EU Bans 6 Substances After 2014-2015, Unless Use Authorized Under REACH
On February 17, 2011, the European Commission placed the first six substances on the “authorization list,” known as Annex XIV under the European Union’s REACH1 regulation (No 1907/206). This means that these six substances (including 3 phthalates) cannot be used or placed in the European Union market after certain dates, unless an authorization has been granted for their use.
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(The European Chemicals Agency (ECHA) recommended in June 2009 that these six substances (as well as a seventh2) be subject to REACH authorization. See ITT’s Online Archives or 06/25/09 news, 09062530, for BP summary.)
Each Substances Has Sunset Date Ranging from 2014-2015
For each substance listed, a "sunset date" is provided, ranging from 2014 to 2015. From this date, the substance may only be placed on the market or used in the EU if an authorization has been granted or an application for authorization has been made before the "latest application deadline."
Restrictions Apply Regardless of Tonnage
The EC states that the bans on these six substances apply regardless of the tonnage at which the substance is placed on the market or used, as no lower limits are provided for the authorization requirement.
Banned Substances Include 3 Phthalates, Flame Retardants, Etc.
The six substances added to Annex XIV and subject to “REACH Authorization” include:
| Substance Name & (Sunset Date) | CAS Number (EC Number) | Uses |
|---|---|---|
| 4,4’ Diaminodiphenylmethane, (MDA) (07/21/14) | 101-77-9 (202-974-4) | Hardener used in epoxy resins, adhesives |
| Benzyl butyl phthalate (BBP) (01/21/15) | 85-68-7 (201-622-7) | Plasticizer used in polymer products, and in particular in PVC for flooring applications, in textile and leather coating, as well as in various other preparations such as sealants, coating and inks or adhesives |
| Hexabromocyclododecane, (HBCDD) (07/21/15) | * | Flame retardant used for example in polystyrene, which is then further processed for the production of insulation panels/boards or packaging products, and in textile applications |
| 5-tert-butyl-2,4,6-trinitro-m-xylene (07/21/14) (Musk xylene) | 81-15-2 (201-329-4) | Fragrance enhancer used in detergents, fabric softeners, fabric conditioners, etc |
| Bis(2-ethylhexyl) phthalate (DEHP) (01/21/15) | 117-81-7 (204-211-0) | Plasticizer used in a wide range of PVC and other polymers applications, such as flooring, roofing, coated fabrics, medical devices or primary packaging of medicinal products, as well as in various preparations such as for example sealants, adhesives and inks |
| Dibutyl phthalate (DBP) (01/21/15) | 84-74-2 (201-557-4) | Specialty plasticizer used in particular in various polymer (PVC/non-PVC) applications such as floor covering or primary packaging of medicinal products and as a component of various preparations such as adhesives or paints |
*Several CAS/EU No’s are given. (See Annex in source document for details.)
The 3 Phthalates Exempt if Used in Immediate Packaging of Medicinal Products
The EU notes that under REACH, certain listed uses of the substances can be excluded from the authorization requirement. In this case, the EU is already exempting for the three subject phthalates, their use in the immediate packaging of medicinal products.
Those Seeking Authorization Must Demonstrate How Risks Are Controlled, Etc.
Those seeking authorization to use such chemical substances must submit an application which demonstrates how risks are controlled for specific uses of the chemical substances, an analysis of possible alternative substances including the suitability of their use, etc.
Authorization applications must be submitted to ECHA. The Agency's Risk Assessment Committee and Socio Economic Committee will then consider each application and submit their opinion to the European Commission. The final decision will be made by the European Commission.
1REACH entered into force on June 1, 2007, and is intended to streamline and improve the EU’s former legislative framework on chemicals. It stands for Registration, Evaluation, Authorization and Restriction of Chemicals and places greater responsibility on industry to manage the risks that chemicals may pose to health and the environment.
2The seventh substance, which is not currently being added to the Authorization list, was short chained chlorinated paraffins - SCCPs (characterized as PBT and vPvB)
EU press release, dated 02/17/11, available here.