REACH: the second list of ‘very harmful’ chemicals is proposed

The chemicals comprise substances that negatively affect human health (carcinogenic, mutagenic, and/or reprotoxic, or CMR) and that negatively affect the environment (persistent, bioaccumulative, and toxic (PBT) and very persistent and very bioaccumulative (vPvB)). The number of proposals contrasts with the number of chemicals already known to fulfill the criteria of very high concern.

Ten of the chemicals are on the Substitute It Now! (SIN) list, a list of chemicals compiled by the International Chemical Secretariat (ChemSec) in collaboration with HEAL and other non-governmental organizations, and which uses REACH’s criteria for substances of very high concern. These chemicals include:

• Five compounds that are anthracene oil and anthracene oil-derivatives, which are persistent, bioaccumulative, and toxic compounds used primarily as pesticides

• acrylamide, a carcinogen and mutagen that is used in water treatment and also is created naturally when starchy foods are heated or fried

• 2,4-dinitrotoluene, a carcinogen that is used as a plasticizer and as an explosive

• Three lead chromate and related derivatives, which are pigments that are carcinogens and reproductive toxicants

• Diisobutyl phthalate, a reproductive toxicant used as a plasticizer, and tris(2-chloroethyl)phosphate, a flame retardant that is toxic to reproduction, were only recently classified as health hazards and so have not yet been added to the SIN list.

Twelve of the chemicals proposed are on the Trade Union Priority List compiled by the European Trade Union Confederation (ETUC), which emphasizes chemicals that are of particular concern for occupational health. In addition to all but one of the chemicals also seen on the SIN list, these twelve include:

• Coal tar pitch, a carcinogen that is also persistent, bioaccumulative, and toxic.

What comes next?

Public comments about any of the 15 chemicals can be either general (for example, your support for its nomination and adoption); or specific to the ‘justification’ submitted for placing this chemical on the candidate list (see the related document on the ECHA website, called the Annex XV report). The comments can also pertain to use, exposure, alternatives and risks; or any additional (including confidential) information you may have.

If you wish to submit comments, we suggest you refer to the dossier submitted by the nominating Member State for that chemical. The dossier may omit information that is important for how the chemical is subsequently handled in REACH: for example a decision on ranking this chemical prior to others for undergoing the Authorisation procedure, or whether it can be treated as a chemical with an identifiable safe threshhold (subject to more lenient requirements to obtain an authorisation).

Please note that in the individual dossiers occasionally the sentence ‘this is not relevant for this dossier’ may appear. This may indicate that this section has already been dealt with under the listing of that substance in Annex I of Directive 67/548 where Carcinogens, Mutagens and Reproductive Toxins (CMRs) category 1-3 are listed. Or it may indicate that this section is not relevant for the dossier when used for the Candidate List, as the dossier has a standard format that is also applicable to two other REACH procedures.

After the public consultation ends, the ECHA’s Member State Committee will review the proposals and determine if the chemicals will be added to REACH’s candidate list. Chemicals on the Candidate list may eventually be added to the Authorization list for regulatory purposes.

Why is the candidate list important?

Once a substance is on the candidate list, the consumer right-to-know clause kicks in - consumers can ask whether a candidate substance is in a product they are buying and must receive an answer within 45 working days (this applies to European consumers). Also companies know ahead of time which chemicals will eventually be put through the authorisation process and can start arranging to stop using them, an early signal to encourage innovation, green chemistry and safer substitutes.

More information:

• ECHA press release
• European Trade Union Confederation Priority List
• Substitute It Now list