Chemical name: 1,2-Benzenedicarboxylic acid, butyl phenylmethyl ester, 2-O-benzyl 1-O-butyl benzene-1,2-dicarboxylate

Final regulatory action has been taken for the category: Industrial

Final regulatory action: The chemical is Severely Restricted

Use or uses prohibited by the final regulatory action:

Industrial chemical.

Use or uses that remain allowed:

Pursuant to Regulation (EC) No 1907/2006 (REACH Regulation), only certain uses are exempted from the authorisation requirement, e.g. uses as intermediates or for scientific research and development activities, as described in the document Generic exemptions from the authorisation requirement [https://www.echa.europa.eu/documents/10162/13640/generic_exempt_auth_2020_en.pdf/d39ae442-c58f-4d51-2e69-71b83580afaf]. According to the exemption concerning mixtures, which is mentioned in Section 1 of the linked document, the substance can be present in mixtures below 0.3% weight by weight (generic concentration limit specified in Regulation (EC) No 1272/2008). However, this exemption is constrained by entry 51 of REACH Annex XVII, restricting its use in toys and childcare articles (individually or in any combination of the phthalates bis (2-ethylhexyl) phthalate (DEHP, EC No 204-211-0), dibutyl phthalate (DBP, EC No 201-557-4), diisobutyl phthalate (DIBP, EC No 201-553-2)) in a concentration equal to or greater than 0.1% (as of 7 July 2020 this restriction applies to any articles). From the exemptions specific to certain intrinsic properties mentioned in Section 2, those referring to Article 57 (c) and to hazards to human health apply for benzyl butyl phthalate (see Section 2.4.2.1 below for intrinsic properties of the substance).

In addition, exempted (categories of) uses specified in the Annex XIV entry of benzyl butyl phthalate are uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC.

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action:

By Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation (EC) No 1907/2006, benzyl butyl phthalate was included into Annex XIV (Authorisation List) of Regulation (EC) No 1907/2006 (REACH Regulation), which contains substances of very high concern that are subject to authorisation.

The listing of benzyl butyl phthalate in the Authorisation List has the effect that any use of this substance after 21/02/2015 (the Sunset Date) is prohibited (except for exempted uses as described in Section 2.3.2 of this document), unless a company submits an application for authorisation and the authorisation is granted. Since no applications for authorisation have been submitted to date only the exempted uses remain allowed. Hence, the final regulatory action severely restricts the use of benzyl butyl phthalate.

The reasons for the final regulatory action were relevant to: Human health

Summary of known hazards and risks to human health:

Benzyl butyl phthalate has been classified under Regulation (EC) No 1272/2008 (CLP Regulation) as Toxic for Reproduction, Category 1B, H360Df ("May damage the unborn child. Suspected of damaging fertility."), which is the basis for the identification as substance of very high concern under Article 57 (c) of Regulation (EC) No 1907/2006 (REACH Regulation).

Summary of data for toxicity for reproduction

Benzyl butyl phthalate is found to adversely affect the reproductive organs in experimental animal studies which may affect fertility. Furthermore, the substance is found to be a developmental toxicant and to possess anti-androgen like properties in experimental animal studies. Available human data support the hypothesis that prenatal phthalate exposure at environmental levels may affect male reproductive development in humans.

Reproductive effects of benzyl butyl phthalate and its major metabolites monobutyl phthalate and monobenzyl phthalate in rats following oral administration both by gavage or in the diet have been investigated in studies of different duration (from 4 days to 26 weeks, and in 2-generation studies). The main effects reported include a decrease in the relative weight of testis, damage to the testis, epididymis, prostate, seminal vesicle and to reduced epididymal sperm concentrations, and at high concentrations of benzyl butyl phthalate reduced fertility, in addition to increases in relative liver and kidney weights.

In the developmental toxicity studies in rats and mice after exposure to benzyl butyl phthalate or its major metabolites developmental toxicity in offspring included prenatal mortality, reduced fetal weight, and malformed foetuses.

Expected effect of the final regulatory action in relation to human health:

Avoidance of risk for human health from the use of benzyl butyl phthalate.

Date of entry into force of the final regulatory action: 21/02/2015