a year. It should list the hazards of the substances and assess their risks.
The Chemical Safety Report (CSR) completes the risk assessment by stating how the risks are adequately controlled.
The risk assessment needs to be performed for all different exposure scenarios, that is: for all ways in which the substance is manufactured or used, including the different ways of control the manufacturers or importers exert in the process.
The manufacturer or importer communicates all such exposure scenarios to the downstream users in the safety data sheet (SDS).
The downstream users should then assure themselves that their particular use of the substance is covered by the exposure scenarios identified. If not already covered, the downstream users can identify their use to the manufacturer/importer, and the manufacturer/importer can then choose to include this use in the CSA.
If a downstream user chooses not to reveal their use of a particular substance to the importer or manufacturer, then they must prepare their own CSA.
If a substance or preparation is considered hazardous in accordance with Directive 67/548/EEC or 1999/45/EC or if the substance is a PBT or a vPvB, the supplier must prepare a SDS (safety data sheet). The preparation of such an SDS is independent of the amount of the substance.
Yes, if you and another registrant want to register the same substance, you can submit the information on the substance and on its classification together.
The CSR can also be submitted jointly. The information must be submitted by one main registrant on behalf of the others.
The other registrants need to submit information on their company details, production volumes etc. individually.
Manufacturers and importers have the possibility to opt out of joint registration arrangements if this would mean excessive cost for them, if they disagree with the lead registrant on the data to be submitted or if a loss of confidential information would cause severe commercial damage.
Then you need to register for all substances contained in an article, if both of the following is true:
In case you are dealing with chemicals already considered hazardous – like CMRs, PBTs or vPvBs – then you will have to register the substance, if both of the following holds true for you:
You need to inform the ECHA about the following:
Yes, they do and thus they need to be registered. However, minerals and ores are exempted from registration unless they are chemically modified.
The registration rights belong to you for 10 years. After that period the data will be made available for all other registrants.
Pre-registration is a system for the registration of phase-in substances, i.e. the substances which have already been in the EU, but have not entered the commercial market yet and have not been tested for safety either.
During the time of pre-registration, potential registrants must submit certain information to the ECHA, including information on the identity of the substance, the potential registrant and the envisaged deadline for registration.
From this, a Substance Information Exchange Forum (SIEF) will be created for potential registrants of the same substance. The aim of this forum is enabling those registrants to share data on exposure assessment tests.
Yes, you need to pre-register preparations of phase-in substances and register the preparation substances, if the volume of the substance in the preparation is more than 1 tonne per year.
SIEF is the abbreviation for Substance Information Exchange Forum. This Forum was created to share data and costs between the different registrants as well as to reduce animal testing by data share.
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