COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Disclaimer: Comments provided during the consultation are made available as submitted by the commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain confidential information. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a substance of very high concern. 

Substance name: Dibutyl phthalate
CAS number: 84-74-2
EC number: 201-557-4

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Endocrine disrupting properties (Article 57(f) – environment)

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5768
2023/10/10	Food Packaging Forum Foundation,
International NGO,
Switzerland		We would like to thank you for sharing this information. At this stage of SVHC identification, exposure information is out of scope	
		Attachment: 5768_dibutyl phthalate detected in FCMs.xlsx
		
5791
2023/10/16	European Plasticisers (a sector group of Cefic),
Industry or trade association,
Belgium		Thanks for your comments. We acknowledge that DBP is already on Annex XIV of the REACH regulation and that due to this the uses have been reduced. For the identification as SVHC this information is out of scope. 	
		Attachment: 5791_European Plasticisers_public consultaton_DBP SVHC_Oct_final.pdf
		
5809
2023/10/16	ANSES,
National Authority,
France	Please find below additional specific comments for your attention:
P.12 Bioactive assays were retrieved from CompTox database and are indicative of EAS modalities, although more details would be necessary to appreciate the relevance of this information (Name of the assay, concentrations tested, AC50 value, positive and negative controls,…).
P.14 Please correct results reporting in table 4 for ER transactivation assays (Jobling 1995 and Harris 1997)
	We agree with the FR comments on the CompTox database. However, the database did not provide more reliable information than public literature. We deleted the description here. In this dossier, we focus on the EAS activity of public literature, which provide more solid evidence.
Thanks for the comment. Results have been corrected based on the two original papers.	

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5759
2023/09/27	Norway,
Member State	The Norwegian CA supports that Dibutyl phthalate should be identified as a substance of very high concern and should be included in the Candidate List.

We would also like to mention some further monitoring data that may be relevant as supporting information:
- Screening programme 2019: https://www.miljodirektoratet.no/sharepoint/downloaditem/?id=01FM3LD2WQPCTJHRCVKBB2IE6NPKE47T5L
- Environmental Contaminants in an Urban Fjord: 2021: https://www.miljodirektoratet.no/publikasjoner/2023/januar-2023/environmental-contaminants-in-an-urban-fjord-2021/
	Thank you for your kind support.
Thanks for the references, which have been added.	
				
5768
2023/10/10	Food Packaging Forum Foundation,
International NGO,
Switzerland		See response above	
		See the corresponding embedded attachment in table 1 of Part I: 5768_dibutyl phthalate detected in FCMs.xlsx		
5775
2023/10/11	Health and Environment Alliance (HEAL),
International NGO,
Belgium	The Health and Environment Alliance (HEAL) thanks the Dutch competent authorities for their proposal to identify Dibutyl phthalate as a substance of very high concern (SVHC) under REACH article 57(f) due to endocrine disrupting properties for the environment meeting the ELoC criteria. We fully support this proposal, based on a well prepared and documented dossier.

We concur with the dossier submitter regarding the following:
- The substance is already classified as reprotoxicant 1B under Regulation 1272/2008;
- The substance has already been classified as a SVHC under REACH article 57(c) due to its reprotoxic properties;
- The substance meets the WHO definition of an endocrine disruptor by showing population relevant effects on reproduction (sex ratio, fecundity, malformation, growth of the offspring of exposed animals in existing studies), endocrine activity (ER binding and transactivation, androgenic and anti-androgenic activity in both in vitro and in vivo studies), the demonstration of the high plausibility between the effects observed and the endocrine activity;
- The ELoC criteria are met: the sexual development and reproduction effects observed are population relevant and irreversible (malformation, survival rate, fecundity effects), also potentially affecting the ability of the fish population to reproduce with long-term effects on the ecosystems.

For all the reasons above, we consider that the substance meets the criteria to be identified as a SVHC under REACH article 57(f).
	Thank you for your kind support	
				
5791
 2023/10/16	European Plasticisers (a sector group of Cefic),
Industry or trade association,
Belgium		See response to comment above	
		See the corresponding embedded attachment in table 1 of Part I: 5791_European Plasticisers_public consultaton_DBP SVHC_Oct_final.pdf		
5795
2023/10/16	Sweden,
Member State	We thank the Netherlands for this proposal. We support the proposal to identify the substance as SVHC, meeting the criteria of Article 57(f) for the environment. We agree, based on the provided data in the dossier, that this substance has endocrine disrupting properties for which there is scientific evidence of probable serious effects to the environment, which gives rise to an equivalent level of concern, according to the criteria of article 57(f) in REACH, to those of other substances listed in points (a) to (e) of Article 57 REACH.

In Summary, page 6, and in section 6.3.3, page 28:
We propose to modify the following sentence:
Overall, developmental and reproductive toxicity tests in rodents provide supporting evidence that the adverse effects elicited by DBP are population relevant and can be used to strengthen the conclusion that DBP is an ED for the environment.
to
Overall, developmental and reproductive toxicity tests in rodents provide evidence that the adverse effects elicited by DBP are population relevant and can be used, in parallel to the data from the aquatic species, to conclude that DBP is an ED for the environment.

In section 6.3.1 (page 26)
We propose to modify the following sentence:
Overall, developmental and reproductive toxicity tests in rodents provide supporting evidence that is potentially population relevant and can be used to strengthen the conclusion that DBP as an environmental ED for mammals in the environment cannot be excluded.
to
Overall, developmental and reproductive toxicity tests in rodents provide evidence that the adverse effects elicited by DBP are population relevant and can be used, in parallel to the non-mammalian data, to conclude that DBP is an environmental ED.
	Thank you for your kind support.

We agree that the available information is sufficient to conclude that there is a plausible link between the anti-androgenic activity and reproductive effects observed in rodent. We therefore agree with the revision proposed and extend section 5.2.4, 5.2.5, 6 with the relevant information. To further substantiate the conclusion we have added a reference to Mahood et al (2007), who found after in utero exposure a dose dependent decrease in fertility of male offspring rats.	
				
5799
2023/10/16	ChemSec,
International NGO,
Sweden	ChemSec supports the additional identification of the SVHC Dibutyl Phthalate as an endocrine disrupting chemical for the environment. The dossier illustrates well how the reprotoxic effects in fish are linked to effects on the endocrine system.	Thank you for your kind support.	
				
5805
2023/10/16	Environment Agency Austria,
Other contributor,
Austria	The identification of dibutyl phthalate as an endocrine disruptor for the environment including the assessment of the equivalent level of concern is supported. The available mammalian and fish data are conclusively showing EAS mediated activity and adversity and provide sufficient information for a plausible link between those.

Suggestions for improvement:
Page 28:8 Rephrasing of a sentence in the chapter on derivation of safe level
It is suggested to rephrase the following sentence:  “A considerable amount of fish toxicity studies covering the whole life cycle of fish are available.” into “A considerable amount of fish toxicity studies covering the whole life cycle and including testing of endocrine mediated adverse effects are available.”
Page 17: Typo correction:  In the last sentence describing Bhatia et al. (2014b) a “T” is missing in the first word.
	Thank you for your kind support.

Thanks for the suggestion.
Changes were made according to the suggestion on p17 and 27. 	
				
5809
2023/10/16	ANSES,
National Authority,
France	ANSES agrees with the identification of dibutyl phthalate as SVHC  under Article 57(f) – environment )based on endocrine disrupting properties for the environment.
The assessment targeted EAS modalities, endpoints that are conclusive for endocrine disrupting properties. However, T-modality was investigated in the previous SVHC document  in relation to the environment. Clarifications might be useful to understand if the assessment of T-modality did not proceed due to a lack of data, data of poor quality or data available and of good quality but not fulfilling the WHO/IPCS definition (WHO/IPCS, 2002) of an endocrine disruptor as interpreted by the EC ED EAG (JRC, 2013).
	Thank you for your kind support.
This dossier was  targeted to EAS modalities. After a targeted literature search we found a study of Kamel et al 2022, who found strong evidence that DBP affects the thyroid axis leading to an accelerated metamorphic development. It is therefore valid to conclude that DBP is an environmental ED via T modality. 
We have included the studies from the previous proposal and added the study of Kamel et al (2022) and extend section 5.2.4, 5.2.5, 6 with the relevant information. 

.	
				
5819
2023/10/16	CHEM Trust Europe,
International NGO,
Germany	CHEM Trust supports the inclusion of Dibutyl phthalate (DBP) in the REACH candidate list as an endocrine disrupter for the environment in addition to being an ED for human health. The annex XV dossier summarises the scientific evidence on EAS endocrine activities and adversity from in vitro tests and fish studies and establishes  the plausible link. DBP clearly gives rise to an equivalent level of concern according to REACH article 57 f because it has been shown that  exposure during sensitive time windows of sexual development may cause irreversible developmental programming effects leading to severe effects on development and reproduction, regarded as particularly serious in relation to wildlife species.	Thank you for your kind support.	
				
5822
2023/10/16	European Environmental Bureau,
International NGO,
Belgium	The EEB welcomes the proposal by The Netherlands to identify Dibutyl phthalate (DBP) as substance of very high concern in accordance with Article 57(f) of Regulation (EC) 1907/2006 (REACH) because of its endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and the environment which gives rise to an equivalent level of concern to those of other substances listed in points (a) to (e) of Article 57 REACH. The ED effects observed in rats and fish include adverse effects on sexual development, reproduction, survival and growth of offspring and these effects are considered relevant at the population level. There is strong evidence of EAS activity demonstrated by in vitro and in vivo studies and the observed adverse effects are plausibly linked to EAS mode of action. The entry for DBP in the candidate list and Annex XIV should be amended to specify its endocrine disrupting properties for the environment, in addition to its toxicity for reproduction and its endocrine disruption properties for human health.	Thank you for your kind support.	

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5768
2023/10/10	Food Packaging Forum Foundation,
International NGO,
Switzerland	The Food Packaging Forum (FPF) is a charitable, science-based organization at the science policy interface. FPF is dedicated to raising awareness for hazardous chemicals in, and environmental impacts caused by, all types of food contact materials and articles (FCMs). As our expertise is mainly on chemicals in food packaging, we focus our remarks on this aspect to provide context on any follow-up to the listing of dibutyl phthalate as an SVHC Candidate.
Dibutyl phthalate has been measured in food contact materials.
We found evidence from 153 studies demonstrating the presence of dibutyl phthalate in migrates from FCMs or that have been directly extracted from food packaging or other food contact articles (Geueke et al., 2022). These 153 studies measured dibutyl phthalate in aluminum, steel, multimaterial, cork, rubber, silicone, wood, paper/board, recycled paper/board, multilayer plastic, as well as polyamide (PA), polycarbonate (PC), polyethylene (PE), polyethylene terephthalate (PET), recycled PET, polypropylene (PP), polystyrene (PS), and polyvinyl chloride (PVC) plastics.

The studies in question were published between 1988 and 2023 demonstrating long term continuous consumer and environmental exposure to this chemical that the authorities in the Netherlands have concluded is endocrine disrupting for the environment.

Concerns for EU FCM safety
Dibutyl phthalate is included in Annex 1 of EU 10/2011 on plastic materials and articles intended to come into contact with food, meaning it is allowed in plastic FCMs in Europe. Yet, as mentioned above, it is known to migrate out of a diverse array food packaging materials which has effects for both humans and any environment where littered packaging ends up.
REACH demands the substitution of SVHCs by safer alternatives in industrial products, processes, and in consumer articles solely based on their intrinsic hazard properties, not based on their risk (where both hazard properties and exposure levels would be taken into account). Authorization under REACH can be granted for specific uses and time periods in case the applicant demonstrates that the risk from using the substance is adequately controlled. Alternatively, the applicant can show that socio-economic benefits of using the substance outweigh the risks and that there are no suitable alternative substances or technologies. However, the human health effects of FCMs are excluded from the REACH authorization process.
A stricter ban of SVHCs from all possible areas of use, including FCMs, would further reduce the overall burden of these chemicals, facilitate compliance with Article 3 of the FCM Framework Regulation and help to improve public health.
Thank you for the chance to provide input into the consideration of candidate SVHCs.

Best regards,
FPF staff

Other resources
Geueke B, Groh KJ, Maffini MV, Martin OV, Boucher JM, Chiang Y-T, Gwosdz F, Jieh P, Kassotis CD, Łańska P, Myers JP, Odermatt A, Parkinson LV, Schreier VN, Srebny V, Zimmermann L, Scheringer M and Muncke J (2022) Systematic evidence on migrating and extractable food contact chemicals: Most chemicals detected in food contact materials are not listed for use. Critical Reviews in Food Science and Nutrition, 1-11. https://doi.org/10.1080/10408398.2022.2067828.
Geueke, B., Wagner, C., and Muncke, J. (2014) Food contact substances and chemicals of concern: a comparison of inventories, Food Additives & Contaminants: Part A, 31:8, 1438-1450, DOI: 10.1080/19440049.2014.931600
Geueke, B., and Muncke, J. (2018) Substances of Very High Concern in Food Contact Materials: Migration and Regulatory Background. Packag. Technol. Sci., 31: 757–769. https://doi.org/10.1002/pts.2288.

Studies detecting dibutyl phthalate in FCMs
Please see the spreadsheet attached to this comment
	See response above	
		See the corresponding embedded attachment in table 1 of Part I: 5768_dibutyl phthalate detected in FCMs.xlsx		
5791
2023/10/16	European Plasticisers (a sector group of Cefic),
Industry or trade association,
Belgium	Please see the attached document.	See response to comment above	
		See the corresponding embedded attachment in table 1 of Part I: 5791_European Plasticisers_public consultaton_DBP SVHC_Oct_final.pdf