Contents

This publication is also available online in a web-accessible version at https://pub.norden.org/temanord2022-567.

Summary

In this report, recommendations are made regarding minimum requirements for Exposure Scenarios (ESs), which are required as part of chemical assessments according to Article 14-3 of Regulation (EC) No. 1907/2006 (REACH). Based on previous work done on this topic, a list of minimum requirements was proposed and two practical ES examples were prepared. The two ES examples were prepared with two specific hazardous substance groups in mind. The proposed list of minimum requirements together with the two practical ES examples were distributed together with a survey, to companies both within the SME and non-SME sector. The survey contained general questions regarding the respondents’ experience with and understanding of ESs, and specific questions to the proposal for minimum requirements and practical ES examples. The survey and related documents were created in English and translated to Norwegian, Swedish, and Danish. 

Responses were received from 70 companies, of whom about half were SMEs and half not, in terms of number of employees. All in all, the proposal for minimum requirements and the practical examples were well received. According to the respondents, existing ESs show a high degree of variation, and the respondents were clearly in favour of a harmonisation/standardisation of ESs. The survey uncovered a significant need for a raised understanding and more knowledge on ESs, particularly among SMEs.

It is concluded that harmonisation is recommended, e.g. in terms of legal requirements for ES contents. Based on the survey findings, specific recommendations are given to ES compilers, downstream users, industry/trade associations and authorities. 

Glossary

1 Background

This report is a result of the project “Identification and assessment of exposure scenario minimum requirements”, initiated by the Nordic Exposure Group, Human Health and Environment (NEXPO), and funded by the Nordic Council of Ministers through the Nordic Chemicals Group. Kiwa Kompetanse AS has had the role as project consultant in the project. 

The aim of the project, as described in the project mandate, has been to contribute to building a clearly defined structure on minimum requirements for exposure scenarios (ES) required as part of chemical assessments in accordance with Regulation (EC) No. 1907/2006 (REACH), Articles 14(3) and 14(4). This would allow for a systematic approach for ES development, where in the least the essential and relevant information would be recommended to be provided by the registrants. Establishing a set of minimum requirements, which are both practical and enforceable, as the basis for ES preparation would significantly improve the information level for all ES prepared in EU/EEA and reduce the problem of ES lacking vital safe use information. Nonavailability of a structured approach for ES preparation has been a problem affecting both suppliers (manufacturers/importers), users of chemicals as well as being a challenge to enforcement authorities. The project was to focus particularly on SMEs.

More specifically, the objective of the project was to produce the following deliverables:

1. A list of suggested minimum ES requirements, building on existing material from earlier work on this subject. The ES layout/format was not to be a focus, but rather the contents which should as a minimum be included in an ES. 
2. Practical ES examples for substances of high hazard/concern, based on the list of minimum requirements.
3. A survey for companies who are (potential) recipients of extended SDSs with ESs to be sent out together with the documents described above, in order to evaluate their usability. 

In the current report, the preparation of each these deliverables are described in detail. The findings from the survey are summarised and discussed. Finally, recommendations for the further work on defining minimum ES requirements are given, in addition to some other reflections based on the survey participant’s feedback regarding extended SDSs and ESs in general. 

2 Methods

Preparation of the list of proposed minimum requirements and practical examples

The list of minimum ES requirements, and the practical examples, were as far as possible based on already available guidance, templates, and other related documents and information, including the following:

• Proceedings from workshop on REACH Review Action 3: Improving the workability and quality of extended Safety Data Sheets (ECHA, 2019a and 2019c)
• REACH Review Action 3: Development Plan (ECHA, 2020) Downstream users’ information needs under REACH – Summary of market studies in 2017–18 (ECHA, 2019b)
• Checklist – Exposure Scenarios in REACH, A Nordic Group Project 2016 (NEXPO, 2016)
• Guide on Safety data sheets and Exposure scenarios (ECHA, 2018)
• Annotated templates for an Exposure Scenario, found on ECHA’s website^{[1]https://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/formats}
• Illustrative example of Exposure Scenarios (ECHA, 2017) 
• Mapping of the Conditions of use (input parameters) of the different tools for workers assessment (ENES, 2020)
• Use map elements found in the use map library on ECHA’s website^{[2]https://echa.europa.eu/csr-es-roadmap/use-maps/use-maps-library}, including use maps, sector-specific worker exposure descriptions (SWEDs) and descriptions of specific environmental release categories (SPERCs)
• Existing extended SDSs/ESs publicly available on the Internet

The list of proposed minimum requirements was prepared and two practical ES examples were developed, for the made-up substances “Diisocyanate X” and “Triamine X”, representing the following two groups of substances:

Diisocyanates: Group members have CLP hazard classifications (e.g. H317, H334) and specific restrictions which must be followed (cf. REACH Annex XVII). Includes widely used substances in large amounts.

1,3,5-triazine-2,4,6(1H,3H,5H)-trione and 1,3,5-triazine-2,4,6-triamine derivatives: 
Group members have CLP hazard classification (e.g. H361f), and substances for which SVHC intentions have been submitted. Includes widely used substances in large amounts.

The phrases used in the ES examples, for example to describe the use, were based on a combination of use maps for the relevant sector, already existing ES examples published by ECHA based on Chesar, and harmonised phrases as given by ENES (2020). Regarding use maps, the FEICA (Association of the European Adhesive and Sealant Industry) and ESIG (European Solvents Industry Group) use maps were used as the main sources of appropriate phrases describing the use. It was considered important to base this as far as possible on already available phrases and ES elements from various guidance and ECHA templates, instead of creating something new which could potentially add to further confusion and complexity. This way, it was possible to investigate how respondents react to phrases and terms already used and available in various guidance.   

Preparation of the survey

The survey was created using Microsoft Forms. It consists of in total 28 questions divided into three sections: 

1. General company background
2. Experiences with Safety Data Sheets and Exposure Scenarios
3. Questions to the suggested minimum contents of Exposure Scenarios 

Sections 1 and 2 were included in order to get a picture of the respondents’ background and previous experience and see whether this had any implications for their responses to Section 3. This final section included an attachment with proposed minimum ES requirements and two practical ES examples. 

The survey, including the practical ES examples, was finalised after a commenting round within the project steering group (NEXPO).
 

Languages

The survey was prepared in English and translated to Norwegian, Swedish, and Danish. Ideally, the survey should have been available in all Nordic languages, but this was not deemed possible within the boundaries of the project. It was considered that with these languages, respondents from all Nordic countries should have the possibility to respond. The inclusion of an English version also made it possible to distribute the survey beyond the Nordic countries.
 

Distribution of the survey

The following methods were used for distributing the survey to potential respondents:

• Direct e-mails to companies
  Companies within various industries/fields where chemicals are used, were found using a company search at the business information websites www.proff.no, www.proff.se, and www.proff.dk. In order to address primarily SMEs, only companies with a maximum number of employees of 250 were included in the search. The companies were sent an e-mail, using generic e-mail addresses due to GDPR concerns, with information and a survey link. In addition, information about the survey was distributed to companies subscribing to Kiwa’s newsletter on chemicals.
• Distribution via trade associations / branch organisations
  The following trade associations were contacted and encouraged to distribute the survey among their members:
  – The Federation of Norwegian Industries (Norsk Industri)
  – The Confederation of Danish Industry (Dansk Industri)
  – The Danish Association of Cosmetics and Detergents
  – IKEM (Innovation and Chemical Industries in Sweden)
  – The Federation of Icelandic Industries (Samtök Iðnararins)
  – The Chemical Industry Federation of Finland (Kemianteollisuus)
  – DUCC (The Downstream Users of Chemicals Co-ordination Group)
• Open information about the survey on Kiwa’s LinkedIn profile

Analysis of the responses

Responses from the survey versions in all languages were compiled in one Excel document, and everything was translated into English, whereafter distributions of responses were analysed. Since this project has a focus on SMEs in particular, it has been paid attention to whether there are differences in the responses of SMEs vs non-SMEs. 

All survey questions, and the accompanying example ESs, are attached as appendices to the report. 

3 Results and discussion

In total 70 companies responded to the survey. Responses in all languages were received. The main findings from the three parts of the survey are presented and discussed below, while all survey questions and detailed responses are available in Appendix I.
 

3.1 Part 1 – General company background 

About half of the respondents are SMEs, in that they have up to 250 employees, and half have more than 250 employees and are in the context of this report considered as non-SMEs. Also, about half of the respondents are national and international companies (i.e. have offices in several countries), respectively. Most (81 %) of those with offices in several countries are non-SMEs. 

The non-SMEs also have more roles, i.e. many of them both sell, buy and use chemicals. Almost all of the respondents who are manufacturers, are non-SMEs. The non-SMEs more frequently reported that they buy and import chemicals from outside of the EU/EEA – 73 % of non-SMEs buy chemicals from outside of the EU/EEA, whereas 20 % of SMEs report the same. The respondents who are SMEs, are mainly buyers (from companies within the EU/EEA) and users of chemicals. All the non-SMEs handle, i.e. buy, sell, use or produce, many chemicals (50 or more) annually, while there is a larger variation among the SMEs. The SMEs are more diverse regarding the amount of chemicals handled per year.

All but one respondent have some kind of quality system (ISO 9001, 14001 or 45001) or internal routines for the handling of chemicals in place. An inherent aspect of the ISO quality systems is to ensure internal communication, responsibility clarifications and routines in order to be able to comply with relevant legislation. This includes legislation and requirements related to chemicals. Overall, the non-SMEs have more of these systems in place at the same time, whereas the smallest SMEs to a much lesser extent have ISO quality systems – but still, they do have internal routines for chemicals. 

A higher number of respondents would naturally have given more robust findings. However, taking into account that this is a complex topic for many companies, especially SMEs, all 70 responses received are highly appreciated. The respondents largely handle many chemicals, have different roles in the supply chain, and have established routines for their handling of chemicals. It could therefore be deduced that this represents a group of respondents who by and large should have a good starting point for, and some experience with, the safe use of chemicals – including related documents. Their responses can in other words provide valuable insight into companies’ thoughts on and experience with ESs and their contents.

Since half the respondents are SMEs and half are not, the survey findings give an indication of potential differences between these two groups. Table 1 below sums up general company background differences. Further differences – or lack thereof – are also presented for parts 2 and 3 of the survey.

Table 1. General company background differences between the SME and non-SME respondents

3.2 Part 2 – Experiences with Safety Data Sheets and Exposure Scenarios

Of all the respondents, about three quarters have received extended SDSs with ESs. More non-SMEs than SMEs have received ESs – 84 % as opposed to 70 %, respectively. Only 13 % of all respondents thought the ESs they have seen (received or seen elsewhere) have looked similar to each other. The rest thought they have varied both length and/or contents/structure – apart from a rather high percentage (21 %, of whom the majority are SMEs) who responded that they do not have any opinion or experience in the matter.

Clearly, most of the respondents prefer that an ES is as short as possible, only containing strictly necessary information. Overall, no differences could be detected between SMEs and non-SMEs regarding the level of detail wanted in an ES. The only difference is that all the respondents stating that they do not have any opinion or experience regarding the level of detail in ESs, are SMEs.

Many of the respondents already have routines in place for checking ESs. However, while 62 % of non-SMEs have such a routine in place, only 27 % of the SMEs do. In fact, 18 % of the SMEs (and only 3 % of the non-SMEs) responded that if they receive an extended SDS with an ES, they will not look at the ES. Most of the respondents, regardless of company size, would take a look at the ES and try to understand it, without following a particular routine.

The majority of the respondents, regardless of company size, find that ESs sometimes contain relevant information for their use. Similarly, the majority experience that it is sometimes easy to find this relevant information. The most notable difference between SMEs and non-SMEs when it comes to finding relevant information in an ES, is that more of the SMEs have responded that they have no opinion or experience.

Of the alternatives presented in the question on general understandability of ESs, the most frequently chosen reply by the respondents (both SMEs and non-SMEs) was that ESs contain too many codes and abbreviations. This is in agreement with the findings from a question in part 3 of the survey, where a clear majority would want a list of abbreviations at the start of an ES. Further, 41 % of all respondents indicated that ESs generally are difficult to understand. With regard to the background of the respondents, e.g. that many of them should be quite resourceful when it comes to chemicals (about half of them have an established routine for ES checking), it is interesting to note that only 14 % of the respondents think that ESs are generally easy to understand. 

The survey also uncovered that 61 % of the SME respondents do not know where to find guidance on how to deal with and understand ESs. For the non-SMEs, more of the respondents know where to find such guidance. 

Breakdown of those responding that ESs are generally difficult to understand: 

– 65 % are non-SMEs and 35 % are SMEs
– 92 % handle 50 or more chemicals during one year
– All have received extended SDSs, with ESs
– 58 % have an established routine for checking ESs
– 81 % experience variation both in length and contents/structure of ESs
– 81 % think ESs are often too long
– 81 % think there are too many codes and abbreviations in ESs

A clear majority (84 %) of all respondents agree that it could be useful if ESs looked more similar, i.e. had a more standardised format. This can be considered a strong support for ongoing efforts to harmonise the ES contents and format.

84 % of all respondents agree that standardisation of ESs would be useful.

Some examples showing differences and similarities between SMEs and non-SMEs regarding the responses to part 2 of the survey are shown in the Table 2.

Table 2. General ES experience and opinions (some examples), SME vs. non-SME respondents

3.3 Part 3 – Questions to the suggested minimum contents of ESs

When asked for their first impression on the suggested minimum ES contents with two practical examples, 86 % of all respondents found it to be either good or a step in the right direction. In other words, the proposal and examples were generally well received among the respondents. There were no particular differences between SMEs and non-SMEs in this respect. Please see Figure 1 on the following page for the suggested minimum contents, and the practical ES examples in Appendices IIa-d.

The respondents were also encouraged to give additional explanatory comments. All comments received can be found in Appendix I. Some of the comments given by respondents who found the proposal to be a step in the right direction are shown below: 
 

It should be more user-friendly otherwise people won’t use them. In general ES information requirements should be entered in the main body of the SDS.
 

ES are too complicated to understand by non-experts, HSE services in plants need help from experts. ES must be short, readable and understandable by non-experts.
 

Better than the 197-page exposure scenarios we have received!
 

Figure 1. The suggested minimum ES contents, as presented to the survey respondents. 

The idea to include a list of abbreviations at the start of the ES was well received. 63 % of the respondents think this is a good idea, with no particular differences between SMEs and non-SMEs. However, 24 % of all respondents (32 % of the non-SMEs) were of the opinion that the abbreviations used in the ES should rather be in a common list of abbreviations elsewhere in the SDS. What is clear, though, based on the responses to part 2 of the survey, is that many think ESs contain too many codes and abbreviations. In cases where the ES is an annex and not incorporated into the main SDS body, it could be argued that it would be simpler for the reader to have the abbreviations presented at the start of the annex. 

In the practical examples, ES titles were taken from use maps, chosen based on the foreseen use of the example substances. One of the ES titles used in the examples, taken directly from the FEICA use map, was “Widespread Use by Professional Workers; Adhesives, Sealants (PC 1); small scale application of adhesives, sealants or primers”. When asked whether this title describes what the scenario covers in an understandable way, 68 % of the respondents gave a positive answer (no difference between SMEs and non-SMEs). 

Similarly, the majority (60 %) also thought the proposed minimum requirements for the Title Section, illustrated by practical examples, give a clear picture of what the scenario covers. It should be noted that more of these respondents were non-SMEs than SMEs. The Title Section examples are presented in Figure 2 on the following page.

Those who thought the Title Section did not give a clear picture (in total 27 %), found that there was too little or too much information, or that it was difficult to understand. The following are some of the explanatory comments received from these respondents:

The title section is good and provides enough information for the exposure scenario presented. … The issue is that by making it so specific, we might end up with an infinite number of permutations (smaller, as less procs will apply to each), that would make a manufacturer SDS too long. The issue is how many of these scenarios you have to have as a manufacturer of a base substance that has multiple applications? … More guidance should be provided to formulators to scale and describe those ES in their SDS, but not at the manufacturer level. Better training and understanding how to do SDS and scaling (engage occupational health professionals) would be key for this.
 

In ES1, the use is described as “small scale application”. In “Contributing scenarios, environment” it says “wide dispersive indoor use “ and “widespread use”. Does this mean that these are examples of scenarios where it is not used as intended in small scale? Difficult to understand. How are these terms defined? 
 

The title section should only contain a use title and the Life Cycle Stage. The use descriptors are useless (e.g. PC and SU are not part of the worker risk assessment, and should therefore not be included, and they don’t mean anything to the user.) If the identified use is “use in coatings” LCS: Industrial. would that mean that I cannot use it as a coating if I don’t find an applicable SU? If so, how is the SU part of the risk assessment? If an option is chosen “all SU” would that be better?
 

Descriptions need to be simple, so that a non-expert can understand them.

Figure 2. A compilation of the three title sections from the practical examples (example 1 contains two ESs and example 2 contains one ES), as presented to the survey respondents.

Regarding section 2, conditions of use affecting exposure, the majority of the respondents (56 %) thought the proposed minimum requirements illustrated by practical examples give a clear picture of what is needed for safe use. Also here, more non-SMEs than SMEs gave a positive answer. One of the Section 2 examples is presented in Figure 3 on the following page.

Those who thought section 2 did not give a clear picture (in total 29 %), found that there was too little or too much information, or that it was difficult to understand. The following are some of the explanatory comments received from these respondents: 

The headlines for each section are difficult to understand, even if the contents are understandable.

“Covers use up to”, “Covers concentrations up to”, “Covers use at ambient temperatures” – what covers? Does it mean that the information only applies to these conditions? Duration of exposure of 365 days/year – you don’t work 365 days a year, what if you work 67 days? Many questions arise about what this really means. 

If the only goal is to see if use is covered, there should be clear criteria for that. What if the use is a bit outside the boundaries? … Would it not be better to focus on parameters that can be influenced? Workers: amount used is not part of a risk assessment tool, so not relevant at all. Neither is frequency. Measures to be taken is the most important one. However, we already control exposure as required by the OSH legislation. The ES information could be conflicting with our own internal workplace risk assessment.  As the OSH workplace risk assessment is specific for the workplace, is that considered the better option?

In addition, several respondents, regardless of whether they thought the Section gave a clear picture or not, commented that the information given in the Section 2 example is similar to what would already be in section 8 of the main SDS body. If there is similar information several places, but this is not completely identical, you would need to look at all the different places and compile your own document. This makes it more difficult to go through the SDS and identify the necessary measures.

The survey furthermore shows the importance of the exposure estimates usually present in Section 3, although this is particularly true for non-SMEs. The SME respondents have to a lesser extent needed to use these numbers. The same applies to scaling – non-SMEs have had the need to do scaling to a larger degree than SMEs.

Table 3. Opinions on the suggested minimum requirements (some examples), SME vs. non-SME respondents

Figure 3. Section 2 from example 2, ES 2, as presented to the survey respondents.

As a conclusion of the survey, the respondents were invited to give any further comments on ESs, related to the survey or otherwise. All comments are given in Appendix I. Some examples are presented below:

The ES attached to a SDS has no added value to an existing, well written SDS. All ES are much too complex, unclear and not understandable for any end user. Lots of information is repeated several times in several paragraphs of the same ES. 

Thank you for initiating this effort.  Harmonization of SDS (and even requirements for RMMs) is very useful and might streamline the communication through the value chain. 

We support having a harmonised format, as that would improve data collection and customer comprehension. We often have to chase suppliers for the ES, they don’t send them out with their SDS, or have them available on their websites. This means we in turn struggle to provide ES to our customers.

ES need to be much easier to understand and use in practice. Also, the legislation needs to be clarified regarding who need to make ES, how they should look and which rules apply from a working environment perspective.

I think that this is still a complicated way for the description how to use a product in a safe way for the “common” professional user.

Exposure scenarios are generally not useful. We often see automatic translations (sometimes it’s just comical), which make it impossible to understand the contents.

4 Recommendations

4.1 The suggested minimum ES contents 

The list of suggested minimum contents (as presented to the respondents) is repeated below, together with specific comments and recommendations based on the survey responses. The following main findings are particularly kept in mind: 

• There is strong support for a harmonisation/standardisation of the ES contents. 
• The list of suggested minimum contents with practical examples was all in all well received. 
• The ES should be as short as possible or something in between short and detailed.
• Confusion around already available (proposed) harmonised phrases is widespread.

Comments based on survey responses:

This introductory information at the very start of the ES is important in order for the readers to be able to navigate in the document and find relevant information. A table of contents (in case of several scenarios in the same annex), as well as a list of abbreviations, should be included for this purpose. 

Many respondents lack an understanding of basic phrases which are already harmonised. Examples are confusion regarding “widespread use” and “small scale application” being mentioned in the same ES title. Some think these terms contradict each other, when in fact widespread means that the substance is used at many sites or by many users whereas small scale refers to a small-scale use at each individual site or by each individual user. It is not evident for all that “Covers up to…” refers to the exposure assessment – i.e. that concentrations within this limit are regarded as safe provided that other conditions and measures are in place. Explaining all these terms in the ES annex would on the other hand lead to a very lengthy document. It is therefore instead proposed that more efforts are made to make ES guidance more well-known within the industry, particularly for SMEs. 

Comments based on survey responses: 

In general, these minimum requirements for the Title Section with examples were mostly found to give a clear picture of what the ESs cover. There are however some general misconceptions around the use descriptors. Some respondents have trouble identifying the right PROCs and ERCs for their use. This points toward the need for more knowledge on ESs among the companies (more on this below). Some think the information should be detailed, while others think too detailed/specific descriptions of e.g. processes, tasks, activities covered necessitate many different ESs and a complex structure, and are therefore in favour of keeping it simple and more generic. 

In order to avoid confusion, it is important to ensure that the uses mentioned in the main SDS, section 1, and the uses in the ES, are in line with each other.

An absolute minimum for the Title Section should be the use name, a description of activities covered, PROCs and ERCs/SPERCs. This would allow the end user to see whether their use of a chemical is covered by the ES, and it would give basic information of how the exposure assessment has been done. Basic information on the chemical already given elsewhere in the main SDS body, need not be repeated here.

Comments based on survey responses: 

The proposed minimum requirements and practical examples for Section 2 were also all in all well received. However, SMEs in particular had some trouble understanding this section. Comments were received on the lack of clarity, misunderstandings of terms, and the fact that this section contains information which already is, or perhaps should be, in the main body of the SDS. Especially when it comes to conditions and measures related to personal protection, the relationship between Section 8 of the SDS, and Section 2 of the ES Annex, should be considered carefully. According to the survey findings, there is a need for a better understanding regarding the fact that the SDS main body (e.g. Section 8) gives general information on the chemical based on its inherent properties, whereas the ES gives specific information related to particular uses of a substance. In practice, based on examples from existing eSDSs and to some extent based on (proposed) harmonised phrases, this distinction does not always seem so clear. The following is an example of a phrase for harmonised communication to be used in ESs, from ENES (2020):

Wear a respirator which reduces the air impurities by at least a factor of 4 (APF ≥ 4). For further specification, refer to section 8 of the SDS.

For the recipient of the ES annex, it may not be clear why this is not simply inserted into section 8 of the SDS in the first place – if they do not have an understanding of which information belongs where. 

Also, some comments were received regarding other languages than English. Understandably, automatic translation is not a good solution. When working with this report, it was found that harmonised phrases are not easily available in all Nordic languages. Harmonised phrases should ideally be translated in cooperation with end user representatives / trade associations to ensure that they are understandable for the ES recipients. 

Comments based on survey responses: 

The exposure estimates are considered important by many respondents, in particular non-SMEs. Those who have needed to use the information in Section 3, reported that they have needed to see the RCRs and release factors, and of course a reference to the models/calculations used. The SME respondents have less experience with using the information in this section actively – it is not impossible that this partly can be caused by a lack of understanding regarding the exposure estimates and how they should be used. 

It could be helpful with an explanation at the start of Section 3, saying that if you do in fact follow all conditions and RMMs, it is not necessary to pay further attention to these numbers.

Comments based on survey responses: 

About a quarter of the respondents have needed to perform scaling – most of them are non-SMEs. Some commented that scaling is too complicated for non-experts. Some had to contact the supplier and ask them to do the scaling. The information here should be as simple and precise as possible. The guidance on what should be included here, as reflected above, is in many cases not followed. It is recommended that these should be parts of the minimum requirements.

4.2 ES contents specifically for the chosen substance groups 

The practical examples were created in order to show in an attempted realistic manner how the suggested minimum required contents could be used in practice. The two substance groups are repeated here (read more about this in the Method chapter):

• Diisocyanates
• 1,3,5-triazine-2,4,6(1H,3H,5H)-trione and 1,3,5-triazine-2,4,6-triamine derivatives

In the example ESs, (proposed) harmonised phrases were used as far as possible. These were found in use maps (e.g. SWEDs) for known uses of these groups of substances, in existing ECHA examples and by ENES (2020). Where available, phrases relating to the inherent properties of the substances were used.

Since it was important to focus on SMEs within this project, it was considered the most important to distribute the survey to as many SMEs as possible. Respondents were not chosen based on known use of substances within these two groups. Many of the SME respondents still need more information and a better understanding of ESs and why they are needed, before they can respond in a detailed manner regarding which information to include for which substances. However, the general opinion from the survey is that the examples were useful. 

In order for the ES recipients, and ES compilers, to get a better understanding of which ES elements are critical for which substances, it is important to increase the level of knowledge and understanding around use map documents and other sources for harmonised phrases. This also include making translations of harmonised phrases easily available in all languages. Much effort has been invested both by authorities and industry/trade associations, in defining common phrases and use conditions in English. This is not as readily available in other languages. Experiences show that it is hard to find trustworthy translations. Harmonised phrases should ideally be translated in cooperation with end user representatives / trade associations to ensure that they are understandable for the ES recipients.

4.3 The need for increased knowledge on ESs 

This point cannot be stressed enough and is vital for the success of ESs for communication in the supply chain. With 40 % of all respondents (61 % of SMEs) not knowing where to find any guidance on ESs, it is clear that effort is needed to make the already abundant guidance more well-known – and also more accessible in all languages. Based on the background of the respondents to this survey, it is anticipated that the real need in the market for basic information about ESs among end users and in particular SMEs, is significant. It could be presumed that the companies who have in fact responded, have more knowledge than many of those who have not responded – since one would need some kind of knowledge on ESs, at least know what they are, to understand the survey e-mail/information. 

It is therefore important to emphasise the following: The survey results indicate that in addition to focusing purely on which information items should be present in an ES, there should still be a considerable focus on providing basic guidance and understanding among ES recipients.

Seen from the companies’ point of view, they must have the overview over an extensive amount of legislation and requirements. Many are familiar with the “normal SDS” and that this contains the most important information relating to a specific chemical. They already use the SDS as a basis for local risk assessments which must be performed at each workplace. 

For many, SMEs in particular, the ES represents a change to the well-known structure of the SDS. Without clear information on which information goes where, and without explanation of why ES information often is in a separate annex instead of being incorporated into the standard SDS body, many companies will be confused. There is a chance that important information from the ES goes unnoticed with the end user, i.e. the intended recipient of this information. The findings of this survey emphasise this point: Several of the respondents commented that they are confused regarding what information to find where, and that they would prefer the ES information to be integrated into the body of the SDS instead of having it as a separate annex. 

It is not always a practical, or possible, solution to incorporate ES information into the main body of the SDS, but for those cases where this is possible (e.g. for simpler eSDSs with few uses and where the entire eSDS applies to a single substance), it is recommended to encourage incorporation into the main SDS body.

4.4 Summary of recommendations

Recommendations to compilers of ESs (manufacturers/importers)

1. Use available harmonised phrases when creating the ES. Ensure that all necessary information to describe the use, and necessary conditions to ensure safe use based on the inherent properties of the substance, is included.
2. Seek guidance or training on ESs. ECHA has published several, and useful, ES guidance documents and ES examples. 
3. Avoid automatic translations (Google Translate or similar). Use officially translated phrases, or phrases translated by industry associations, where available.
4. Keep the ES short and simple. It should not contain all information from the CSR. Follow (proposed) harmonised templates as far as possible and ensure that the minimum requirements, e.g. as proposed in this report, are included.
5. Remember that the end user might not be familiar with the ES structure and terminology. Include a table of contents to ease the navigation through the ES, and include a list of abbreviations at the start of an ES. 
6. For simpler ESs, consider incorporating the ES information info the main SDS body instead of making a separate annex. Keep in mind that the downstream user must comply with ES conditions. 

Recommendations to recipients of ESs (downstream users) 

1. Seek guidance or training on reading and understanding ESs. 
2. Request an open dialogue with suppliers and ask them in case of uncertainty or confusion regarding received ESs.
3. Use industry/trade associations as a source of information, in addition to the authorities. Pay attention to any campaigns or calls for input and participate actively. It is important that the opinions of SMEs are heard if the ES is going to succeed as a communication document in the supply chain. 

Recommendations to industry/trade associations 

1. Industry/trade associations can be a useful information hub for many companies trying to understand legislation which is common for the sector or branch. Industry associations have already put considerably effort into mapping uses and providing input to ES guidance. It is recommended to build upon this good foundation and think that national industry associations can be of good help when it comes to raising the general knowledge of the ES concept among their countries’ SMEs in particular. 
2. It is recommended that harmonised phrases for communication in ESs, and use descriptions from industry use maps, are translated to all EU/EEA languages and made easily available. This is important for the harmonisation/standardisation of ESs. It would lead to less uncertainties for those compiling the ESs as well as a higher degree of recognising familiar phrases for end users. The translation work could be done by the industry itself or as a joint effort between authorities and the industry.  The main point is that the translations must be understandable for the end users. 

Recommendations to national authorities

1. The requirements for ESs should be more clearly specified than they are today, e.g. as legal requirements. Today, the ESs are varied in contents and length, and this adds to the already widespread confusion around ESs, particularly among SMEs. A clear majority of the respondents welcome a harmonisation/standardisation of ESs.
2. The suggested list of minimum contents presented in this report and as discussed in Chapter 4.1, can be used as a basis for the further work among the national authorities on defining ES requirements. This list is already based on available guidance and examples, and the survey indicates that it is generally well received and supported. 
3. It should be acknowledged that to SMEs in particular, but not exclusively, ES terms and phrases used can be difficult to understand. However, taking into account 1) the effort already made by industry associations to map uses and assign harmonised phrases for communication, and 2) that most respondents prefer the ES to be as short as possible, it is not recommended to address this by adding further explanations to the ES and hence elongating it. Instead, it is recommended to focus the further effort on increasing the knowledge and understanding within a broader group of ES recipients, including SMEs (see next point). 
4. Information and guidance on ESs should be tailored particularly to SMEs and made available in all languages. This is crucial if the ES is to function as a communication medium in the supply chain. ES recipients need to know how to use the ES information in practice, and they need to understand why they need this document in addition to the standard SDS. There are many misconceptions and misunderstandings around this. It was not an aim of this project to assess how general ES information and guidance should be provided to SMEs, but since it became so clear from the survey responses that there is a major need of an increased understanding of ESs, it would be negligent not to point it out. Authorities have an important role, and obligations, in providing information to those who are implicated by legal requirements. Ideally, guidance, awareness campaigns on the practical use of ESs, or similar efforts, should be based on a cooperation between authorities and industry representatives such as industry/trade associations, so that the guidance’s usefulness can be ensured. 

‌5 References

ECHA (2017): An illustrative example of the exposure scenarios to be annexed to the safety data sheet, Part 2: Example, June 2017. Reference no. ECHA-17-H-06-EN

ECHA (2018): Guide on Safety Data sheets and Exposure scenarios, June 2018. Reference no. ECHA-18-G-07-EN

ECHA (2019a): Workshop on REACH Review Action 3: Improving the workability and quality of extended Safety Data Sheets, 18 March 2019 – Summary of the feedback collected from the workshop participants and material used 

ECHA (2019b): Downstream users’ information needs under REACH – Summary of market studies in 2017–18, June 2019. Reference no. ECHA-2019-R-14-EN

ECHA (2019c): 2nd Workshop on REACH Review Action 3: Improving the workability and quality of extended Safety Data Sheets, 18 March 2019 – Summary report of the discussions. Final Version, 11 November 2019

ECHA (2020): REACH Review Action 3: Development Plan, Working draft v.3.2; 03.11.2020 (Annex to CARACAL Paper on REACH Review Action 3 – Current State of Play, 37th CARACAL Meeting, CA/60/2020)

ENES (2020): Mapping of the Conditions of use (input parameters) of the different tools for workers assessment, December 2020

NEXPO (2016): Checklist – Exposure Scenarios in REACH, A Nordic Group Project 2016. NA2017:906, ISSN 2311-0562

6 Appendices

Appendix I:  Survey on Exposure Scenarios – all questions and responses

Appendix IIa: Attachment to section 3 of the survey
Appendix IIb: Bilaga till del 3 av enkäten
Appendix IIc: Vedlegg til del 3 av spørreundersøkelsen
Appendix IId: Vedlæg til del 3 af spørreundersøgelsen

Appendix I: Survey on Exposure Scenarios – all questions and responses

Section 1: General company background
 

Comment to the chart: Options are sorted after frequency of responses. Multiple answers possible, the x axis represents the absolute number of responses.

Comment to the chart: Single answer required, the y axis represents the percentage of responses.

Comment to the chart: Single answer required, the y axis represents the percentage of responses.

Comment to the chart: Single answer required, the y axis represents the percentage of responses.

Comment to the chart: Options are sorted after frequency of responses. Multiple answers possible, the x axis represents the absolute number of responses.

Section 2: Experiences with Safety Data Sheets and Exposure Scenarios
 

Comment to the chart: Single answer required, the y axis represents the percentage of responses.

Comment to the chart: Options are sorted after frequency of responses. Single answer required, the x axis represents the percentage of responses.

Comment to the chart: Options are sorted after frequency of responses. Single answer required, the x axis represents the percentage of responses.

Comment to the chart: Options are sorted after frequency of responses. Single answer required, the x axis represents the percentage of responses.

Comment to the chart: Options are sorted after frequency of responses. Single answer required, the x axis represents the percentage of responses.

Comment to the chart: Options are sorted after frequency of responses. Single answer required, the x axis represents the percentage of responses.

Comment to the chart: Options are sorted after frequency of responses. Multiple answers possible, the x axis represents the absolute number of responses.

Comment to the chart: Single answer required, the y axis represents the percentage of responses.

Comment to the chart: Options are sorted after frequency of responses. Single answer required, the x axis represents the percentage of responses.

Section 3: Questions to the suggested minimum contents of exposure scenarios

Please see the attachment – which can also be found here: 
https://www.kiwa.com/4a6181/globalassets/norway/filer/attachment-to-es-survey_en.pdf

Comment to the chart: Options are sorted after frequency of responses. Single answer required, the x axis represents the percentage of responses.

Comment to the chart: Options are sorted after frequency of responses. Single answer required, the x axis represents the percentage of responses.

Comment to the chart: Single answer required, the y axis represents the percentage of responses.

Comment to the chart: Options are sorted after frequency of responses. Single answer required, the x axis represents the percentage of responses.

Comment to the chart: Options are sorted after frequency of responses. Single answer required, the x axis represents the percentage of responses.

Comment to the chart: Single answer required, the y axis represents the percentage of responses.

Comment to the chart: Single answer required, the y axis represents the percentage of responses.

Comment to the chart: Single answer required, the y axis represents the percentage of responses.

Appendix IIa: Attachment to section 3 of the survey

Survey on exposure scenarios in safety data sheets

Contents

• Suggested minimum contents of an ES (Annex to SDS)

• Example 1: ES for the fictional substance “Diisocyanate X”

• Example 2: ES for the fictional substance “Triamine X”

In this attachment you will find a proposal for what an exposure scenario (ES) should contain as a minimum, and two examples of how this can look in practice. In section 3 of the survey, you will find some questions connected to this.

Both examples represent annexes to an SDS. 
Example 1 contains two ESs, example 2 contains one ES.

NB! Format/layout is not an important part of this survey. We kindly ask you to focus on the contents, not the presentation.

GENERAL INFORMATION ABOUT THE SURVEY

The aim of this survey is to collect experiences and opinions from recipients (current or future) of safety data sheets with exposure scenarios (ES). Your responses will help us get a picture of whether ESs “work” or not for downstream users, and which information it is important that they contain. This is your chance to influence! 

What will we do with your responses? We (Kiwa Kompetanse) will summarise the responses in a report. This report will be sent to the working group for chemicals, within the Nordic Council of Ministers, with representatives from the chemicals authorities in the Nordic countries. They have initiated this project. They want feedback from the companies, in order to have a good basis for their further work with ESs – for example on standardisation or minimum requirements for contents. 

We would very much like to receive your response! Nothing is right or wrong here, we want honest feedback.

The survey is divided in 3 sections, and will take up to 20 minutes, depending on how detailed a response you want to give. 

Section 1: General information about the company
Section 2: Experiences with safety data sheets and ESs
Section 3: Questions to the suggested minimum contents of ESs

The survey is anonymous. Responses are not linked to individuals or companies. 

The deadline for responses is Wednesday 5 October. 

Questions about the survey? Direct your questions to Solveig Aamodt at Kiwa Kompetanse: solveig.aamodt@kiwa.com 
 
Thank you – your contribution is valuable!

Suggested minimum contents of an ES (Annex to SDS)
 

Example 1: ES for the fictional substance “Diisocyanate X”
 

Substance name: Diisocyanate X
CAS number: 1234-56-7
Version number and date: 12.09.2022, v.1

Contents

• ES 1: Widespread Use by Professional Workers; Adhesives, Sealants (PC 1); small scale application of adhesives, sealants or primers
• ES 2: Widespread Use by Professional Workers; Adhesives, Sealants (PC 1); large scale application of 2- or multi-component reactive adhesives

Sections 3 and 4
Please see Example 1, ES 1.

Example 2: ES for the fictional substance “Triamine X”
 

Substance name: Triamine X 
CAS number: 2345-67-8
Version number and date: 12.09.2022, v.1

List of abbreviations
See example 1

Sections 3 and 4
Please see Example 1, ES 1.

Appendix IIb: Bilaga till del 3 av enkäten

Enkät om exponeringsscenarier i säkerhetsdatablad:

Innehåll

• Förslag om minimiinnehåll i exponeringsscenarier (som bilaga til SDS)

• Exempel 1: ES för det fiktiva ämnet “Diisocyanat X”

• Exempel 2: ES för det fiktiva ämnet “Triamin X”

I detta bilaga hittar ni ett förslag om vilken information et exponeringsscenario (ES) åtminstone borde innehålla, och två praktiska exemplar. Enkätens del 3 har några frågor till detta.

Båda exemplerna representerar bilagar till ett SDS. 
I exempel 1 finns två exponeringsscenarier, i exempel 2 finns ett exponeringsscenario.

Obs! Formatet till exponeringsscenarierna är inte viktig i denna enkäten. Vänligen fokusera på innehåll, inte på presentation/format.

INFORMATION OM ENKÄTEN

Målet med denna undersökningen är att samla erfarenheter och åsikter från er som är (eller kan bli) mottagare av säkerhetsdatablad med exponeringsscenarier. Era svar kommer att ge oss en bild av vad som fungerar och inte fungerar, och vad som är viktigt att exponeringsscenarier innehåller. Med andra ord har ni chansen att påverka nu! 

Vad gör vi med svaren? Vi på Kiwa Kompetanse uppsummerar svaren i en rapport, som vi sände vi till Nordisk arbetsgrupp för kemikalier (en grupp under Nordiska ministerrådet, med representanter från kemikaliemyndigheterna i de nordiska länderna). Det är de som har startat detta projekt. De vill ha input från er ute i verksamheterna, så att de får ett bra underlag att jobba vidare med exponeringsscenarier - bl.a. att överväga ett mer standardiserat eller gemensamt krav på innehåll.

Vi vill gärna höra vad ni tycker! Här finns det inga rätta eller fel svar, vi önskar en så ärlig bild som möjligt.
 

Undersökningen är uppdelad i 3 delar, och tar upp till 20 min. beroende på hur detaljerat ni själva väljer att svara.

• Del 1: allmänna frågor om er verksamhet
• Del 2: erfarenheter av säkerhetsdatablad och exponeringsscenarier
• Del 3: frågor kring förslaget om minimiinnehåll i ett exponeringsscenario (detta bilaga)
 

Undersökningen är anonym. Svaren kopplas inte till enskilda personer eller verksamheter. 

Sista svarsdag är onsdag 5. oktober. 

Frågor om undersökningen? Kontakta Solveig Aamodt: solveig.aamodt@kiwa.com   

Tusen tack - ditt bidrag är värdefullt!

Förslag om minimiinnehåll i exponeringsscenarier (som bilaga til SDS)

Exempel 1: ES för det fiktiva ämnet “Diisocyanat X”
 

Ämnesnamn: Diisocyanat X
CAS-nummer: 1234-56-7
Versionsnummer och datum: 12.09.2022, v.1

Innehåll​

• ES 1: Vitt spridd yrkesmässig använding; Lim, tätningsmedel (PC 1); småskalig använding av lim eller tätningsmedel
• ES 2: Vitt spridd yrkesmässig bruk; Lim, tätningsmedel (PC 1); storskalig använding av 2- eller multikomponent reaktivt lim

Avsnitt 3 och 4
Vänligen se exempel 1, ES 1.

Exempel 2: ES för det fiktiva ämnet “Triamin X”

Ämnesnamn: Triamin X 
CAS-nummer: 2345-67-8
Versionsnummer och datum: 12.09.2022, v.1

Förkortningar
Se lista i exempel 1

Avsnitt 3 och 4
Vänligen se exempel 1, ES 1.

Appendix IIc: Vedlegg til del 3 av spørreundersøkelsen

Spørreundersøkelse om eksponeringsscenarier i sikkerhetsdatablader:

Innhold

• Forslag til minimumsinnhold i eksponeringsscenarier (vedlegg til SDS)

• Eksempel 1: ES for det fiktive stoffet “Diisocyanat X”

• Eksempel 2: ES for det fiktive stoffet “Triamin X”

I dette vedlegget finner du et forslag til hvilken informasjon et eksponeringsscenario (ES) minst bør inneholde, og to eksempler på hvordan dette kan se ut. Spørreundersøkelsens del 3 har noen spørsmål knyttet til dette.

Begge eksemplene representerer vedlegg til et SDS. 
I eksempel 1 er det to eksponeringsscenarier, i eksempel 2 er det ett eksponeringsscenarie.

Obs! Format/utseende på eksponeringsscenarier er ikke en viktig del av undersøkelsen. Vi ber dere derfor om å fokusere på innholdet først og fremst, ikke hvordan det er presentert og ser ut.

GENERELL INFO OM SPØRREUNDERSØKELSEN

Målet med denne undersøkelsen er å samle erfaringer og meninger fra dere som er (eller kan bli) mottakere av sikkerhetsdatablader med eksponeringsscenarier. Deres svar vil gi oss et bilde av hva som fungerer og ikke fungerer, og hva det er viktig at eksponeringsscenarier inneholder. Dere har sjansen til å påvirke nå! 

Hva gjør vi med svarene? Vi i Kiwa Kompetanse gjennomgår alle svarene og oppsummerer dem i en rapport. Rapporten sender vi til Nordisk arbeidsgruppe for kjemikalier (en gruppe under Nordisk ministerråd, med representanter fra kjemikaliemyndighetene i de nordiske landene). Det er de som har satt i gang dette prosjektet. De ønsker innspill fra dere i virksomhetene, slik at de har et godt grunnlag for å jobbe videre med eksponeringsscenarier - bl.a. å vurdere mer standardisering eller felles krav til innhold.

Vi vil gjerne høre hva dere mener! Her er ingenting riktig eller galt, vi ønsker et så ærlig bilde som mulig.

Undersøkelsen er delt i 3, og vil ta ca. 20-30 min. avhengig av hvor detaljert dere selv ønsker å svare.

Del 1: helt generelle spørsmål om virksomheten
Del 2: erfaring med sikkerhetsdatablader og eksponeringsscenarier
Del 3: spørsmål til forslaget om minimumsinnhold i eksponeringsscenarier

Undersøkelsen er anonym. Besvarelsene kobles ikke til enkeltpersoner eller virksomheter. 

Frist for besvarelser er onsdag 5. oktober. 

Spørsmål om undersøkelsen? Kontakt Solveig Aamodt i Kiwa Kompetanse: solveig.aamodt@kiwa.com 
  
Tusen takk – ditt bidrag er verdifullt!

Forslag til minimumsinnhold i eksponeringsscenarier (vedlegg til SDS)

Eksempel 1: ES for det fiktive stoffet “Diisocyanat X”

Stoffnavn: Diisocyanat X
CAS-nummer: 1234-56-7
Versjonsnummer og dato: 12.09.2022, v.1

Innhold​

• ES 1: Utstrakt profesjonell bruk; Lim, fugemasse (PC 1); småskala påføring av lim, fugemasse eller primere
• ES 2: Utstrakt profesjonell bruk; Lim, fugemasse (PC 1); storskala påføring av 2- eller multikomponent reaktivt lim

3 og 4
Vennligst se eksempel 1, ES 1.

Eksempel 2: ES for det fiktive stoffet “Triamin X”

Stoffnavn: Triamin X 
CAS-nummer: 2345-67-8
Versjonsnummer og dato: 12.09.2022, v.1

Forkortelser​
Tilsvarende liste som i eksempel 1 

3 og 4
Vennligst se eksempel 1, ES 1.

Appendix IId: Vedlæg til del 3 af spørreundersøgelsen

Spørreundersøgelse om eksponeringsscenarier i sikkerhedsdatablader:

Innhold​

• Forslag til minimumsindhold i eksponeringsscenarier (vedlegg til SDS)

• Eksempel 1: ES for det fiktive stof “Diisocyanat X”

• Eksempel 2: ES for det fiktive stof “Triamin X”

I dette vedlæg finder du et forslag til, hvilke oplysninger et eksponeringsscenario (ES) som minimum bør indeholde, og to praktiske eksempler. I spørreundersøgelsens del 3 finder du nogle relaterede spørgsmål.

Begge eksempler representerer vedlæg til et SDS. 
Eksempel 1 indeholder to eksponeringsscenarier, eksempel 2 indeholder ett eksponeringsscenarie.

Obs! Format/udseende på eksponeringsscenarier er ikke fokus for undersøkelsen. Vi beder dig derfor primært fokusere på indholdet, ikke hvordan det præsenteres og ser ud.

GENERELT OM UNDERSØGELSEN

Formålet med undersøgelsen er at indsamle viden fra virksomheder der er (eller kan blive) modtagere af sikkerhedsdatablade med eksponeringsscenarier. Vi vil vide hvad der fungerer, hvad der ikke fungerer, og hvad det er vigtigt for jer, at eksponeringsscenarier indeholder. Du har chancen for at påvirke nu!

Hvad gør vi så med svarene? Vi i Kiwa Kompetanse gennemgår alle svar, og sammenfatter alt i en rapport. Rapporten sender vi til arbejdsgruppen for kemikalier, miljø og sundhed under Nordisk ministerråd, hvor der er repræsentanter fra kemikaliemyndighederne i de nordiske land. De vil gerne have input fra virksomhederne, så de får et godt grundlag for at arbejde videre med eksponeringsscenarier – bland annet at vurdere mere standardisering eller fælles krav til indhold.

Vi vil gerne høre hvad I mener! Her findes ingen rigtige eller forkerte svar – ærlige svar er mest nyttige!

Undersøgelsen er delt i 3, og tager op til 20 minutter.

Undersøgelsen er anonym. Besvarelserne knyttes ikke til enkeltpersoner eller virksomheder. 

Svarfristen er onsdag den 5. oktober. 

Spørgsmål til undersøgelsen? Kontakt Solveig Aamodt i Kiwa Kompetanse: solveig.aamodt@kiwa.com 
  
Mange tak – dit bidrag er værdifuldt!

Forslag til minimumsindhold i eksponeringsscenarier (vedlegg til SDS)

Eksempel 1: ES for det fiktive stof “Diisocyanat X”

Stofnavn: Diisocyanat X
CAS-nummer: 1234-56-7
Versionsnummer og dato: 12.09.2022, v.1

Innhold

• ES 1: Vidt udbredt erhvervsmæssig anvendelse; Klæbestoffer, tætningsmidler (PC 1); småskala påføring af klæbestoffer, tætningsmidler eller primere
• ES 2: Vidt udbredt erhvervsmæssig anvendelse; Klæbestoffer, tætningsmidler (PC 1); storskala påføring af 2- eller multikomponent reaktive klæbemidler

3 og 4
Se venligst eksempel 1, ES 1.

Eksempel 2: ES for det fiktive stof “Triamin X”
 

Stofnavn: Triamin X 
CAS-nummer: 2345-67-8
Versionsnummer og dato: 12.09.2022, v.1

Forkortelser
Liste som i eksempel 1

3 og 4
Se venligst eksempel 1, ES 1.

About this publication

Identification and assessment of exposure scenario minimum requirements

Solveig Aamodt; Ottar Madslien. Kiwa Kompetanse AS, Project Consultants

ISBN 978-92-893-7503-0 (PDF)
ISBN 978-92-893-7504-7 (ONLINE)
http://dx.doi.org/10.6027/temanord2022-567

TemaNord 2022:567 
ISSN 0908-6692

© Nordic Council of Ministers 2022

Cover photo: wal_172619/pixabay

Published: 18/1/2023

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