Comments on ECHA’s Draft 9th Recommendation for 4,4-isopropylidenediphenol (Bisphenol A; BPA) (EC number: 201-245-8) and references to responses

The present document compiles the comments received during the public consultation on the draft 9th recommendation for inclusion of substances in Annex XIV of REACH for 4,4-isopropylidenediphenol (Bisphenol A; BPA) (EC number: 201-245-8). The public consultation took place between 5 September 2018 and 5 December 2018.

For each of the comments there is also a reference to specific section(s) of a document containing the responses to comments (“Response document”, available at https://echa.europa.eu/documents/10162/13640/9th_recom_respdoc_bisphenol_a_en.pdf). The responses in the Response document are arranged by thematic block and level of information (see more detailed explanations at the beginning of that document).

PUBLIC VERSION

Content
	
I - General comments on the recommendation to include the substance in Annex XIV
II - Transitional arrangements. Comments on the proposed dates
III - Comments on uses that should be exempted from authorisation, including reasons for that

I - General comments on the recommendation to include the substance in Annex XIV
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3298
2018/11/29	Germany,
Member State	The German CA welcomes the opportunity to comment ECHA’s draft for the 9th recommendation of substances for prioritisation for inclusion in Annex XIV. With regard to Bisphenol A (BPA), the German CA would like to state that currently the scoping of a restriction is explored which should serve to limit the emissions to the environment of BPA from the relevant sources. This restriction potentially comprises not only the uses subject to authorisation which contribute to the priority of the substance attributed by ECHA during the recommendation exercise but also e.g. emissions from uses potentially not subject to authorisation or arising from imported articles.

The German CA therefore considers a tailored restriction better suited than the eventual addition of the substance to Annex XIV to achieve a decrease of environmentally relevant emissions of BPA.	A.2.01. Claim that tailored restriction, which is currently explored by the German CA, is better suited to achieve decrease of environmentally relevant emissions than addition to Annex XIV	
				
3299
2018/11/29	Breast Cancer UK,
National NGO,
United Kingdom	Breast Cancer UK is a charity which aims to prevent breast cancer by promoting a healthy lifestyle and reducing exposure to carcinogenic and other hazardous compounds including endocrine disrupting chemicals. We are especially concerned about exposures to harmful chemicals during critical periods of development, including in utero, early childhood and puberty.

Breast Cancer UK supports strongly ECHA’s proposal to include BPA in the REACH Authorisation List. For many years we have been calling for a ban on the use of BPA in food contact materials and everyday items such as polycarbonate plastics (e.g. water bottles), epoxy resins and till receipts.

As the supporting draft background document states BPA is now classified as a substance of very high concern (SVHC) as it is toxic for reproduction and has endocrine disrupting properties with affects to human health and the environment. It is considered a priority substance for inclusion in the Annex XIV listing for these reasons and due to its high volume and wide range of applications.

Bisphenol A is one of the world’s highest production volume chemicals (1). It is widespread in the environment and has been detected in human blood, amniotic fluid, breast milk, fat tissue and the placenta (2). Urinary BPA has been detected in people from numerous countries, with most studies showing over 90% of individuals tested have BPA in their urine (e.g. 3) and several reporting higher levels in children compared to adults. It is used widely in food contact materials and is detected in both canned and fresh food. A recent study (4) found it was present in seafood from Europe, including mussels; where BPA concentrations increased considerably (46 fold) following cooking. If BPA were added to Annex XIV environmental concentrations and  levels found in humans would be expected to decrease relatively quickly, as BPA is not bioaccumulative or environmentally persistent.

Recently published studies continue to support further a potential link between BPA exposure and breast cancer risk (see reviews 5 and 6), especially if exposures occur during critical windows of development such as in utero. Numerous studies demonstrate BPA may exert damaging effects at low (environmentally relevant) dose exposures (e.g. CLARITY-BPA studies review, 7).

Breast Cancer UK would like to highlight our concern that bisphenols (e.g. BPS, BPAF, BPAP, BPF, BPB and BPZ), used as BPA substitutes in polycarbonate plastics, epoxy resins and thermal paper, have been shown to act as oestrogen mimics and may also increase breast cancer risk (e.g. 8; 9, 10). Some of these bisphenol substitutes are known to be widespread in the environment and in human populations (e.g. 11). We would urge ECHA to consider listing alternative bisphenols as part of a single group, based on BPA dossiers.

In summary Breast Cancer UK supports strongly BPA’s inclusion in the REACH authorisation list.

1. Galloway et al. 2018
2. Vandenberg et al. (2010). Environmental Health Perspectives 118(8): 1055-1070
3. Choi et al. (2017). International Journal of Hygiene and Environmental Health 220(2A): 282–298
4. Álvarez-Muñoz et al. (2018) Environment International 119: 570-581
5. Perrot-Applanat et al. (2018) Molecular and Cellular Endocrinology 475: 29-53
6. Wang et al (2016) Advanced Science (Weinheim) 4(2): 1600248
7. Prins et al. (2018) Basic Clinical Pharmacology and Toxicology 2018 Sep 12. doi: 10.1111/bcpt.13125 [Epub ahead of print]
8. Mesnage et al. (2017) Toxicological Sciences 158(2): 431-443
9. Ahsan et al. (2018) Chemosphere 197: 336-343
10. Chen et al. (2016) Environmental Science and Technology 50: 5438-5453
11. Lehmler et al. (2018) ACS Omega 3: 6523-6532
	A.2.02. Urge ECHA to consider regulating alternative bisphenols as a group based on BPA dossiers

Thank you for your opinion.	
				
3310
2018/12/03	Huntsman Advanced Materials (Europe) BVBA,
Company,
Belgium	Huntsman have provided in depth details multiple times to the 3 proposals to include bisphenol A in the candidate list. These comments, regrettably, were not taken into consideration. Huntsman however continues to provide comment and disagree with these prioritization processes for not being scientifically substantiated. Bisphenol A was made a political instrument strongly promoted by various media. The shocking result of this media and politically driven, rather than science based prioritization process, is that BPA has received the highest ranking among the substances of very high concern!
This greatly undermines the credibility of the substance prioritization process and a fair partnership between industry and authority. This also creates a very high level of uncertainty and is damaging for industry and society at large. In addition, this creates a very detrimental effect on the industrial activities and down-stream business.
	A.1.1.1. ECHA's obligation to recommend/prioritise substances on the Candidate List
A.1.1.2. Legal basis for prioritisation
A.1.1.3. Prioritisation approach applied
A.1.1.4. Information taken into consideration for the draft recommendation
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.8. Uncertainty as to whether authorisation will be granted	
				
3313
2018/12/04	ACEM (Motorcycle Industry in Europe),
Industry or trade association,
Belgium	See attachment	A.1.5.1. Potential other regulatory actions
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use
A.1.5.7. Potential competitive disadvantage
A.1.5.8. Uncertainty as to whether authorisation will be granted
A.2.07. Interpretation that use in hardeners for epoxy resins is intermediate use
B.2.01. LAD and the Sunset date should be set the maximum period of 24 months apart
C.2.01. Claim that a repair-as-produced clause for each substance listed on Annex XIV is necessary so that uses for legacy spare parts are exempted	
		Attachment: 3313_ACEM response to Public Consultation on BPA inclusion Annex XIV.pdf

3323
2018/12/05	PlasticsEurope ,
Industry or trade association,
Belgium	To facilitate the reading the comments pasted below including references and drawing are attached in part IV of this consultation.

1 Introduction and general comments

Epoxy resins have a unique combination of properties and performance characteristics. They are used in the manufacture of a huge number of components and end products where their presence is not always obvious. It is worth noting that at the point of contact with consumers, both epoxy resin content and potential for exposure to the chemicals used in their production is extremely low.
Europe is leading the world in this technology that has been invented and grown in Europe.
The Epoxy Resin Committee (ERC), a product committee of PlasticsEurope, the Association of Plastics Manufacturers in Europe, represents the interests of over 90% of Europe’s epoxy resins manufacturers.
BPA is mostly consumed in industrial settings as an intermediate (monomer) in the manufacturing of the most significant epoxy resin, BADGE, but as in limited volume as intermediate in the synthesis of hardeners.
ERC members manufactured a total of more than 250,000 tonnes of epoxy resin, in plants located in Germany, Spain, Netherlands, Czech Republic, Poland, and Switzerland.  Some 2,500 FTE employees are employed by these companies in Europe, which generated sales turnover of close to €1 billion. Epoxy Manufacturers invest as well more than €15 million in Research & Development activities, which include university collaborations.
The socio-economic value (and linked employment levels) of downstream industries that depend on the enabling characteristics of epoxy resins are many times these values.  The 2015 figures  have been introduced in the Commission Consultation  run in parallel to this specific consultation
Bisphenol-A (BPA) has been identified as substance of very high concern (SVHC) in 2017/2018 for its Toxicity for reproduction (Article 57c), Endocrine disrupting properties (Article 57(f) – environment) and Endocrine disrupting properties (Article 57(f) – human health).
Among the substances proposed for inclusion in the 9th recommendation (prioritisation) BPA is listed with a score of 29, based on: 1. Its inherent properties as ED under Article 57(f), the volume identified as being in scope of authorization (1000 – 10000mt/y) and its use in industrial and professional uses.
BPA is likely the most studied industrial chemical substance in use. Its hazards are well characterized by valid guideline studies which enable reliable risk assessments of its uses. BPA registrants have provided and updated a comprehensive REACH dossier discussing the hazards and defining safe exposure scenarios for safe uses. Uses, for which the available information was insufficient to support safe use by the registrants have been removed from the dossier in the most recent update in December 2015.
Industry (BPA REACH consortium and Plastics Europe) does not agree with the identification as substance of very high concern and have challenged those decisions in front of the European Court of Justice. The court proceedings are still ongoing and will foreseeably not conclude before sometime in the second half of 2019. Prioritisation at this stage, before the European Court of Justice (ECJ) has decided on the legitimacy of the SVHC identification on three different counts, would be of a preliminary nature.
The SVHC identifications have been based on studies which have been excluded from hazard assessment for their lack of scientific rigor and reproducibility by relevant competent authorities. Other, relevant studies have been disregarded in the identification review. The registrants strongly disagree with the conclusion that BPA elicits hazards at relevant exposures, based on its weak endocrine activity, which is a requirement for the identification as an endocrine disruptor for human health and the environment. Endocrine activity is observed only at high concentrations far above foreseeable exposure levels. This position has been expressed and documented in details previously (see Input to Risk Management option Analysis RMOA/ Conclusion Document) .
The Epoxy Resin Committee considers the arguments of their registrants as valid and is concerned about the potential regulatory implications (which in turn are derived from the SVHC identifications) on the uses of its members. The ERC also takes the position that the quoted reasons for the authorisation proposal are based on weak scientific arguments. Pursuing such unnecessary regulatory actions is in the view of the ERC members putting the economic success of the European epoxy resin industry, a global technology leader in its areas, at risk.

Uses in Scope
According to the Prioritisation supporting document only certain uses are in scope of the authorisation. Specifically for the use as intermediate (e.g. in the manufacturing of BADGE or polycarbonate) the document states that these “appear not to be in the scope of authorisation”.
ERC members concur that. “in line with REACH  , uses as intermediates are excluded from authorisation and therefore uses such as the manufacture of polycarbonate, epoxy resins, coating materials, substances or polymers are not considered in the scope for authorisation in this document.”
Annex I of the draft background document gives the following on uses in scope of the authorisation: “Uses of bisphenol A that appear to be in the scope of authorisation are the formulation and use of epoxy resin hardeners (…)The corresponding volume in the scope of authorisation is estimated to be in the range of 1,000 - 10,000 t/y.”

The ERC would like to point out that the document miss-represents the nature of epoxy hardeners: A wide variety of substances are used as hardeners. Only a small fraction of these hardeners is built on the use of BPA, whilst the vast majority of hardeners is of a different chemical nature. More importantly in the context of the identification: The description of the manufacturing and formulation of hardeners building on BPA in the registration dossier may be misunderstood. Only hardeners that are manufactured by formulating BPA with other components would seem to fall in scope of an authorisation (<500mt, number of sites 1-10).
As becomes obvious from the registration dossier, and more obvious based on the above considerations, the uses in scope target a small number of mainly industrial uses. Those however, are the fundament for technically advanced, high performance products: Products such as wind rotor blades, for which high strength structural composites are required; or coatings for pipelines and water boilers, for which strong corrosion protection is required; or fast curing chemical anchors at construction sites, which are required to quickly fix steel constructions with other construction elements like concrete and protecting the steel against corrosion ,thus ensuring a  long service life of the construction.

The hardener, also such containing BPA, upon reaction with the epoxy resin are transformed and become an integral part of a highly crosslinked, three-dimensional polymer matrix. These polymers constitute articles. The bulk of the residual free BPA in the Epoxy Hardener is reacted away, very small remaining amounts are contained in a rigid, highly crosslinked polymer matrix. The final epoxy resin does not release BPA at any level which would be considered relevant for authorization.

Taking the volume of the uses in scope of 1000 – 10’000mt/y as presented in the registration dossiers, i.e. not discriminating formulated hardeners and new substances, it is important to highlight that this reflects only a small fraction of the total uses (in the range < 1%) of BPA. The actual volumes reported in the current CSR (2015) per site are in the lower thousands of mt (2000-3000mt). Breaking this down to actual uses, this is:

Formulation of epoxy resin hardeners (industrial)   <500mt
Use of Epoxy Hardeners (industrial)                            <2000mt
Use of Epoxy Hardeners (professional)                       <600mt

Concerns for BPA
BPA has been subject to several regulatory processes under REACH, SVHC identification, CoRap Substance Evaluation and Restriction. Concerns on exposure/emissions raised in the related Annex XV dossiers, Substance evaluation report, RMOA conclusion document and supporting document for prioritisation all were around 2 major matters of concern:

a. Consumer/ general public exposure to BPA
b. Background trace concentrations of BPA in the environment, mainly surface water
Concerning consumer exposure to articles unfortunately, the stipulated concern for consumer uses of large epoxy articles is poorly documented in the Substance Evaluation document.  During a Follow-up with the Competent Authority (German BfR) the identification of possible errors have been reported but with so far no known follow up.
This seems to support the conclusion of the comprehensive assessment by EFSA (2015)  that “BPA poses no health risk to consumers at the current level of exposure.”
Despite this reported absence of risk and to encounter potential uncertainties, BPA consumer exposure has recently seen a further tightening of safe threshold values in food, toys and potentially drinking water (ongoing regulatory process).
Today’s consumer exposure to BPA is more likely to originate from the still permitted use of BPA in thermal paper, the use of recycled paper (generated from a mixed feed of thermal and regular paper), or other uses of BPA such as the use as an antioxidant and stabilizer in PVC compounding or residuals BPA levels in recycled PVC. The use of thermal paper will be restricted as of 2020, the use of BPA in PVC is not in scope of authorisation, as correctly stated by ECHA, due to its removal from the lead registrant’s dossier.
In the SEV conclusion document  from Germany it is stated that emissions to the environment might have been underestimated in the calculation of the risk assessment. The calculated PNEC values have been questioned by citing other none guideline studies and pointing to exploratory studies showing low dose response effects in some aquatic species. The validity of these cited studies has been challenged by industry and discussed with the rapporteur. One example is the underestimated emissions from sewage water treatment plants due to the widespread occurrence of BPA in toilet paper.
This emission is soon going to disappear as it results from the thermal paper content in recycled paper. Nevertheless, before evaluating whether further regulation is needed to regulate BPA, the impact of the BPA thermal paper restriction on environmental emissions is not awaited and nor taken into consideration.

The current concentrations of BPA in surface water are expected to drop significantly as a result of the thermal paper restriction.

In other studies, provided by the PC/BPA group under the umbrella of PlasticsEurope it has been shown, that during their service life and disposal articles made of Epoxy resins and polycarbonate contribute less than 1% to the total BPA emissions to surface water (results for Germany)
Relevant BPA uses have been risk assessed in the REACH dossier and found to have low RCR’s (risk characterization ratios) regarding the DNEL’s and PNEC’s applied, which demonstrate safe use of the substance. Exposure to air is negligible due to its very low vapour pressure and dermal exposure can be prevented by appropriate personal protective equipment (PPE), emission to water is also very low.
The uses in scope (industrial use and formulation of epoxy hardeners and professional use) also suggest a concern for worker exposure, which has not been expressed in the above mentioned REACH related process documents. The REACH dossier includes an assessment of worker exposure (inhalation, oral, dermal) to BPA via theses uses. As DNEL the recently published SCOEL value (SCOEL 2014) of 2mg/m3 was used. Safe use could be demonstrated with RCR’s below 0.1.
Concerning inherent properties REACH Article 58(3) states that priority should be given to substances with PBT and vPvB properties.
BPA is not classified as a PBT or vPvB substance. It does neither fulfil the screening criteria nor the definite criteria of persistence or of bioaccumulation or of toxicity. It is readily biodegradable (see REACH registrants lead dossier). BPA is being degraded up to 80% in a 28 days period according to several studies as cited in the REACH dossier. PBT criteria have been prioritisation criteria due to concerns for an irreversible build up in the environment and resulting exposure from bioaccumulation. However, current measured levels of BPA are well below the safe exposure levels derived in line with guidance for risk assessment. BPA should not be prioritised for this aspect.

Conclusions why BPA should not be prioritized for Authorisation

Authorisation and the proposed prioritisation of BPA for Authorization is an unnecessary and disproportionate measure as it

1. Impacts uses that have not been identified as ‘of risk’ for workers in the substance evaluation
2. Does not reduce any exposure to consumers/ the general public as the specific uses in scope and articles thereof are not consumer related
3. Does not contribute to the reduction of BPA in the environment as epoxy products do not significantly contribute to environmental emissions of BPA.
4. BPA does not fulfil the criterion PBT for priority setting as listed in Article 53(3).

The taking into scope of the one specific use of BPA containing Epoxy hardeners means sacrificing a low number of specific technology uses and substituting these specific epoxy hardeners with potentially less studied products. This regulatory step does not provide additional benefit to society or the environment.
It must also be pointed out that a possible authorisation for BPA will affect the use of BPA in some hardeners for the European producers only! This will provide an advantage to non-European producers and might force users of BPA containing hardeners to produce outside the EU. The final Epoxy product does not contain BPA at any current regulatory relevant level.

2 Information on Use in Scope: Epoxy Hardeners (BPA containing)
Besides referring to the SVHC classifications the background document states in Annex I: “Bisphenol A is ubiquitously and regularly found in all environmental compartments indicating continuous emissions of the substance which, however, cannot be traced back to single uses (RMOA, 2017)”.
The use in scope of authorisation is an industrial, and to a small part, a professional use (professional use as stated in the CSR <1000mt).  This is not a use where the substance BPA could end up in the environment or in consumer articles with any significant release potential. If any of the articles made from or coated by epoxy products for which BPA containing hardeners have been used, any potential release can be regarded as negligible. Epoxy products are thermoset polymers with a 3-dimentional highly crosslinked polymer network. Hence these specific epoxy articles are most likely not the sources for a continuous emission into the environment.
The Background document for Prioritisation states:
“Uses of bisphenol A that appear to be in the scope of authorisation are the formulation and use of epoxy resin hardeners, both at industrial sites and by professional workers, which correspond to less than 1% of the total tonnage. The corresponding volume in the scope of authorisation is estimated to be in the range of 1,000 - 10,000 t/y (see Section 2.2).”
The background document states in Annex I:
“Bisphenol A is ubiquitously and regularly found in all environmental compartments indicating continuous emissions of the substance which, however, cannot be traced back to single uses (RMOA, 2017)”.
The prohibition of the use as epoxy hardener will not help resolving or improving the above mentioned issue.

 
3 Production and use Epoxy Products

The Epoxy production is a 2-step process.
(1) Step 1: Epoxy resin production (BPA use as intermediate)

(2) Step 2: Epoxy Resin/Hardener Curing
As a next step Epoxy resins are mostly cured with BPA-free hardeners. However, for special coating uses, epoxy resins are polymerised with hardeners containing a few per cent of free BPA. These hardeners are often further formulated. Fillers, solvents and pigments are mostly added, which further reduce the ratio of residual BPA in the hardener before the actual final curing step. The BPA content is usually needed to accelerate curing if fast curing is needed (no post-curing process).

Upon cure the residual ratio of unreacted bisphenol-A in epoxy/hardener thermosets is mostly decreased by several orders of magnitude, since it reacts with the epoxy resin.
Residual –unreacted- Bisphenol A is firmly trapped in a 3-dimensional thermoset polymeric network, with glass transition temperature above 70°C, depending on the system up to 90°C. That means that there is no molecular mobility at room temperature or at elevated temperature, i.e. up to 70°C.  Therefore, the availability of Bisphenol-A, e.g. via exudation, leaching or extraction is estimated far below the ppm level theoretically available.

Table 1. Product classes – types of epoxy/hardener combinations with BPA containing Epoxy Hardeners and applications
Technology area Product classes Application / process
1 Phenolic hardeners (BPA produced with stoichiometric excess of  BPA) Industrial functional metal coating for heavy duty, e.g. coating of oil pipes,  concrete reinforcing bars, appliances, radiators etc.  Industrial formulation via extrusion and grinding. Industrial electrostatic spraying and curing (Powder Coating, high Temp)
2 Composites
(Majority BPA-free hardeners, ongoing  substitution to BPA free, BPA formulated) Wind energy, e.g. wind mill rotor blades, housing (nacelle), Pipe rehabilitation Industrial processes:
Prepreging
Vacuum Infusion
Filament winding/impregnation
Resin Transfer Moulding (RTM)
3 Liquid composite/BPA formulated Chemical anchors Industrial & professional:
Liquid fast cure

Phenolic hardeners (Industrial Use)
For Epoxy Products a wide variety of substances, which do not contain free BPA, such as amines, amine adducts (Liquid Epoxy Resins /amine reaction products) and Mannich bases or anhydrides, are used.

Some specialized hardeners (e.g. phenolic hardeners) are reaction products of epoxy resins with an excess of BPA and hence other REACH substances. This excess BPA remains in the hardener until consumed during the curing reaction with resins. These hardeners are only used for industrial applications.

Phenolic hardeners are used for functional powder coatings, where corrosion resistance is of major importance to the final product (such as pipes for pipelines, coating (primer) of metal support structures, e.g. bridge pillars etc.). This type of hardener provides the required long lasting corrosion resistance combined with other physical properties such as elongation, hardness, etc.

Formulated Epoxy hardeners (Industrial and Professional)
Formulated amine hardeners are manufactured with a few per cent of deliberately added BPA. Upon cure with an epoxy resin, the BPA component mainly reacts with the epoxy resin, whilst a small part of BPA remains locked in the resulting 3D polymer network.
It is important to note that the applications of such formulations are mostly performed by industrial companies, and to a lesser extent by professionals (construction), all with a high degree of engineering controls and containment to prevent a potential release to the environment.
Some especially sensitive areas with strict non-use policies may have already reduced their consumption of such hardeners, whilst other areas with extensive and long qualification schemes may not be able to do so without disrupting their business.

Composites
The vast majority of composites today is produced without BPA containing Epoxy hardeners.
BPA is currently still used in a few core applications. One of the main uses are composites for rotor blades of windmills. Wind blade manufacturing is an industrial use (vacuum infusion).
Pipe rehabilitation is a professional use. The BPA containing hardeners are used for rehabilitation of predominantly waste water pipes. The impregnated glass fibre liner used for the pipe repair is shielded from direct water contact by an inner liner made from PE/PP.

Chemical Anchors
Chemical anchors are based on two components highly reactive adhesive systems based on a formulated epoxy resin and a BPA-containing hardener. A premixed blend of the 2 components is injected into a borehole prior to the insertion of a steel stud or bolt, which is used as a support point for e.g. steel structures like brackets. The brackets in turn may carry pipelines or cable routes. Due to the high reactivity of the system, the studs or bolts are fixed into their final position quickly and the system can be loaded with support structures early on.

4 Release from industrial sites to the environment upon manufacture, formulation and application of BPA containing epoxy hardeners

The release of BPA during the manufacturing, formulating and applying BPA containing Epoxy hardeners can be considered as very low as demonstrated by the risk assessment of these uses in the REACH dossier (see exposure scenarios 9.13, 9.14 .9.15).  BPA used for manufacturing/formulating of hardeners is usual applied in a solid form to be reacted or dissolved.
Soil surfaces
As the production of BPA containing hardeners is taken place in an industrial setting all relevant surfaces are usually sealed to prevent emission to soil.

Water
The industrial formulation of epoxy resin hardeners is a dry process and no waste water is generated, hence there is no release of BPA to waste water.

Air
Waste air has to be treated by filtration or incineration with efficiencies of at least 95%. A scrubber is usually used to treat exhaust air containing BPA dust.
Measurements at an industrial site during spray application of liquid two components epoxy systems containing BPA-based hardener have demonstrated that concentrations of BPA in aerosol and vapour, both in immediate proximity of the applicator as well as adjacent areas, are extremely low and well below the occupational exposure limit by orders of magnitude.
5 Release from professional uses to the environment by applying BPA containing epoxy hardeners

The release of BPA during the application of BPA containing Epoxy hardeners on a professional scale can be considered as very low as demonstrated by the risk assessment of these uses in the REACH dossier (see exposure scenario 9.16) This use only covers a very small fraction of Epoxy hardener uses, the total EU tonnage is only 540 t/year.
The hardeners containing BPA at professional sites are either applied as part of a liquid blend with resins or as part of a solid mixture. The only relevant emissions to the environment from this use is the emission to air as the process is a dry process and no waste water is generated. Based on the conditions and measures described in the preceding paragraphs, the emissions of Bisphenol A to the environment is adequately controlled.

Soil surfaces
As the above described is usual a dry process, emissions to soil are minimal

Water
The industrial formulation of epoxy resin hardeners is a dry process and no waste water is generated, hence there is not release of BPA to waste water.

Air
Due to low amounts of solid hardener used in professional settings, emission to air is considered low and well below any PNEC as provided in the REACH registration dossier.

6 Summary and Outlook
It is recognized by the authors that BPA use as additive such as in thermal paper or PVC, where there’s a high potential for release to the environment, have to be phased out and substituted.
However these additive applications with release potential are not targeted with the regulatory tool of inclusion into Annex XIV and authorisation. Instead high performance Epoxy applications such as the production of functional coatings, or composites for wind energy rotor blades, which is adequately risk controlled by a responsible industry and doesn’t pose a high risk to release BPA to the environment, is in the focus of regulatory authorisation efforts. The high performance epoxy products in these very specific market segments are difficult to substitute, which is already obvious by the fact that customers are willing to pay premiums for their superior performance versus alternatives.

Still there is substitution going on for some of these applications, which in large part is the result of business reduction or disruption due the regulatory uncertainty around BPA created along the value chain with respect to the future of this critical substance. This could also impact high end uses in the aircraft and automotive industry. Alternative substances are not necessarily safer and certainly not “non-hazardous” as a certain reactivity of the substance is needed in order to achieve the desired reactivity profile of a 2-component system. Higher reactivity potential is quite commonly paired with a certain hazard potential. Hence technical substitutes may as well be exposed to regulatory scrutiny and pressure and may not constitute safer and well tested alternatives after all.

Phase-out scenarios are difficult to determine as these depend usually on qualification timelines for certain parts, which could take up to several years.

	A.1.1.2. Legal basis for prioritisation
A.1.1.3. Prioritisation approach applied
A.1.1.4. Information taken into consideration for the draft recommendation
A.1.1.5. New information and next steps towards the final recommendation
A.1.2.1. Volume in the scope of authorisation
A.1.5.1. Potential other regulatory actions
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use
A.1.5.7. Potential competitive disadvantage
A.1.5.8. Uncertainty as to whether authorisation will be granted
A.2.03. Claim that prioritisation would be preliminary as the European Court of Justice has not yet decided on challenged SVHC identification
A.2.07. Interpretation that use in hardeners for epoxy resins is intermediate use	
		Attachment: 3323_ERC_PlasticsEurope_BPA Public Consultation for Authorisation_05_12_2018.pdf
		
3325
2018/12/05	ADS Group Limited,
Industry or trade association,
United Kingdom	Bis-Phenol A (CAS no. 80-05-7, EC no. 210-245-8).

BPA is used in the production of many polymeric products used in the Aerospace and Defence industry however perhaps the two most well known are in the manufacture of Epoxy resins and Polycarbonate.

1- Epoxy compounds manufactured from Bisphenol A are primarily Bisphenol A diglycidyl ether (BADGE - CAS n° 1675-54-3) and the pre-polymerised product Bisphenol A epichlorohydrin polymer (CAS n° 25068-38-6) are vital for a large range of applications, including but not limited to:
• Epoxy resins for composite materials subsequently used for structural components (weight reduction and CO2 emission saving),
• Epoxy Adhesives for modern manufacturing techniques,
• Epoxy Paints and varnishes for product durability.
• Epoxy resins as potting compounds for the majority of electrical components used on printed circuit boards

2- Intermediate use to manufacture polycarbonate, a highly valued construction material for windows and other transparent objects with excellent properties for these to function in the harsh environment like high altitudes or combat situations. Parts produced out of polycarbonate include:
a. Windows for Aeroplanes and other aircraft
b. Covers for navigation, anti-collision lights, etc.
c. Personal protection equipment for civil and military usage (goggles, visors of helmets)
d. Electrical insulation
e. Modern communication with optical technology

An additional usage of BPA is as a direct addition to a variety of hardeners. Here once mixed with the epoxy polymer outlined above, the monomer effectively ceases to exist.
	Thank you for the information provided	
				
3331
2018/12/05	ChemSec,
International NGO,
Sweden	ChemSec supports the prioritisation of BPA for inclusion in Annex XIV	Thank you for your opinion.	
				
3352
2018/12/05	PlasticsEurope,
Industry or trade association,
Belgium	The respondent comprises the PlasticsEurope PC/BPA Group, whose members are the leading BPA and polycarbonate producers and major BPA users in Europe. The group shares the societal concern to protect both human health and environment. Nevertheless, it should be mentioned that PlasticsEurope has filed cases for annulment for all three SVHC identifications as it strongly disagrees with the Candidate Listing of BPA as the first step into authorisation. Although it disagrees with the rationale that has led to the Candidate Listing it wants to make a constructive contribution.
From the ECHA background document it is apparent that there is a single type of application that is being targeted for authorisation: formulation of epoxy resin hardeners at industrial sites and use of epoxy resin hardeners at industrial site and by professional workers. The background document further states that a basis of the concern is the possible emission to the environment of BPA. The document fails to make clear whether this emission is caused through the uses subject to authorisation but it is a logical implication. Aiming authorisation at one single, mainly industrial use does not contribute significantly to further protection of the environment nor human health.
The respondent would like to confirm the following:
- BPA is used as an intermediate – and therefore out of scope of authorisation -  in the manufacturing process of:
o Polycarbonates (formulation and production both occur on site and are exempt from authorisation)
o Epoxy resins

o Formulation BPA uses as per the joint CSR are out of scope of authorisation except for the formulation of epoxy resin hardeners.
The respondent also wants to inform the European Chemicals Agency that:
- The respondent has evidence – see response to section IV – that the background level of BPA in the environment (which is the compartment the authorities say is at potential risk) is not related to the uses in the joint registration dossier;
- In addition, the use of Epoxy resin hardeners represents only a small fraction of this already very low background level from Epoxy products and polycarbonates
- The majority of the use of epoxy hardener is at industrial sites under stringent risk management measures
- Germany has stated in its RMOA that it proposes to restrict some to be defined uses of BPA with the aim to lower the releases of BPA into the environment;
- ECHA has correctly indicated that the use of BPA in thermal paper – which is likely a large source for environmental emission – will be restricted by 2020 (“Shall not be placed on the market in thermal paper in a concentration equal to or greater than 0,02 % by weight after 2 January 2020”). However, with a fast inclusion of BPA into Annex XIV, the effect of this restriction on BPA background level is not taken into account
- The recommendation for inclusion makes mention of other uses (e.g.: PVC stabiliser) but these uses are neither supported in the joint registration dossier nor – to the knowledge of the respondent – covered by a downstream user dossier.
As it stands there are several regulatory measures that already now or will soon apply to BPA that are likely to have considerable impact. These include the recent EU-wide reduction of the migration limit in food contact materials and the broadening of its applicability to coatings and varnishes, the lowered migration limit for infant toys in EU, the new EU indicative occupational exposure limit value (IOELV) and the proposed reclassification combined with possible restrictions envisaged by Germany. Furthermore (see appendix below) there are a lot of regulatory measures already applicable to BPA at national or international level.
The aim of authorisation should be to minimise exposure of humans and the minimisation of exposures in the environment itself. In light of the above the respondent is of the opinion that prioritisation of BPA for authorisation does not serve a useful regulatory purpose.
- Authorisation as regulatory measure for BPA exposure does not add to the aim of protecting the environment.
- Comprehensive regulatory measures have already recently been put in place or are in progress to be implemented
- The impact of the recent restriction (thermal paper) is not considered
- The measure is disproportionate because it partially relies for its justification on uses not covered by the joint registration dossier nor (to our knowledge) in other registration dossiers.
As ECHA will be able to find in the response to section IV, the respondents are in the process of establishing where BPA is released into the environment. Details of this study now in its third iteration are given below. The results do not – for the moment – give any indication that the proposed authorisation affecting epoxy resins would successfully tackle the source of BPA in the environment.
Furthermore, the respondent expects that the single use that would be the target is partly substituted where technically feasible due to the already ongoing regulatory pressure on BPA. The remaining use of BPA in Epoxy resins targets a small number of high performance technically advanced applications with little risk of emission to the environment.
It is entirely possible that by the time authorisation becomes effective there would not be any relevant registered uses within the scope of authorisation and it is a certainty that could happen briefly thereafter. The epoxy hardener uses are likely to be substituted sacrificing technical performance. The substitutes might well involve materials with other hazards affecting the environment and humans and lead to regrettable substitution. There is therefore no added value to placing BPA on the authorisation annex and it should be avoided to focus instead on tackling the actual sources of emission into the environment.
	A.1.1.1. ECHA's obligation to recommend/prioritise substances on the Candidate List
A.1.1.2. Legal basis for prioritisation
A.1.1.3. Prioritisation approach applied
A.1.5.1. Potential other regulatory actions
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.4. Control of risks	
		Attachment: 3352_Attachement to PlasticsEurope Responses to public consultation on BPA prioritisation_5 december 2018.pdf
		
3353
2018/12/05	Norway,
Member State	The Norwegian CA supports the prioritisation of Bisphenol A for inclusion in Annex XIV according to Article 57 (c) and 57 (f) for human health and the environment. We consider the prioritisation criteria to be fulfilled.
The endocrine disrupting properties of Bisphenol A are especially of concern considering the detections in biological samples, such as bird eggs and blood, as well as in indoor dust and human biomonitoring. A newly published study from a collaborative project across six established population-based birth cohort studies in Europe shows wide exposure of both pregnant mothers and children to bisphenol A: https://www.sciencedirect.com/science/article/pii/S016041201831225X. Furthermore, environmental monitoring confirms that the substance is present in most matrixes (freshwater, marine water, soil, biota, sediment, sewage sludge, air/dust), even though the substance is not considered to be highly resistant to degradation. This underscores that releases to the environment are continuous and widespread, and that exposure to the environment is of concern for this endocrine disrupting substance.
	Thank you for your opinion.	
				
3388
2018/12/05	CHEM Trust,
National NGO,
United Kingdom	CT strongly supports the prioritisation of BPA for inclusion in Annex XIV.

Even if the intermediate uses of BPA (and thus the main uses) are outside the scope of authorisation, the volume of the remaining uses is still very large and significant (estimated to be between 1000 and 10 000 t/a). BPA can be detected in nearly every human being and is found ubiquitously in all environmental media. Emissions are mainly from diffuse sources and often of unknown origin (see Substance evaluation dossier by Germany and Fischer et al. 2014 (Fischer, Benedikt, Milos Milunov, Yvonne Floredo, Peter Hofbauer and Anke Joas: Identification of relevant emission pathways to the environment and quantification of environmental exposure for Bisphenol A; Texte 41/2014, Umweltbundesamt ). It is therefore very relevant to include BPA in Annex XIV so that uses can only be continued in case of well-justified reasons, i.e. if socio-economic benefits outweigh the risks and if there are no safer alternatives available. Given that in our view it is not possible to set a safe threshold for BPA with sufficient certainty we consider that any potential future authorisation will have to be considered using the socio-economic route to authorisation (see also outcome of REACH Review on the scope of article 60.3 https://ec.europa.eu/transparency/regdoc/rep/1/2016/EN/COM-2016-814-F1-EN-MAIN-PART-1.PDF).
In addition, as the main uses are outside the scope of authorisation, there is a need to follow up and assess whether further restrictions for BPA as well as similarly acting bisphenols are necessary(see also below).
	A.2.06. Need to assess whether further restrictions of uses outside the scope of authorisation are necessary

Thank you for your opinion.	
				
3395
2018/12/05	Aerospace Industries Association (AIA),
Industry or trade association,
United States	A key issue for BPA is that the vast majority (but not all) of this use is understood to be classified as an intermediate and will therefore be outside the scope of Authorisation.  AIA notes that as much as 99% of BPA use can be classified as intermediate [ECHA Draft background document for BPA, Annex I].  The intermediate uses include the manufacture of polycarbonates, epoxy resins such as BADGE or DGEBA, other resins and polymers, coatings, adhesives and potting compounds.  Downstream non-intermediate uses in the aerospace sector are numerous, but also extremely low in volume compared with other industry sectors.  The difficulty for the aerospace sector lies in differentiating between intermediate uses and not, and whether or not a SDS for a formulation intended for end use will actually contain BPA once cured.

Despite significant messaging by upstream actors in the BPA supply chain there is a persistent lack of clarity in the industry regarding intermediate and end uses of BPA.  A number of factors contribute to this situation:
• SDSs are unclear - BPA formulations have a global supply chain with many actors responsible for authoring SDSs.  Many of these actors may not make the most accurate substance identification choices.  In many cases multiple CAS numbers can be used to identify the same substance.  In addition, the naming conventions for resins have not been standardized.  Some of the CAS numbers for resins suggest the presence of unreacted mixtures of chemicals containing BPA and epichlorohydrin.
• Unreacted BPA – The aerospace and defense sector OEM end users in the aerospace sector understand that residual unreacted BPA that is present in resins below 0.1% is not subject to authorisation (intermediate use).  Major resin producers have indicated that BPA is in fact present in their resins at concentrations well below 100 ppm (<0.01%).  However, the aerospace sector OEMs also understand that some of the BPA CAS numbers are also used for partially reacted resins where the BPA concentration is greater than 0.1%.
• Intentionally added BPA - Formulators sometimes add BPA to formulations with a curing agent to increase crosslinking.  In this role the BPA acts as a cure accelerator (hardener) and is typically incorporated into the cured polymer network.  It is not always clear to OEMs when this is done or at what level the (unreacted) BPA is present in the final formulation. BPA can also be used to help with incorporation of some toughening materials such as rubbers into epoxy adhesives, composites.  In this case the BPA is pre-reacted with the rubber prior to being incorporated into the final product form.  The completion of that reaction is unknown.  Similar to the curative approach, the unreacted BPA should incorporate into the final cured polymer network.

Should ECHA and the EC decide to proceed with adding BPA to Annex XIV requiring Authorisation, the supply chain complexity and numerous formulations, applications and uses of BPA, will require extensive and time-consuming coordination with the many actors in the aerospace and defense supply chain.  We reiterate that the highly specialized uses of these numerous, relatively low volume formulations, are unique to the aerospace and defense sector.   This will require a significant effort for both the industry and ECHA to execute the Autorisation Application process.
	A.2.08. Unclarity as to whether uses are within or outside the scope of authorisation
A.2.09. Uncertainty as to whether only uses of BPA as such fall under the authorisation requirement or also uses of epoxy resins based on BPA as monomer
B.1.2.1. Extensive time needed in the supply chain to get organised for preparing application (e.g. due to high number of users)
B.2.01. LAD and the Sunset date should be set the maximum period of 24 months apart	
				
3405
2018/12/05	AeroSpace and Defence Industries Association of Europe (ASD),
Industry or trade association,
Belgium		A.1.5.1. Potential other regulatory actions
A.2.07. Interpretation that use in hardeners for epoxy resins is intermediate use
B.1.2.1. Extensive time needed in the supply chain to get organised for preparing application (e.g. due to high number of users)
B.2.01. LAD and the Sunset date should be set the maximum period of 24 months apart	
		Attachment: 3405_ASD input_on_BPA.pdf
		
3422
2018/12/06	European Automobile Manufacturers Association - ACEA,
Industry or trade association,
Belgium	see attachment	A.1.5.1. Potential other regulatory actions
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use
A.1.5.7. Potential competitive disadvantage
A.1.5.8. Uncertainty as to whether authorisation will be granted
A.2.07. Interpretation that use in hardeners for epoxy resins is intermediate use
B.2.01. LAD and the Sunset date should be set the maximum period of 24 months apart
C.2.01. Claim that a repair-as-produced clause for each substance listed on Annex XIV is necessary so that uses for legacy spare parts are exempted	
		Attachment: 3422_20181205_ACEA_BPA.pdf

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3299
2018/11/29	Breast Cancer UK,
National NGO,
United Kingdom	As BPA is not bioaccumulative or environmentally persistent, adding it to Annex XIV would likely result in a relatively rapid reduction in human exposure. In order to expedite this, Breast Cancer UK would urge ECHA to adopt the shortest possible latest application slot (i.e. 18 months after inclusion of a substance on the Authorisation list). We welcome ECHA’s decision not to propose exemptions for uses of BPA on the basis of Article 58(2) or product and process orientated research and development (PPORD).	Thank you for your opinion.	
				
3310
2018/12/03	Huntsman Advanced Materials (Europe) BVBA,
Company,
Belgium	The debate on the proposed LAD is superfluous. The uncertainty created around this substance is already leading to a strong decrease of activity in the EU, with expected potential disruption and to a migration outside of the REACH area.	B.2.01. LAD and the Sunset date should be set the maximum period of 24 months apart

Please see references to responses in section I	
				
3313
2018/12/04	ACEM (Motorcycle Industry in Europe),
Industry or trade association,
Belgium	N.A.	Please see references to responses in section I	
		See the corresponding embedded attachment in table 1 of Part I: 3313_ACEM response to Public Consultation on BPA inclusion Annex XIV.pdf		
3323
2018/12/05	PlasticsEurope ,
Industry or trade association,
Belgium	
Transitional Arrangements General
Use of BPA-containing hardeners for the production of spare parts in critical industry segments such as aerospace or automotive should be exempted from authorization obligations for a to-be-specified time period. That timeframe would be determined by the model life cycle and the obligations (regarding supply security) which have been imposed on suppliers by OEMs.
Hardeners containing BPA as an additive are in many cases products that have been on the market for many years and are used in critical areas where they had to go through a long qualification process. Spare parts made from these products need to be available for an extended time (sometimes decades due to model life cycle). Replacement parts for currently operating airplanes could serve as an example. Re-formulated products must not be used as an alternative in these cases as their compatibility cannot be fully ensured. A resulting potential decrease in the safety level (product failure) of currently operating vehicles is not acceptable. In addition, significant qualification times, for instance up to 10 years (not including any development of replacements) in the aerospace sector, have to be taken into account.

Supply Chain Information: BPA Epoxy Hardener
BPA containing hardeners for specific composites such as for wind rotor blades, or composites for transport are usually formulated by the epoxy systems producer or a specific formulator and is supplied directly or via distribution to the article manufacturer, who then supplies the final article (for ex. Rotor blades, automotive composites). For pipe rehabilitation a solution integrator, a company in possession of the technology provides the purchased epoxy system to applicators, carrying out the pipe repair. Hence actors in the supply chain are up to 4.

	B.1.2.1. Extensive time needed in the supply chain to get organised for preparing application (e.g. due to high number of users)
B.1.2.2. Lack of alternatives, socio-economic aspects
B.2.01. LAD and the Sunset date should be set the maximum period of 24 months apart
C.2.01. Claim that a repair-as-produced clause for each substance listed on Annex XIV is necessary so that uses for legacy spare parts are exempted	
		See the corresponding embedded attachment in table 1 of Part I: 3323_ERC_PlasticsEurope_BPA Public Consultation for Authorisation_05_12_2018.pdf		
3325
2018/12/05	ADS Group Limited,
Industry or trade association,
United Kingdom	In all cases outlined in the section above the time taken to validate alternatives, assuming that such products currently exist, would be expected to exceed the proposed sunset date given in the draft background document published on the 5th September 2018. The lengthy and complex transitions to establish satisfactory confidence in any alternatives are well established (An elaboration of key aspects of the authorisation process in the context of aviation industry. April 2015).

Removal of such products from the supply chain would have a seriously negative impact on the Aerospace and Defence sectors, affecting both the repair of existing and the building of new products.
	B.1.2.2. Lack of alternatives, socio-economic aspects

B.2.01. LAD and the Sunset date should be set the maximum period of 24 months apart	
				
3352
2018/12/05	PlasticsEurope,
Industry or trade association,
Belgium	The respondent notes that ECHA recommends a separation between LAD and Sunset date of 18 months. In the light of the response under I. the respondent opposes the inclusion for authorisation at all, however insofar as inclusion would take place, the respondent suggests that both the LAD and the Sunset date should be set the maximum period of 24 months apart.
The respondent strongly believes that authorisation is not the appropriate tool to minimise emission/exposure of BPA. The, more appropriate, substitution in technologically advanced industrial uses of BPA containing epoxy resin hardeners would require further research and longer process times. As regards the possibility of new registrants – the respondent deems it unlikely that anyone would draft a new registration dossier for BPA under the current circumstances. The uses accounting for the largest volumes are all intermediate and therefore out of scope of authorisation based on art. 2.8 REACH.
	A.1.5.1. Potential other regulatory actions

B.1.2.1. Extensive time needed in the supply chain to get organised for preparing application (e.g. due to high number of users)

B.1.2.2. Lack of alternatives, socio-economic aspects	
		See the corresponding embedded attachment in table 1 of Part I: 
3352_Attachement to PlasticsEurope Responses to public consultation on BPA prioritisation_5 december 2018.pdf		
3353
2018/12/05	Norway,
Member State	In general, we are in favour of a short LAD slot.	B.1.1.3. ECHA's proposal for latest application dates

Thank you for your opinion.	
				
3388
2018/12/05	CHEM Trust,
National NGO,
United Kingdom	The years of debate on BPA`s hazardous properties and widespread exposure of the general population should have given companies ample warnings for the need to move away from BPA. We therefore strongly recommend to decide for an early LAD (latest application date). This would benefit all companies which have already worked to replace BPA.
However, as we have shown in our report: From BPA to BPZ the replacements are often equally problematic (http://www.chemtrust.org/wp-content/uploads/chemtrust-toxicsoup-mar-18.pdf). RAC already concluded in 2015 that BPS has similar properties as BPA. We therefore consider that urgent action is needed for ECHA to develop a group approach to those bisphenols which are likely to be used as substitutes. In order to avoid regrettable substitution ECHA should also communicate clearly to industry that the intention of the legislators is surely not that they should substitute BPA with other bisphenols or similar substance.
	A.2.02. Urge ECHA to consider regulating alternative bisphenols as a group based on BPA dossiers

B.2.02. Recommendation to decide for early LAD as this would benefit companies already replacing BPA	
				
3395
2018/12/05	Aerospace Industries Association (AIA),
Industry or trade association,
United States	The aerospace sector has here described above many important and diverse uses of formulations containing BPA.  We have also described the complex challenges we face in correctly identifying intermediate uses as well as implications of residual BPA.  Another significant factor is that many formulations are considered proprietary and protected by patent or trade secret and is not necessarily known to OEMs.  Such intellectual property protections limit visibility to the OEMs as well as to the regulatory agencies. Significant time would be necessary to allow for these considerations.  Negotiations on a formulation by formulation basis with each supplier is arduous, time-consuming, and often limited in success.	B.1.1.3. ECHA's proposal for latest application dates

B.1.2.1. Extensive time needed in the supply chain to get organised for preparing application (e.g. due to high number of users)

B.2.01. LAD and the Sunset date should be set the maximum period of 24 months apart

III - Comments on uses that should be exempted from authorisation, including reasons for that
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3310
2018/12/03	Huntsman Advanced Materials (Europe) BVBA,
Company,
Belgium	All remaining non-intermediate uses of BPA in the epoxy industry would justify exemption, since:
• The vapour pressure of bisphenol A is extremely low (4,12.10-9 hPa @25°C)
• In the exposure scenarios in scope, bisphenol A is used as a minor component in liquid or solid mixtures.
These two factors combined result in the fact that airborne exposure to bisphenol A can be excluded.
Thus, the only remaining way of exposure is dermal. All processes in scope are dry, i.e. without water.
When considering dermal exposure, it must be noted that in the uses in scope BPA is always used in combination with epoxy resins, which have been known for decades in the field as skin sensitisers. Therefore, adequate skin protection equipment is always used at all industrial sites as well as by professional users. Thus, dermal exposure to BPA can be excluded.
Safe use is documented in the registration dossier with low RCR values.

As far as release of BPA to the environment, comprehensive measurement data related to surface water contamination with BPA in Europe (e.g. European Risk Assessment Report (2003), Bisphenol A, EUR20843EN) clearly show that the contribution of the activities in scope is extremely low, i.e. in the range of a few 0.01 percent.
Hardeners containing BPA as an additive are in many cases products that have been on the market for many years and are used in critical areas where they had to go through a long qualification process. Spare parts made from these products need to be available for an extended time (sometimes decades), replacement parts for currently operating airplanes could serve as an example. Re-formulated products should not be used as an alternative in these cases as their compatibility cannot be fully ensured. A resulting potential decrease in the safety level (product failure) of currently operating vehicles is not acceptable.
In addition, significant qualification times, for instance up to 10 years (not including any development of replacements), e.g. in the energy generation and transport, and definitely in the aerospace sector, have to be taken into account.
	C.1.3. Aspects not justifying an exemption from authorisation

C.2.01. Claim that a repair-as-produced clause for each substance listed on Annex XIV is necessary so that uses for legacy spare parts are exempted	
				
3313
2018/12/04	ACEM (Motorcycle Industry in Europe),
Industry or trade association,
Belgium	see attachment	Please see references to responses in section I	
		See the corresponding embedded attachment in table 1 of Part I: 
3313_ACEM response to Public Consultation on BPA inclusion Annex XIV.pdf		
3317
2018/12/04	TEDAE,
Industry or trade association,
Spain	BISPHENOL-A

Uses that should be exempted: Preparation of epoxy resins and adhesives used in the aeronautical and aerospace sectors.

It is the opinion of TEDAE that a better regulatory approach will be to not regulate Bisphenol A by authorization (Annex XIV) but by means of a restriction (Annex XVII) in an industrial environment like aerospace and defense due to the negligible exposure to end customers and the manageable exposure risk to workers and the environment.

Justification:
Bisphenol A is present in candidate list since January 2017 following REACH Article 57c and its toxicity for reproduction. The direct use of Bisphenol A in the Spanish aerospace and defense industry is extremely limited to very specific products, and the presence in the final product is considered as a non-desirable residual.

However, Bisphenol A is used as raw material in the chemical industry for the production of epoxy compounds. These epoxy resins can be obtained as reaction products of Bisphenol A (i.e. BADGE, CAS 1675-54-3) and are essential for a critical range of applications:

• CO2 emission reduction: by the continuous deployment of epoxy resins as part of composite materials weight savings in the industry have successfully  reduced fuel consumption of our products, driving to overall reduction of CO2 emissions. Airplanes contained today >50% of composite materials and new generation of airplanes have achieved 20% of fuel savings compared to previous metal based generations. Epoxy resins have a key contribution in these achievements.
• Higher usability of products: by the introduction of fast curing epoxy based adhesives, the aerospace and defense industry can reduce the time aircraft are grounded by reducing maintenance time, driving to a better utilization of raw materials used in the aircraft.
• Fast manufacturing processes: by the introduction of fast curing epoxy resins, curing time and, therefore, energy consumption during composite manufacturing can be significantly reduced driving to energy savings in aerospace and defense production.

Inclusion of Bisphenol A in Annex XIV might drive to conflicting regulatory requirements between optimization of raw materials and CO2 emissions compared to the REACH objective to reduce Bisphenol A human exposure. Being used mainly as an intermediate inside identifiable industrial environments it provides a highly controlled and minimised exposure risk.

Therefore, it is the opinion of TEDAE that a better regulatory approach will be not to regulate Bisphenol A by authorization (Annex XIV) but by means of a restriction (Annex XVII) in an industrial  environment like aerospace and defense due to the negligible exposure to end customers and the manageable exposure risk to workers and the environment.

	A.1.5.1. Potential other regulatory actions

C.1.1. General principles for exemptions under Art. 58(2)

C.1.3. Aspects not justifying an exemption from authorisation	
				
3318
2018/12/04	Comité FRANCECLAT,
Industry or trade association,
France	We are the Comité FRANCECLAT, the French Watch, Clock, Jewellery, Silverware and Tableware Committee.
We would like to contribute to the ongoing public consultation on ECHA's draft recommendation on the integration of bisphenol A into Annex XIV of the REACH Regulation.
The watch and jewellery sectors, like many other sectors, use epoxy adhesives as part of their business. Lacquers (colored epoxy resins) are also used to decorate pieces of jewellery and watches. They are usually applied by paintbrush or syringe in very small quantities.
The safety data sheets of the products used (adhesives and lacquers) mainly mention the presence of bisphenol A diglycidyl ether - BADGE (CAS n °: 25068-38-6 and EC n°: 500-033-5) and sometimes of bisphenol A / F (CAS n°: 40216-08-8) but never of bisphenol A as such (CAS n°: 80-05-7, EC n°: 201-245-8). Therefore, uses of these products are not affected by the inclusion of bisphenol A in the REACH authorisation process.
When bisphenol A was proposed to be identified as a Substance of Very High Concern, we nevertheless participated in the public consultation because it seemed to us that part II of the report prepared by France in accordance with REACH Annex XV on the identified uses and potential alternatives of bisphenol A might be confusing for companies.
Indeed, among the most frequent uses of bisphenol A, highlighted in the report, were the epoxy resins. The section devoted to these resins focused mainly on the use of BADGE and not on that of bisphenol A as such (page 16 to 36). Indeed, the applications listed as well as the potential alternatives identified mainly concerned epoxy resins (mostly made of BADGE).
Since the identification of a substance as a SVHC and its inclusion in the Candidate List can trigger certain legal obligations for the importers, producers and suppliers of an article that contains such a substance, it seemed important to us, in the context of the inclusion of bisphenol A, that it be clear that its obligations only concern products and articles containing bisphenol A and not all products and articles containing BADGE, or all products and articles made of epoxy resin.
In addition, on page 14 of this report (in an asterisk under the table listing potential applications of bisphenol A), it was stated that bisphenol A can be considered as an intermediate when it is transformed into BADGE that is the monomer in the production of the resin. This intermediate use in the synthesis of the BADGE could thus benefit from the generic exemption of the authorisation process relating to the intermediates. It also seemed important to us to highlight this point, which was only briefly mentioned in the report.
The French Agency for Food, Environmental and Occupational Health & Safety (ANSES), in charge of responding to the contributions concerning bisphenol A, responded to our contribution by confirming that the authorisation process only concerned bisphenol A and not the BADGE.  ANSES also confirmed that, in the case of BADGE-based epoxy resins contained in adhesives, varnishes and lacquers, bisphenol A was well regarded as an intermediate and was therefore not subject to the authorisation process.
As part of this second stage of the authorisation process, which is ECHA's recommendation for an introduction to Annex XIV of the REACH Regulation, we were particularly attentive that there was no longer any ambiguity about this last point.
We therefore highly appreciated that Appendix 1 of the report accompanying the draft recommendation confirms that the use of bisphenol A for the manufacture of epoxy resins is considered intermediate use and therefore is outside the scope of authorisation.
While aware that this type of clarification is not mandatory since it is the companies that are responsible for determining whether the use of a substance included in the authorisation process benefits from a process generic exemption, this kind of information seems to us to be particularly important and useful for a good implementation of the authorisation process measures in companies.
Indeed, the authorisation process is extremely difficult for SMEs to understand, mainly those that do not come from the chemical industry, as is the case for the watch and jewellery sectors. Any information that can remove doubts and avoid confusion seems to us the best way to enhance the efficiency and effectiveness of the authorisation process.
	A.2.07. Interpretation that use in hardeners for epoxy resins is intermediate use

A.2.09. Uncertainty as to whether only uses of BPA as such fall under the authorisation requirement or also uses of epoxy resins based on BPA as monomer

Thank you for your opinion.	
				
3325
2018/12/05	ADS Group Limited,
Industry or trade association,
United Kingdom	Outlined above, but in addition, ADS understands that Bisphenol A is used as monomer for the manufacture of polymers, specifically but not limited to polycarbonate and epoxy resins. Any substance used as a monomer in the manufacturing of a polymer is by definition an intermediate and as such is outside the scope of authorisation.

Equally ADS recognises the fact that ECHA have determined that BPA meets the requirements to be classified as an SVHC.

Consequently ADS requests that ECHA introduces appropriate Risk Management Options which will ensure worker safety without the necessity of Authorisation.
	A.1.5.1. Potential other regulatory actions

A.2.07. Interpretation that use in hardeners for epoxy resins is intermediate use	
				
3388
2018/12/05	CHEM Trust,
National NGO,
United Kingdom	This comment questions the appropriateness of the generic exemption regarding uses in food contact materials.

We are aware that it is not possible for the REACH Authorisation system to address health aspects of food contact materials according to the existing general provision in REACH article 56.5.b). However, the fact that BPA is authorized for use in plastic materials and article to come in contact with food despite being classified as a reprotoxic chemical with endocrine disrupting properties for human health and the environment seems to be at odds with the intention to achieve higher level of protection by reducing exposure to BPA.
We therefore call on ECHA to approach EFSA and the Commission to discuss necessary adaptations in the area of food contact materials following the designation of BPA as an SVHC and inclusion in Annex XIV. In our view the current situation calls for a closer and more systematic link between SVHC identification and subsequent restrictions of uses in food contact items.
	C.2.02. Questioning the appropriateness of generic exemption regarding uses in FCM