Phthalates (pronounced THAL-ates) –covering orthophthalates and terephthalates – are the most commonly used plasticisers (US: plasticizers) in the world. In Europe, about one million tonnes of orthophthalates are produced each year – about 80% of the entire plasticisers market – of which approximately 95% are used to make flexible polyvinyl chloride (PVC). They can be found in a range of everyday items including electrical cables, hoses, flooring, wall coverings, coated textiles, luggage, sports equipment, roofing membranes, pool liners, footwear as well as life-saving medical devices such as tubing and blood bags. In addition, some phthalates are used in non-PVC applications such as coatings, rubber products, adhesives and sealants.
Orthophthalates are manufactured by reacting phthalic anhydride with alcohol(s) ranging from methanol and ethanol (C1/C2) up to tridecyl alcohol (C13),.They are broadly divided into two main distinct groups, with very different applications, toxicological properties, classification and legal requirements.
High molecular weight orthophthalates
High molecular weight (HMW) or high orthophthalates include those with 7-13 Carbon atoms in their chemical backbone, which gives them increased permanency and durability. The most common types of high orthophthalates include DINP, DIDP, DPHP, DIUP, and DTDP.
High orthophthalates represent about 70% of the European plasticisers market. Risk assessments have shown positive results regarding the safe use of this group of substances. They all have been registered for REACH and do not require any classification for health and environmental effects, nor are they on the Candidate List for Authorisation. High phthalates are not CMR, neither are they considered endocrine disruptors. Precautionary restrictions for toys and childcare articles which can be placed in the mouth exist for DINP and DIDP, based on liver effects at high doses observed in rat studies.
High orthophthalates are commonly used in PVC products such as wire and cables, flooring, truck tarpaulins, wallcoverings, self-adhesive films or labels, synthetic leather, coated fabrics, technical foils, roofing membranes and automotive applications.
Low molecular weight orthophthalates
Low molecular weight (LMW) or low orthophthalates are those with 3-6 carbon atoms in their backbone. The most common low orthophthalates include DEHP, DBP, DIBP and BBP. Low orthophthalates represent about 5% of the European market.
To date, eleven LMW orthophthalates classified as Category 1B reproductive agents have been identified as Substances of Very High Concern (SVHC) and placed on the REACH Candidate List. Two of them, DEHP, and DBP, , are currently undergoing Authorisation under REACH, and have been recommended by the ECHA Risk Assessment Committee and Socio-Economic Analysis Committee for Authorisation for specific applications and for specific companies only to supply (three specific companies only to supply DEHP and three other companies for recycling of PVC containing DEHP). If confirmed by the European Commission, this means that after February 2015, DEHP and DBP can be placed on the EU market only for those uses for which an authorisation has been granted to the specific applicants. Only seven applications covering uses of DEHP and DBP have been submitted. Since no applications for BBP and DIBP have been submitted, their use in the EU will be phased out by February 21, 2015.
Low orthophthalates are commonly used in medical devices (DEHP), general purpose PVC applications, adhesives and inks. Use of DEHP in medical applications is regulated by the Medical Devices Directive and not by REACH i.e. there is no need for REACH Authorisation for DEHP in medical applications – it can continue to be used subject to the Medical Devices Directive.
There are other kinds of orthophthalate plasticisers with less than 3 carbon atoms in their backbone (e.g. DMP, DEP,). They are used in very specific applications not related to PVC at all e.g. household and personal care products. For example, the non-classified orthophthalates, DMP and DEP are the most widely used in cosmetics in the EU. They have not been classified or restricted because they do not pose any risks for our health or the environment.
|Category||Name||Acronym||Cas||EC||Produced by members||Applications||Classification|
|Orthophthalate||Dimethyl phthalate||DMP||131-11-3||205-011-6||Adhesives||Not class.|
|Orthophthalate||Diethyl phthalate||DEP||84-66-2||201-550-6||Adhesives||Not class.|
|Orthophthalate||Di-n-propyl phthalate||131-16-8||205-015-8||Not class.|
|Orthophthalate||Di-n-butyl phthalate||DBP||84-74-2||201-557-4||Flooring, Automotive , Inks and waxes||Repr. 1B|
|Orthophthalate||Diisobutyl phthalate||DIBP||84-69-5||201-553-2||Automotive , Adhesives & Sealants, Inks and waxes||Repr. 1B|
|Orthophthalate||Benzyl butyl phthalate||BBP||85-68-7||201‐622‐7||Flooring||Repr. 1B|
|Orthophthalate||Di-n-pentyl phthalate||DNPP||131-18-0||205-017-9||Repr. 1B|
|Orthophthalate||Di-n-hexyl phthalate||DNHP||84-75-3||201-559-5||Repr. 1B|
|Orthophthalate||Diisohexyl phthalate||DHP||146-50-9||271-093-5||Repr. 1B|
|Orthophthalate||Dicyclohexyl phthalate||DCHP||84-61-7||201-545-9||Flooring, Toys||Repr. 1B|
|Orthophthalate||Diisoheptyl phthalate||DIHP||71888-89-6||276-158-1||Repr. 1B|
|Orthophthalate||Di-n-octyl phthalate||DNOP||117-84-0||204-214-7||Not class.|
|Orthophthalate||Diisooctyl phthalate||DIOP||27554-26-3||248-523-5||Not class.|
|Orthophthalate||Bis(2-ethylhexyl) phthalate||DEHP||117-81-7||204-211-0||Repr. 1B|
|Orthophthalate||Diisononyl phthalate||DINP||28553-12-0||249-079-5||Flooring, Wall coverings, Cladding and Roofing, Cables and wires, Film and sheet, Automotive , Tubes & Hoses, Coated Fabrics, Inks and waxes||Not class.|
|(second DINP line)||68515-48-0||271-090-9|
|Orthophthalate||Diisodecyl phthalate||DIDP||68515-49-1||271-091-4||Flooring, Cladding and Roofing, Cables and wires, Film and sheet, Automotive , Tubes & Hoses, Coated Fabrics, Inks and waxes||Not class.|
|Orthophthalate||Di(2-propyl heptyl) phthalate||DPHP||53306-54-0||258-469-4||Flooring, Wall coverings, Cladding and Roofing, Cables and wires, Film and sheet, Automotive , Tubes & Hoses, Coated Fabrics||Not class.|
|Orthophthalate||Diisoundecyl phthalate||DIUP||85507-79-5||287-401-6||Cladding and Roofing, Cables and wires, Automotive||Not class.|
|Orthophthalate||Diisotridecyl phthalate||DTDP||68515-47-9||271-089-3||Cables and wires, Automotive||Not class.|
|Orthophthalate||Benzyl C7-9-branched and linear alkyl phthalate||68515-40-2||271-082-5||Flooring, Adhesives & Sealants||Not class.|
|Orthophthalate||Di-C16-18 alkyl phthalate||90193-76-3||290-580-3||Cables and wires||Not class.|