Report 8/18 - Survey of hazardous chemical substances in ... · Feminine hygiene products such as...

Survey of hazardous chemical substances in feminine hygiene products A study within the government assignment on mapping hazardous chemical substances 2017–2020

REPORT 8/18

kemikalieinspektionen.se

The Swedish Chemicals Agency is supervisory authority under the Government. We work in Sweden, the EU and internationally to develop legislation and other incentives to promote good health and improved environment. We monitor compliance of applicable rules on chemical products, pesticides and substances in articles and carry out inspections. We review and authorise pesticides before they can be used. Our environmental quality objective is A Non-toxic Environment. © Swedish Chemicals Agency. Stockholm 2018.

Article number: 361 308.

Preface The Government has commissioned the Swedish Chemicals Agency1 to conduct a survey of the presence of hazardous chemical substances in products and articles that are not yet restricted within the EU. The commission spans four years and a final report shall be made in December 2020.

Within this government commission, the Swedish Chemicals Agency has defined a number of sub-assignments.

This report summarises the results of one of the sub-assignments: a survey of hazardous chemical substances in feminine hygiene products on the Swedish market.

The survey was conducted as a literature study and a screening analysis, with the purpose to achieve unbiased identification of chemical substances in a product. The screening analysis was conducted by IVL Swedish Environmental Research Institute. Quantitative analyses were then performed with the aim of measuring the concentrations of known chemicals in the analysed products. The quantitative analyses were performed by Eurofins Environment Testing Sweden AB. Thereafter, the Swedish Chemicals Agency has performed a risk assessment.

The Chemicals Agency’s project managers for this report were Amanda Rosen, Margareta Daho and Ulrika Dahl. The project manager responsible for the overall survey project was Erik Gravenfors. The health risk assessment was performed by Charlotte Bergkvist, Anna-Karin Mörk, Ilona Silins, Alexandra Stewart and Margareta Warholm.

1 Appropriation Directions for the financial year 2017, Swedish Chemicals Agency.

Innehåll Glossary ............................................................................................................ 5

Sammanfattning ............................................................................................... 7

Summary ........................................................................................................... 8

1 Why we are investigating feminine hygiene products ...................... 9 1.1 Current legislation ........................................................................................................... 9 1.2 Feminine hygiene products with “odour control” ........................................................... 10 1.3 Argentinian study on glyphosate gained attention ........................................................ 11

2 How we conducted our investigation ............................................... 11 2.1 Dialogue with industries and companies ....................................................................... 12 2.2 Scope and limitations .................................................................................................... 12 2.3 Products for screening analysis and quantitative analysis ........................................... 13 2.4 Literature study and screening analysis ........................................................................ 19 2.5 Quantitative analyses of substances based on IVL’s investigation .............................. 19 2.6 Health risk assessment of substances found in quantitative analyses ......................... 20

3 Results of our analysis....................................................................... 21 3.1 Common areas of application for substances we found in feminine hygiene products 22

4 Health risk assessment of chemical substances in feminine hygiene products ............................................................................... 24

4.1 In order to assess the health risk, we require information regarding the chemical substance’s hazardous properties ................................................................................ 24

4.2 In order to assess the health risk, we need to calculate the exposure to the chemical substance ...................................................................................................................... 25

4.3 The risk characterisation ratio (RCR) indicates whether or not the risk of negative health effects is controlled............................................................................................. 25

4.3.1 How to interpret risk characterisation ratios .................................................................. 26 4.3.2 Calculations of the health risk based on modified reference values ............................. 26 4.4 No health risk assessment for three chemical substances ........................................... 32

5 Discussion and conclusions ............................................................. 33 The Chemicals Agency’s assessment – low health risk .............................................................. 34 Moving on – alerting companies to problematic substances ....................................................... 34

Appendix 1. Method ....................................................................................... 35 Product samples – selection, purchase and transportation ........................................................ 35

Appendix 2. Results ....................................................................................... 40 Sanitary towels ............................................................................................................................ 40 Panty liners .................................................................................................................................. 42 Tampons ...................................................................................................................................... 45 Menstrual cups ............................................................................................................................ 47

Appendix 3. IVL´s report …………………………………………………………..49

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Glossary AMPA Decomposition product of glyphosate (see glyphosate).

Biocide/biocidal products Chemical or biological pesticides produced in order to prevent or counteract animals, plants or microorganisms, including viruses, from causing harm or detriment to human health or damage to property.

Assessment factors Used to manage uncertainty and variation when producing a reference value, e.g., in order to handle differences between animals and humans when the results of animal experiments are used as a basis (also referred to as uncertainty factors, safety factors)

Dioxins Group of substances, very persistent and potent environmental toxins.

ECHA European Chemicals Agency.

EFSA European Food Safety Authority.

Eurofins Eurofins Environment Testing Sweden AB

Exposure How much (concentration or quantity) of a substance a person is exposed to over a defined period.

Hazard Inherent properties of a substance which can entail negative effects on health and the environment.

Hazardous chemical substances When we use the expression “hazardous chemical substances” in this report, it includes both the chemical substances assessed to be hazardous and the substances suspected to be hazardous, based on the criteria for classification of hazardous substances within the EU.

Glyphosate An active substance in plant protection products used primarily for weed control on agricultural land in the spring before the crops’ growth and in the autumn after harvest.

IVL Swedish Environmental Research Institute

The Environmental Research Institute, owned by the Foundation for IVL Swedish Environmental Research Institute (SIVL). Works with applied research and consultancy assignments in environmental and sustainability issues.

Classification Classifying a chemical substance or mixture entails identifying its hazardous properties.

Qualitative chemical analysis Analysis which identifies chemical substances without providing exact information on concentrations.

Quantitative chemical analysis Analysis intended to identify and quantify (determine the concentration of) a chemical substance.

Migration The process whereby a substance leaks, i.e. migrates, from a material to the surroundings.

Mutagenic substance Substance which damages genetic material.

Nonwoven fabric Textile material consisting of thin fibres which have no interlinking structure, unlike woven or knitted fabrics.

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Reporting limit The lowest concentration of a substance that can be measured with reasonable statistical certainty in the current chemical analysis.

REACH regulation European chemical legislation. Registration, Evaluation, Authorisation and Restriction of Chemicals.

Reprotoxic substance Substance that harms reproductive capacity.

Reference value A concentration of a substance that should not be exceeded, in order to avoid the risk of negative effects on health or environment.

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Sammanfattning Kemikalieinspektionen verkar för att kemiska ämnen med särskilt farliga egenskaper ska fasas ut ur produkter och varor som är tillgängliga för allmänheten. Detta är en del i det övergripande arbetet med riksdagens miljökvalitetsmål Giftfri miljö samt inom ramen för regeringens uppdrag om en handlingsplan för en giftfri vardag.

Intimhygienprodukter såsom bindor, trosskydd, tamponger och menskoppar, används regelbundet av stora delar av befolkningen och Kemikalieinspektionen har ansvar för tillsynen av dessa produkter. Vi har därför genomfört en kartläggning av farliga kemiska ämnen i intimhygienprodukter på den svenska marknaden. Undersökningen är en del av regeringsuppdraget att kartlägga farliga kemiska ämnen i produkter och varor som är tillgängliga för allmänheten. När vi i den här rapporten använder uttrycket ”farliga kemiska ämnen”, inkluderar det både kemiska ämnen som är bedömda som farliga samt ämnen som misstänks vara farliga, baserat på kriterierna för klassificering av farliga ämnen inom EU.

I vår kartläggning har vi genomfört litteraturstudier samt kvalitativa och kvantitativa kemiska analyser av 35 olika intimhygienprodukter. Detta betyder att vi har undersökt vilka farliga kemiska ämnen som förekommer i produkterna samt i vilka halter. I undersökningen analyserade vi förekomsten av 62 olika farliga kemiska ämnen. Av dessa fann vi att totalt 21 farliga kemiska ämnen förekommer i huvudsakligen låga halter och inget av ämnena är förbjudna i den här typen av varor. Med låga halter menar vi i denna rapport halter som är lägre än 0,1 viktprocent. Ett av ämnena hittades i 0,2 viktprocent i en av menskopparna.

Totalt sett innebär detta att 41 av ämnena inte återfanns alls i de analyserade intimhygienprodukterna i halter över rapporteringsgränsen.

Vi utförde en översiktlig riskbedömning för 18 av de 21 ämnena. För de resterande tre ämnena finns det i dag inte tillräckliga toxikologiska data för att vi ska kunna utföra en riskbedömning. Kemikalieinspektionen bedömer att risken för negativa hälsoeffekter från exponering för kemiska ämnen i intimhygienprodukter är låg för de 18 ämnen vi kunnat riskbedöma. Detta betyder att vi bedömer att man kan fortsätta använda dessa intimhygienprodukter utan att oroa sig för sin hälsa. De tre ämnena som vi inte kunde riskbedöma hittades i vissa menskoppar. Dock var halterna av dessa ämnen i menskopparna låga och det finns heller ingen information som tyder på att de utgör en risk.

I våra analyser av kemiska ämnen hittade vi inga rester av glyfosat eller dess nedbrytningsprodukt AMPA över rapporteringsgränsen, det vill säga den lägsta halten av ett ämne som kan mätas med rimlig statistisk säkerhet i den kemiska analysen.

När det gäller de tre ämnen vi inte kunnat riskbedöma kommer vi inom Kemikalieinspektionens övergripande kartläggningsarbete och inom ramen för regeringsuppdraget om Giftfri vardag, genom dialog med de tillverkande företagen och importörerna att uppmärksamma dem på analysresultaten i den här rapporten. Vi tar även med oss ämnena in i kartläggningsarbetet för att framöver vidare bedöma om det är kemiska ämnen som vi i en framtid anser bör åtgärdas eller inte.

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Summary The Swedish Chemicals Agency works to promote the phasing out of chemical substances with particularly hazardous properties from products and articles that are available to the general public. This is part of our overall work relating to the Government’s environmental quality objective of a Non-Toxic Environment and within the Government’s assignment for an action plan for a non-toxic everyday environment.

Feminine hygiene products such as sanitary towels, panty liners, tampons and menstrual cups are used regularly by large parts of the population, and the Swedish Chemicals Agency is responsible for the regulation of these products. We have therefore conducted a survey of hazardous chemical substances in feminine hygiene products. The survey is part of the Government’s assignment to survey hazardous chemical substances in products and articles that are available to the general public. When we use the expression “hazardous chemical substances” in this report, this includes both the chemical substances assessed to be hazardous and the substances suspected to be hazardous, based on the criteria for classification of hazardous substances within the EU.

In our survey we conducted studies of literature and qualitative and quantitative chemical analyses of 35 different feminine hygiene products. This means that we studied what hazardous chemical substances the products contain and in what concentrations. We analysed a total of 62 chemical substances. Among these, we found 21 hazardous chemical substances, mainly in low concentrations, and none of the substances are prohibited in these types of products. When we speak of low concentrations in this report, we mean concentrations of less than 0.1 per cent weight by weight. In one of the menstrual cups, one of the substances was found at a concentration of 0.2 per cent weight by weight. Altogether, this means that in the feminine hygiene products that we analysed, 41 of the substances were not found in concentrations above the reporting limit.

We carried out health risk assessments for 18 of the substances. For three of the substances, there is currently insufficient toxicological data available to conduct a health risk assessment. In the Swedish Chemicals Agency’s judgement, the risk of negative health effects from exposure to chemical substances in feminine hygiene products is low for the 18 products for which we were able to conduct a health risk assessment. We therefore conclude that people can continue to use these feminine hygiene products without worrying about their health. The three substances for which we could not conduct a health risk assessment were found in some of the menstrual cups. However, the concentrations of these substances in the menstrual cups were low. Furthermore, there is no information to indicate that these substances constitute a health risk.

In our analysis of chemical substances, we found no residues of glyphosate or its degradation product AMPA above the reporting limit, i.e. the lowest concentration that can be measured with statistical certainty in the chemical analysis.

As part of our overall survey work and within the framework of our governmental assignment concerning a non-toxic everyday environment, we will make manufacturing companies and importers aware of the findings in this report as regards the three substances for which we could not conduct a health risk assessment. We will also include the substances in the survey in order to assess whether they are chemical substances that the Swedish Chemicals Agency will consider for further measures in future.

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1 Why we are investigating feminine hygiene products

The Swedish Chemicals Agency works to promote the phasing out of chemical substances with particularly hazardous properties from products and articles that are available to the general public. This is part of our overall work relating to the Government’s environmental quality objective of a Non-Toxic Environment and falls within the Government’s assignment to produce an action plan for a non-toxic everyday environment. The Swedish Chemicals Agency also has an ongoing government commission with the purpose of surveying hazardous substances during the period 2017–2020.

Our government commission in accordance with the appropriation directions for 2017:

The Swedish Chemicals Agency shall conduct a survey of the presence of hazardous chemical substances in mixtures and articles that are not yet restricted within the EU. The survey will primarily focus on substances of very high concern, but it may also cover hazardous substances where relevant to the protection of human health and the environment. Children and young people are a priority and an equality perspective shall be adopted. In particular, the presence of these substances in articles and mixtures available to consumers shall be surveyed.

Within the scope of the government-commissioned survey of hazardous substances 2017–2020, the Swedish Chemicals Agency has investigated feminine hygiene products such as sanitary towels, tampons, panty liners and menstrual cups on the Swedish market. The aim has been to check whether they contain hazardous chemical substances and can thereby entail a risk to health when used. When we use the expression “hazardous chemical substances” in this report, this includes both the chemical substances assessed to be hazardous and the substances suspected to be hazardous, based on the criteria for classification of hazardous substances within the EU. We have made the assessment that it is important to investigate menstrual hygiene products and other feminine hygiene products, as such a large proportion of the Swedish population regularly uses these types of products, which come into direct contact with the body for much of the individual’s life.

1.1 Current legislation There is currently no Swedish legislation or EU legal instrument which deals specifically with the product type “feminine hygiene products”. The chemical substance contents of such products are therefore regulated by general regulations on chemical substances in articles. On the EU level, we have the REACH regulation2 which, among other things, contains provisions on limitations of certain substances. There are two restrictions where this product type is mentioned specifically. In accordance with one of the restrictions, dioctyl tin (DOT) may not be used in “female hygiene products” if the concentration of tin is higher than 0.1 per cent weight by weight.3 The other restriction relates to the use of azo dyes in products such as “nappies and hygiene articles”. These are examples of articles which can come into direct and long-term contact with the skin and which therefore may not contain azo dyes, which can give off the aromatic amines listed in supplement 8 to the appendix.4

2 Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency 3 Item 20 annex XVII of REACH. 4 Item 43 annex XVII of REACH.

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Sweden also has the Product Safety Act, which is intended to ensure that products and services for consumers do not cause personal injury. The act can only be applied when the risks are not covered by special safety requirements in other legislation. Products provided to consumers must be safe. In accordance with the Product Safety Act, products are safe if, in normal or reasonably predictable use and lifespan, they do not entail a risk to people’s health and safety or if they only entail a low risk5.

In accordance with Article 33 of REACH, consumers have the right to receive information if an article contains 0.1 per cent weight by weight or more of a substance included on the “Candidate List”. The information must be disclosed upon request and within 45 days. A retailer shall receive the information directly from suppliers within the EU without needing to ask for it. The Candidate List is a list of substances considered particularly hazardous, referred to as SVHC substances (Substances of Very High Concern). These are for example substances which can cause cancer, affect the ability to have children or damage the environment. The European Chemicals Agency (ECHA) updates the list with new substances twice per year.

The information obligation in accordance with Article 33 applies to all articles that fulfil the definition in the legislation, including feminine hygiene products such as sanitary towels and panty liners.

Feminine hygiene products are not classed as medical devices and are therefore not covered by the same requirements imposed on e.g., condoms and plasters. This is because they do not fit the definition in Section 2 of the Medical Devices Act (1993:584):

A medical device is considered by law to be a product which in accordance with the manufacturer’s information is intended to be used on people, whether separately or in combination with something else, in order to

1. detect, prevent, monitor, treat or mitigate a disease, 2. detect, monitor, treat, mitigate or compensate for an injury or disability, 3. investigate, change or replace parts of the anatomy or a physiological process, or 4. control fertilisation.

1.2 Feminine hygiene products with “odour control” Over the past five years, the Swedish Chemicals Agency has started around ten inspection cases concerning feminine hygiene products. The majority concerned products with a strong scent or “odour control”.

Two cases concerned consumers having physical symptoms due to use (burning, itching, asthma-like symptoms). The rest were matters concerning whether or not it is permitted or appropriate to scent these types of articles. In 2015, we initiated an inspection case against a company responsible for articles which had given rise to symptoms. The company provided data, such as clinical studies, and the Swedish Chemicals Agency’s assessment based on the documentation was that the company had done what it could to show that the products were safe and no further action was therefore taken in the case.

In autumn 2015, the Finnish Safety and Chemicals Agency (Tukes) received more than 20 reports concerning sanitary towels with “odour control” which were scented with an odorant and concerning skin symptoms which these were suspected to have caused. Consumers described symptoms in the form of allergic skin reactions, irritation, boils and sores in the 5 Sections 1 and 7–8 of the Product Safety Act.

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genital area and asthma attacks. This is an unusually large number of reports regarding a single product.

Tukes communicated with the companies that released the products in question on the Finnish market but found no support in legislation to impose requirements regarding measures, such as marking the products with the name of the substances used as odorants.

1.3 Argentinian study on glyphosate gained attention In autumn 2015, Damián Marino, an Argentinian researcher in environmental medicine at Universidad Nacional de La Plata, presented the results of measurements of the substance glyphosate in tampons, sanitary towels and other hygiene products made from cotton and/or rayon (viscose).6 Glyphosate is found for example in Roundup, one of the world’s best-selling weed killers. The results showed that 85 per cent of the tested products contained glyphosate and 62 per cent contained AMPA7, a decomposition product of glyphosate. The concentrations quoted in articles in the media concerning the study were very low: 39 µg/kg for AMPA and 13–17 µg/kg for glyphosate (corresponding to 0.0000039 and 0.0000013–0.0000017 per cent weight by weight respectively).8

The information on glyphosate in tampons gained wide international dissemination and gave rise to a debate on the risks of hazardous chemical substances in feminine hygiene products in Sweden. For this reason, the public, consumer organisations and politicians alike demanded an investigation of the chemicals in menstrual hygiene products and other feminine hygiene products which are used regularly for a large part of many people’s lives and which also come into direct contact with mucous membranes in the genital area.

2 How we conducted our investigation The investigation was conducted in two parts: 1) literature studies and screening analyses9 performed by IVL Swedish Environmental Research Institute, and 2) quantitative analyses10 performed by Eurofins Environment Testing Sweden AB. The measured concentrations have then been used as the basis for an assessment of the risk of negative health effects from exposure to these substances.

Methods for unbiased screening analyses provide the opportunity to find chemical substances in products without first having to determine exactly which substances we want to look for. This represents a major difference from the more traditional quantitative analyses which are more commonly used and where the methodology limits the results in such a way that it is only possible to receive information concerning chemicals already suspected to be present in the product.

6 Environmental Impact of Glyphosate use in Argentina, https://ensser.org/wp- content/uploads/2017/09/Mex16.MARINO-_Mexico_dic2016-.pdf 7 (Aminomethyl)phosphonic acid. 8 Universidad Nacional de La Plata. (2015). Encuentran glifosato en algodón, gasas, hisopos, toallitas y tampones. Obtained on 18/06/2018 from http://www.exactas.unlp.edu.ar/articulo/2015/10/21/encuentran_glifosato_en_algodon__gasas__hisopos__toallitas_y_tampones 9 Screening analyses are intended to achieve unbiased identification of chemical substances in a product. For a detailed description of screening analyses, see IVL’s final report. (Appendix 2). 10 Quantitative analyses are intended to measure concentrations of known chemicals in analysed products.

https://ensser.org/wp-%20content/uploads/2017/09/Mex16.MARINO-_Mexico_dic2016-.pdf

https://ensser.org/wp-%20content/uploads/2017/09/Mex16.MARINO-_Mexico_dic2016-.pdf

http://www.exactas.unlp.edu.ar/articulo/2015/10/21/encuentran_glifosato_en_algodon__gasas__hisopos__toallitas_y_tampones

http://www.exactas.unlp.edu.ar/articulo/2015/10/21/encuentran_glifosato_en_algodon__gasas__hisopos__toallitas_y_tampones

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The screening analysis provides us with information on a broader spectrum of which chemical substances can be found in a product, though not their concentrations. In order to find out their concentrations, it is therefore necessary to proceed with the quantitative analyses.

Figure 1. Primary steps for the Swedish Chemicals Agency’s performance of the investigation of feminine hygiene products

A) Feminine hygiene products on the Swedish market acquired for B) a survey of the chemical contents through screening analysis and literature studies. C) Chemical substances of interest were selected for D) additional testing in the laboratory where the quantitative analyses were performed in order to determine whether any of the chemical substances of interest were found in the feminine hygiene products, and what their concentrations were. If they were found, a health risk assessment was performed based on existing information.

In sections 2.3, 2.4, 2.5 and 2.6 we discuss in more detail the implementation of the different parts of the project. More details about the method can also be found in Appendix 1.

2.1 Dialogue with industries and companies In order to increase our knowledge of the products and their composition, the Swedish Chemicals Agency has had meetings and communications with the trade association EDANA, which represents companies in the nonwoven industry. We have also communicated with individual representatives of the feminine hygiene product industry.

2.2 Scope and limitations When we use the expression “hazardous chemical substances” in this report, this includes both the chemical substances assessed to be hazardous and the substances suspected to be hazardous, based on the criteria for classification of hazardous substances within the EU.

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In this project, we have chosen to use the term feminine hygiene products in order to include – in addition to menstrual hygiene products such as sanitary towels, tampons and menstrual cups – products which are also used outside of the menstrual period, such as panty liners and incontinence products. All of these products fall under the Swedish Chemicals Agency’s supervisory remit and we have chosen to focus solely on these, despite the fact that the government commission also has room for investigations into other agencies’ areas of responsibility, including cosmetic and hygienic products such as soap and skin cream for use in the genital area11. Read more about our method for product selection in appendix 1.

Apart from sanitary towels, panty liners and tampons, we also chose to investigate menstrual cups12. The market for these is increasing, and as the use of menstrual cups increases, more brands are appearing on the Swedish market.

This survey does not include an assessment regarding the risk of toxic shock syndrome (TSS)13 or other symptoms caused by anything other than the chemical contents of the products as such problems are not within the remit of the Swedish Chemicals Agency.

2.3 Products for screening analysis and quantitative analysis

Table 1. Sanitary towels

Sample name Product name

Brand Store Other Image

Sanitary towel 1 Ultra Thin Goodnight Wings

Libresse ICA Overnight pad

Sanitary towel 2 TENA Lady Extra

TENA ICA Incontinence pad

Sanitary towel 3 ICA Basic Normal

ICA ICA

11 This type of feminine hygiene product falls under the Swedish Medical Products Agency’s enforcement area. 12 The majority is manufactured in a silicon material, but other polymeric materials are used, such as thermoplastic elastomers (TPE). 13 Toxic Shock Syndrome (TSS), is a complication which may arise as a result of certain bacterial infections. A toxin secreted by the bacteria causes a drastic drop in blood pressure and the body’s tissues do not receive enough oxygen.

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Sample name Product name

Brand Store Other Image

Sanitary towel 4 Hjärtats bindor med vingar Maxi

Hjärtats Apotek Hjärtat

Sanitary towel 5 ALWAYS Ultra Night (Size 3) sanitary towels with wings

Always ICA Overnight pad

Sanitary towel 6 Siempre Ultra Plus with wings - Normal

Siempre Lidl “With aloe vera”

Sanitary towel 7 Binda Naturesoft Super Day - Wings

Naturesoft City Gross

Table 2. Panty liners

Sample name

Product name Brand Store Other Image

Panty liner 1 Libresse Dailyfresh Normal Deo Fresh

Libresse ICA “Mildly scented”

Panty liner 2 Natracare Panty Liner Curved (organic)

Natracare ICA With organic

cotton carrying the

Nordic Swan

Ecolabel

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Sample name


Panty liner 3 ALWAYS

DAILIES Extra Protect Large Panty Liners

Always ICA “100% odour protection”

Panty liner 4 Always Fresh & Protect Normal

Always ICA “Fresh Scent”

Panty liner 5 Tena Lady Mini Magic

Tena ICA “Fresh Odour Control”

Panty liner 6 ICA Trosskydd Normal

ICA ICA

Panty liner 7 Apoliva Normalt Trosskydd

Apoliva Apoteket

Panty liner 8 Coop Xtra Normal Trosskydd

Coop Coop

Panty liner 9 Änglamark Trosskydd Normal

Änglamark Coop Carries the Nordic Swan Ecolabel

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Sample name


Panty liner 10

Caroli Caroli Järva Gross

Table 3. Tampons

Sample name


Tampon 1 Tampax Super Tampax ICA

Tampon 2 ICA Basic Normal

ICA Basic ICA

Tampon 3 ICA Normal Miljömärkt

ICA ICA Carries the Nordic Swan Ecolabel

Tampon 4 o.b. ProComfort Night Super

o.b. ICA

Tampon 5 Natracare Organic Super Cotton Tampons

Natracare ICA Organic cotton

Tampon 6 Renée Voltaire Lingonvecka Super Plus

Lingonvecka

ICA Organic cotton

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Sample name


Tampon 7 Libresse Discreet Super

Libresse ICA

Tampon 8 Coop Super Plus Coop Coop Carries the Nordic Swan Ecolabel

Tampon 9 Intuition Super Intuition Willys Carries the Nordic Swan Ecolabel

Tampon 10 Sence Sence Ö&B

Table 4. Menstrual cups

Sample name


Menstrual cup 1

OrganiCup menskopp Stl B

OrganiCup Apotea.se

Silicon

Manufactured in

China

Menstrual cup 2

Lunette Menskopp Klar size 2

Lunette Apotea.se

Silicon

Manufactured in Finland

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Sample name


Menstrual cup 3

Me Luna Menskopp Soft size large (turquoise)

Me Luna M-koppen.se

Thermoplastic elastomer

Manufactured in Germany

Menstrual cup 4

Svenska Menskoppen – Medium

Svenska Menskoppen

Menskoppen.se


Manufactured in Sweden

Menstrual cup 5

Mooncup menskopp model A

Mooncup Apotea.se

Silicon

Manufactured in the United Kingdom

Menstrual cup 6

MonthlyCup menskopp size 2

MonthlyCup

Apotea.se

Silicon

Manufactured in Sweden

Menstrual cup 7

Menskopp Wcup in silicon

Wcup Fyndiq Silicon

Manufacturing country unclear

Marked in Chinese

Menstrual cup 8

The DivaCup Model 2

The DivaCup

Jordklok.se

Silicon

Manufactured in Canada

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2.4 Literature study and screening analysis IVL Swedish Environmental Research Institute was commissioned to conduct a literature study and screening analysis (qualitative chemical analysis) of the presence of chemical substances in 35 different feminine hygiene products. On this basis, IVL was then to recommend chemicals for quantitative chemical analysis. In this section, we provide a short summary of this work. For further information, refer to IVL’s report in appendix 2. For information regarding the sample tests, see tables 1–4 in section 2.3. For details on the selection of products and purchasing, see appendix 1.

The literature study included a review of articles in scientific literature, consumer tests and surveys performed by other authorities, interest groups or consumer organisations in Sweden and abroad, and environmental labelling criteria for feminine hygiene products.

During the screening, the samples were analysed using a combination of liquid chromatography and mass spectrometry14. The results of the analysis were then interpreted with the help of databases containing substances viewed by IVL as risk substances (see IVL’s report, appendix 2) as well as more general databases.

Based on the results of the literature study and screening analysis, IVL produced a list of substances recommended for further quantitative analyses. The substances were selected based on a number of criteria, such as having been detected in previous analyses presented in the literature study or in the screening analysis, and having a harmonised classification as allergenic, carcinogenic, mutagenic or the potential to harm human reproductive capacity or children’s development (see IVL’s report, appendix 2). Another ground for selection was that the substances occurred in the Nordic Council’s environmental labelling Nordic Swan Ecolabel’s criteria document for sanitary products.

IVL also evaluated data from the screening analysis of sanitary towels in collaboration with the Swedish Chemicals Agency. This added more substances to the list for further quantitative analyses.

2.5 Quantitative analyses of substances based on IVL’s investigation

Based on IVL’s recommendations regarding chemical substances for further analysis, as well as the additional substances sifted out from the evaluation of data from the screening analysis of sanitary towels, we made the assessment that 62 chemical substances were of interest for further quantitative analysis. The substances were considered relevant for further analysis because either the literature study revealed that they were present in previous investigations or they were detected in the screening analysis or mentioned in Nordic Swan Ecolabel’s criteria document for feminine hygiene products. These can for example be residues of pesticides from cotton and raw materials from forestry or residues of chemicals used in production.

The Swedish Chemicals Agency had the 62 chemical substances analysed in the 35 products in order to find out whether the substances were present in these products and, if so, in what concentrations. The analyses were performed by accredited laboratories at the request of Eurofins Environment Testing Sweden AB.

14 Liquid chromatography and mass spectrometry are two techniques for analysing chemical substances in articles and products. Liquid chromatography is a technique used to separate and analyse molecules or ions where the mobile phase is a liquid. Mass spectrometry, which is often used in combination with chromatography, is an analytical method for determining the mass of individual positive or negative ions.

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2.6 Health risk assessment of substances found in quantitative analyses

For the chemical substances found in feminine hygiene products, we performed health risk assessments in accordance with a worst-case scenario. This means that we assess the risk of negative health effects at the highest imaginable exposure that a consumer can be subjected to by using the product. In other words, we are exaggerating the exposure level in the calculations in order to be on the safe side. Should the risk of negative health effects in a worst-case scenario prove to be low, we can assume that the risk is also controlled at lower and more realistic exposure levels.

Figure 2. Schematic description of risk

The risk of a substance causing negative health effects depends on the substance’s inherent properties (i.e. how hazardous the substance is) and the exposure (how much of the substance a person is subjected to). By removing or decreasing exposure to a hazardous substance, the risk can be reduced. In order to assess the risk of negative health effects as a result of exposure to a hazardous substance, we also require information about the exposure level where, based on studies carried out, the substance is not expected to give rise to negative health effects (referred to as reference value). We also need to know how much of the substance is found in the product that users come into contact with.

First we made calculations of the exposure, i.e. how much of the chemical substance a consumer can be exposed to in a worst-case scenario when using the product.

The exposure calculations were based on how much of the chemical substance that can be extracted from the feminine hygiene product (concentration), the body weight of the youngest consumers and overestimated assumptions concerning the use of the product, and the proportion of the substance absorbed by the body:

· Highest measured concentration of each substance in the respective product type. · Estimated maximum weight and estimated minimum surface for each product type. · Average body weight of girls in year 5.15 · 100% migration of the substance from the feminine hygiene product during use. · 100% absorption of the substance via the skin. · 100% absorption of the substance via mucous membranes. · Daily use of the product.

o 5 new sanitary towels/panty liners/tampons per day. o 1 new menstrual cup per year.

We used the following equation to calculate the exposure level (Exp) for the chemical substances which may cause skin allergy:

15 Contact with the Swedish National Food Agency concerning their investigation Riksmaten ungdom 2016–17. A low body weight was used to ensure that the youngest group of users was also included.

Risk The likelihood that a substance will

cause negative health effects. In order to assess the risk, we require

information on both hazard and exposure.

Exposure How much of a

substance a person is subjected to over time

Hazard Inherent property of a substance which can entail negative health

effects

21

𝐸𝐸𝑥𝑥𝑥𝑥 𝑚𝑚𝑚𝑚/𝑐𝑐𝑚𝑚2 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 𝑎𝑎𝑎𝑎𝑎𝑎𝑎𝑎 = (𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 ∙ 𝑤𝑤/𝑆𝑆 ∙ 𝑀𝑀𝑀𝑀𝑀𝑀 ∙ 𝐴𝐴𝐴𝐴𝐴𝐴)

where Conc is the highest concentration of the chemical substance in the feminine hygiene product (mg/kg), w is the weight of the feminine hygiene product (kg), Mig is the proportion of the substance which migrates from the feminine hygiene product (we assumed that everything migrates: 100% = 1), Abs is the proportion of the substance absorbed by the body (we assumed that everything is absorbed: 100% = 1) and S is the surface of the sanitary towel or panty liner.

We used the following equation to calculate the exposure level for the chemical substances which have negative health effects other than skin allergy:

𝐸𝐸𝑥𝑥𝑥𝑥 𝑚𝑚𝑚𝑚𝑠𝑠𝑚𝑚 𝑠𝑠𝑏𝑏𝑏𝑏𝑏𝑏𝑏𝑏𝑎𝑎𝑠𝑠𝑚𝑚ℎ𝑠𝑠 /𝑏𝑏𝑎𝑎𝑏𝑏 = (𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 ∙ 𝑤𝑤 ∙ 𝑀𝑀𝑀𝑀𝑀𝑀 ∙ 𝐴𝐴𝐴𝐴𝐴𝐴 ∙ 𝑁𝑁)/𝐴𝐴𝑤𝑤

where N is the number of feminine hygiene products used each day and bw is the average weight of girls in year 5.

In order to assess the risk of a chemical substance having negative effects on people’s health, we compared the calculated exposure with a health-based reference value. A health-based reference value is a concentration of a substance that should not be exceeded, in order to avoid the risk of negative health effects. By dividing the exposure by the reference value, we obtain a risk characterisation ratio (RCR). If the RCR value is below 1 (i.e. the exposure is lower than the reference value), the risk can be considered sufficiently controlled. If the RCR value is above 1, it may indicate a risk which should be further addressed.

𝑅𝑅𝐶𝐶𝑅𝑅 = 𝐸𝐸𝑥𝑥𝑥𝑥𝐶𝐶𝐴𝐴𝐸𝐸𝐸𝐸𝐸𝐸

𝑅𝑅𝐸𝐸𝑅𝑅𝐸𝐸𝐸𝐸𝐸𝐸𝐶𝐶𝐶𝐶𝐸𝐸 𝑣𝑣𝑣𝑣𝑣𝑣𝐸𝐸𝐸𝐸

We obtained information on reference values for the various chemical substances from health risk assessments made by the European Chemicals Agency (ECHA)16, the World Health Organization (WHO)17, the European Food Safety Authority (EFSA)18 and from the REACH registrations made by the companies that manufacture or import the substances to Europe. In some cases, the Swedish Chemicals Agency derived its own reference values based on the registered information or based on published scientific studies, by following ECHA’s guidance. The choice of reference value can affect the results of the health risk assessment.

3 Results of our analysis Of the total 62 quantitatively analysed chemical substances, we found 21 substances over the reporting limit in samples of sanitary towels, panty liners, tampons or menstrual cups.

All analysis results (concentration in mg/kg) are provided in the tables in appendix 2. In the tables, the samples are referred to as Sanitary Towels 1–7, Panty Liners 1–10, Tampons 1–10 and Menstrual Cups 1–8. For more details on the samples, such as brand, see tables 1–4 above. The sample responses are given in relation to a reporting limit, which means the lowest concentration of a substance that can be measured with reasonable statistical certainty 16 ECHA: https://www.echa.europa.eu/information-on-chemicals/registered-substances (04/05/2018) and https://www.echa.europa.eu/documents/10162/77cf7d29-ba63-4901-aded-59cf75536e06 (04/05/2018). 17 WHO: http://www.who.int/water_sanitation_health/dwq/chemicals/formaldehyde.pdf (04/05/2018). 18 EFSA: https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2017.5013 (04/05/2018).

https://www.echa.europa.eu/information-on-chemicals/registered-substances

https://www.echa.europa.eu/documents/10162/77cf7d29-ba63-4901-aded-59cf75536e06

http://www.who.int/water_sanitation_health/dwq/chemicals/formaldehyde.pdf

https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2017.5013

22

in the chemical analysis in question. For examples of common areas of use for the 21 chemical substances, see table 5.

Sanitary towels The results show that of the 48 chemical substances which we analysed quantitatively in sanitary towels, we found 10 substances at low concentrations19 (read more about the health risk assessment in chapter 4). Formaldehyde was the only substance found in all sanitary towels.

Panty liners The results show that of the 47 chemical substances which we analysed quantitatively in panty liners, we found 13 substances at low concentrations. Formaldehyde and abietic acid were the only substances found in all panty liners.

Tampons The results show that of the 52 chemical substances which we analysed quantitatively in tampons, we found five substances at low concentrations. Formaldehyde was the only substance found in all tampons.

Menstrual cups The results show that of the eight chemical substances which we analysed quantitatively in menstrual cups, we found seven substances at concentrations above the reporting limit. The majority of substances were found in most of the products. In the menstrual cups manufactured by TPE (sample numbers 3 and 4), we found no hazardous chemical substances in either the screening or the quantitative analysis. The concentrations are generally low20. Compared with the other menstrual cups, menstrual cup numbers 7 and 8 contain higher concentrations of one or more analysed chemical substances.

3.1 Common areas of application for substances we found in feminine hygiene products

We have surveyed common areas of application primarily using information from the Swedish Chemicals Agency’s product register for the 21 chemical substances found in the feminine hygiene products; see table 5 below.

Table 5. Examples of common areas of application for the 21 chemical substances found in the feminine hygiene products.

Chemical substance EC no. CAS no. Examples of common areas of application

1,4-bis(2,3-epoxypropoxy)butane 219-371-7 2425-79-8 Hardener in paint, plastic, glue

1,4-bis[(vinyloxy)methyl]cyclohexane 413-370-7 17351-75-6 Binding agent in printing ink

19 By low concentrations in this report, we mean concentrations of less than 0.1 per cent weight by weight. 20 One of the substances, D6, was found at a concentration of 0.2 per cent weight by weight in menstrual cup number 7.

23


1-ethylpyrrolidin-2-on 220-250-6 2687-91-4 Solvent (e.g. in cosmetics); Plastic raw material

2-ethylhexyl acrylate 203-080-7 103-11-7 Raw material used in plastics manufacturing; Binding agent in paint, glue

Abietic acid (rosin) 208-178-3 514-10-3 Binding agent in glue

Adipic acid 204-673-3 124-04-9 Raw material for manufacturing paint, glue, paper, cosmetics

Benzophenone 204-337-6 119-61-9 Printing ink component; Hardener in paint; Rinsing agent for textiles; Raw material for cosmetics/hygiene industry (hand/body creams)

Citronellyl butyrate 205-463-4 141-16-2 Perfume (e.g. in cosmetics)

Decamethylcyclopentasiloxane (D5) 208-764-9 541-02-6 Raw material for cosmetics and hygiene products (e.g. as a humectant in skin care products); Raw material for rubber manufacturing

Decamethylcyclononasiloxane (D9) - 556-71-8 Contaminant in silicon material

Diantimony trioxide 215-175-0 1309-64-4 Catalyst in plastics manufacturing

Dibutyl phthalate 201-557-4 84-74-2 Softener in plastic, rubber, glue and paint; Solvent in printing ink

Dodecamethylcyclohexasiloxane (D6) 208-762-8 540-97-6 Raw material for cosmetics and hygiene products (e.g. as a humectant in skin care products)

Formaldehyde 200-001-8 50-00-0 Raw material for binding agent manufacturing (e.g. glue, paint); Disinfectant

Hexadecamethylcyclooctasiloxane (D8)

209-137-2 556-68-3 Contaminant in silicon material

Sodium dodecylbenzenesulfonate 246-680-4 25155-30-0 Detergent; Auxiliary (emulsifier) for manufacturing paper and plastic; components in odour masking agents

24


Neodecanoic acid 248-093-9 26896-20-8 Component in paint and lubricants; The salt form (with e.g. cobalt, copper or zinc) is used as a catalyst in paint and plastic

Octamethylcyclotetrasiloxane (D4) 209-136-7 556-67-2 Component in paint, glue, binding agent; Process-regulated agents in the chemical industry; Solvent; Raw material for cosmetics and hygiene products (e.g. as a humectant in skin care products)

Tetradecamethylcycloheptasiloxane (D7)

203-496-9 107-50-6 Contaminant in silicon material

Tributyl O-acetylcitrate 201-067-0 77-90-7 Softener in plastic, printing ink, paint for use in consumer products

ε-Caprolactam 203-313-2 105-60-2 Raw material for manufacturing paint, printing ink, glue, plastic

4 Health risk assessment of chemical substances in feminine hygiene products

We conducted health risk assessments for 18 of the 21 chemical substances found in the feminine hygiene products in order to investigate whether or not there may be a risk of negative health effects from use. We were unable to assess the risk of negative health effects from exposure to three substances found in menstrual cups, as we had insufficient data to perform calculations (see section 4.4).

4.1 In order to assess the health risk, we require information regarding the chemical substance’s hazardous properties

One means of gaining information about a chemical substance’s hazardous properties is to find out whether the substance has a harmonised classification. The harmonised classification describes the hazardous properties of the substance as jointly determined within the EU. For 10 of the 21 chemical substances, there is a harmonised classification related to a health hazard. Four substances found in the feminine hygiene products have a harmonised classification indicating that they may cause allergic skin reactions (see table 6). Three of the substances have a harmonised classification which means that they may, or are suspected to, damage fertility or harm the unborn child. Dibutyl phthalate, found in one sanitary towel and one panty liner, is included in the EU Candidate List of Substances of Very High Concern. It is important to note that the harmonised classification is only based on the substance’s inherent properties and not on the risk of negative health effects, as the risk also depends on how much of the hazardous substance the user of the product is exposed to over time (see

25

figure 2, chapter 2.6). A chemical substance may however have hazardous properties without having a harmonised classification. Other ways of gaining knowledge of the hazardous properties of a substance is through information from toxicological studies which can be found on ECHA’s website, if the substance is registered within the REACH regulation, or from the scientific literature.

4.2 In order to assess the health risk, we need to calculate the exposure to the chemical substance

In order to make an exposure assessment, information is required on how much of the chemical substance is present in the product that the user comes into contact with. We based our calculations on the highest measured concentration of the chemical substance in the various product types. The exposure is then calculated using various formulas, based on assumptions with regard to use of the feminine hygiene products and absorption of the chemical substance by the body. These formulas and assumptions are described in detail in chapter 2.6. Table 7 below presents the calculated exposure for each chemical substance from the feminine hygiene products that they were found in.

4.3 The risk characterisation ratio (RCR) indicates whether or not the risk of negative health effects is controlled

The risk of a chemical substance causing negative health effects depends on the substance’s inherent properties (i.e. how hazardous the substance is) and the exposure (how much of the substance a person is subjected to over time). In order to assess the risk of negative health effects from a hazardous substance, we also require information on the exposure where the substance does not give rise to negative health effects. Such information normally comes from experimental animal studies. A reference value is derived by dividing the exposure in the study by a number of assessment factors which, among other things, compensate for differences between animals and humans.

By dividing the calculated exposure by the reference value, we obtain a risk characterisation ratio (RCR). If the RCR is below 1, the risk can be considered sufficiently controlled, whilst a value above 1 may indicate a risk which should be further addressed.

The method we used for the health risk assessment of the chemical substances is described in detail in chapter 2.6.

We derived RCRs for systemic health effects which arise in parts of the body other than at the site of exposure and for skin allergy that arise at the site of exposure. We derived RCRs for skin allergy in cases where the chemical substance is known to cause skin allergy and where reference values or other toxicological information on skin allergy is available. The reference values and the calculated RCRs are presented in table 7 below.

The RCRs for the chemical substances found in the feminine hygiene products, and for which we were able to perform health risk assessments, were below 1. This means that the calculated exposure is lower than the exposure level considered to be safe, and that the risk of negative health effects when using these products is thereby controlled and very low. In cases where the chemical substances were found in several different types of feminine hygiene products, we also assessed the risk of negative health effects during combined use (e.g. using a tampon and a panty liner or a tampon and a sanitary towel at the same time). The RCR values were below 1 for these usage scenarios as well.

26

4.3.1 How to interpret risk characterisation ratios In our calculations, all RCR values are below 1. This means that the risk of negative health effects from exposure to hazardous chemical substances when using the feminine hygiene products investigated in this report is controlled and very low. The actual RCR values shown in table 7 should be interpreted with caution. It is not appropriate, for example, to compare the RCRs of different substances, as these are based on different types of experimental studies in which various types of health effects have been investigated. In deriving the reference values included in our calculations, assessment factors of different magnitudes have also been used, which in turn affects the reference value and the RCR.

The exposure calculations are also based on several assumptions in order to handle uncertainties. We have for example assumed that the substance is absorbed 100 per cent by the body via mucous membranes and skin, as there is no exact information in this regard at present. It is likely that the actual absorption and thereby the exposure to chemical substances from feminine hygiene products is lower, which would thus entail even lower RCR values.

4.3.2 Calculations of the health risk based on modified reference values The majority of reference values that we have used in the health risk assessment come from companies’ registrations of chemical substances published on ECHA’s website. In several cases, companies have used lower assessment factors than recommended in ECHA’s guidance to derive the reference value. In these cases, the Swedish Chemicals Agency performed additional calculations of the health risk by adding extra assessment factors. The calculations reveal that even with lower reference values, the RCRs are below 1.

Table 6. 21 chemical substances were found in feminine hygiene products. The table shows the substances harmonised classification, the reference values used in the calculations and the negative health effect that the reference value is based on.

Chemical substance

EC no. / CAS no.

Harmonised classification for health and hazard statement

Reference value used in the calculation (mg/kg body weight/day or mg/cm2)

Negative health effect (which the reference value is based on and which is based on experimental studies)

Reference Registered in accordance with REACH

1,4-bis(2,3-

epoxypropoxy)butane

219-371-7

/2425-79-8

Acute Tox. 4. Harmful if inhaled and in contact with skin. Eye Irrit. 2. Causes serious eye irritation. Skin Sens. 1. May cause an allergic skin reaction. Skin Irrit. 2. Causes skin irritation.

0.33 mg/kg bw/day There is no reference value for skin allergy.

Effects on weight. Effects on liver.

Substance’s registration dossier on ECHA’s website.21

Yes

21 ECHA: https://www.echa.europa.eu/information-on-chemicals/registered-substances (04/05/2018).

https://www.echa.europa.eu/information-on-chemicals/registered-substances

27

Chemical substance

EC no. / CAS no.





1,4-

bis[(vinyloxy)methyl]cyclohexane

413-370-7

/ 17351-

75-6

Skin Sens. 1. May cause an allergic skin reaction.

No reference values are available the registration dossier for the general population. 2.8 mg/kg bw/day for workers via skin exposure.

Effects on weight. Effects on the liver and kidneys.

Substance’s registration dossier on ECHA’s website.

Yes

1-ethylpyrrolidin

-2-one

220-250-6 / 2687-91-

4

Repr. 1B. May damage the unborn child.

0.5 mg/kg bw/day

Effects on weight. Effects on liver.


Yes

2-Ethylhexyl acrylate

203-080-7

/ 103-11-7

Skin Irrit. 2. Causes skin irritation. Skin Sens. 1. May cause an allergic skin reaction. STOT SE 3. May cause respiratory irritation.

0.242 mg/cm2 There are no reference values for effects other than skin allergy.

Skin allergy. Substance’s registration dossier on ECHA’s website.

Yes

Abietic acid

208-178-3

/ 514-10-3

None No reference values are available, but scientific studies exist. 0.021 mg/cm222

Skin allergy. Basketter et al.

200723

No

Adipic acid

204-673-3

/ 124-04-9

Eye Irrit. 2. Causes serious eye irritation.

19 mg/kg bw/day

Effects on weight.


Yes

Benzophenone

204-337-6

/ 119-61-9

None 0.03 mg/kg

bw/day

Effects on kidneys.

EFSA24 Yes

22 The reference value is derived by the Swedish Chemicals Agency by following ECHA’s guidance. 23 Basketter DA, Gerberick F, Kimber I. 2007. The local lymph node assay and the assessment of relative potency: status of validation. Contact Dermatitis 57(2): 70–75. 24 EFSA: https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2017.5013 (04/05/2018).

https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2017.5013

28

Chemical substance

EC no. / CAS no.





Citronellyl

butyrate

205-463-4

/ 141-16-2

None No reference values are available but scientific studies exists.

0.066 mg/cm225

Skin allergy. Substance’s registration

dossier on ECHA’s

website.

Yes

Decamethylcy

clopentasiloxane,

D5

208-764-9

/ 541-02-6

None 5 mg/kg bw/day No effects at the highest dose tested.

Substance’s

registration

dossier on ECHA’s

website.

Yes

Decamethylcy clononasiloxane,

D9

- / 556-71-8

None No reference values are available

No

Diantimonytrioxide

215-175-0

/ 1309-64-

4

Carc. 2.

Suspected of causing cancer.

33.5 mg/kg

bw/day

Effects on body weight. Effects on the liver.


Yes

Dibutyl phthalate

201-557-4

/ 84-74-2

Repr. 1B. May damage the unborn child. Suspected of damaging fertility.

0.007 mg/kg

bw/day

Reproductive toxicity.

Substance’s registration dossier on ECHA’s website

Yes

Dodecamethylcyclohexasiloxane, D6

208-762-8 / 540-97-6

None 1.7 mg/kg bw/day

No effects at the highest dose tested.


Yes

25 Basketter DA, Gerberick F, Kimber I. 2007. The local lymph node assay and the assessment of relative potency: status of validation. Contact Dermatitis 57(2): 70–75.

29

Chemical substance

EC no. / CAS no.





Formaldehyde

200-001-8 / 50-00-0

Acute Tox. 3. Toxic if swallowed, in contact with the skin and if inhaled. Carc. 1B. May cause cancer.

Muta. 2. Suspected of causing genetic defects. Skin Corr. 1B. Causes severe skin burns and eye damage. Skin Sens. 1. May cause an allergic skin reaction.

0.15 mg/kg bw/day 0.012 mg/cm2 (skin allergy)

Skin allergy and effects on kidneys.

Substance’s registration dossier on ECHA’s website and WHO26

Yes

Hexadecamethylcyclooctasiloxane, D8

209-137-2

/ 556-68-3

None No reference values are available.

No

Sodium dodecylbenzenesulfonate

246-680-4/

25155-30-

0

None 13 mg/kg bw/day

Acute toxicity. Substance’s registration dossier on ECHA’s website.

Yes

Neodecanoic acid

248-093-9

/ 26896- 20-8

None 1.06 mg/kg bw/day

Reproductive toxicity


Yes

Octamethylcyclotetrasiloxane, D4

209-136-7 / 556-67-2

Repr. 2. Suspected of damaging fertility.

3.7 mg/kg bw/day

Effect on kidneys. Tumours.


Yes

Tetradecamethylcycloheptasiloxane, D7

203-496-9

/ 107-50-6

None No reference values are available.

No

26 WHO: http://www.who.int/water_sanitation_health/dwq/chemicals/formaldehyde.pdf (04/05/2018).

http://www.who.int/water_sanitation_health/dwq/chemicals/formaldehyde.pdf

30

Chemical substance

EC no. / CAS no.





Tributyl O-acetylcitrate

201-067-0

/ 77-90-7

None 1 mg/kg bw/day Effects on liver. Substance’s registration dossier on ECHA’s website.

Yes

ε-caprolactam

203-313-2

/ 105-60-2

Acute Tox. 4. Toxic if swallowed or inhaled. Eye Irrit. 2. Causes serious eye irritation. Skin Irrit. 2. Causes skin irritation. STOT SE 3. May cause respiratory irritation.

8.55 mg/kg bw/day There is no reference value for skin allergy.

Effects on liver. Substance’s registration dossier on ECHA’s website.

Yes

Table 7. Health risk assessments were performed for 18 chemical substances found in the feminine hygiene products. The table presents the calculated exposure, the reference value used in the health risk assessment and the risk characterisation ratio (RCR) for each chemical substance for the product types in which the substances were found.

Chemical substance

EC no. / CAS no.

Exposure (mg/kg body weight/day) or concentration in the product mg/cm2 (for skin allergens)

Reference value used in the calculations (mg/kg body weight/day or mg/cm2 for skin allergens)

Risk characterisation ratio (exposure/reference value) RCR

1,4-bis(2,3- epoxipropoxy)butane

219-371-7 /

2425-79-8

Sanitary towel: 0.002 Panty liner: 0.00007 Tampon: 0.0003

0.33 mg/kg bw/day Sanitary towel: 0.006 Panty liner: 0.0002 Tampon: 0.0009

1,4-

bis[(vinyloxy)methyl]cyclohexane

413-370-7

/ 17351- 75-6

Tampon: 0.002 2.8 mg/kg bw/day Tampon: 0.0007

1-Ethyl-2-pyrrolidone

220-250-6

/ 2687-91- 4

Panty liner: 0.0002

0.5 mg/kg bw/day Panty liner: 0.0004


203-080-7

/ 103-11-7

Sanitary towel: 0.00006 Panty liner: 0.0003

0.242 mg/cm2 Sanitary towel: 0.0002 Panty liner: 0.001

31

Chemical substance

EC no. / CAS no.




Abietic acid 208-178-3

/ 514-10-3


0.021 mg/cm2 Sanitary towel: 0.5 Panty liner: 0.04

Adipic acid 204-673-3 / 124-04-9

Panty liner: 0.0001

19 mg/kg bw/day Panty liner: 0.000005

Benzophenone

204-337-6

/ 119-61-9

Menstrual cup: 0.0008

0.03 mg/kg bw/day Menstrual cup: 0.03

Citronellyl butyrate

205-463-4

/ 141-16-2


0.066 mg/cm2* Sanitary towel: 0.02 Panty liner: 0.1

Decamethylcyclopentasiloxane, D5

208-764-9

/ 541-02-6


5 mg/kg bw/day Menstrual cup: 0.0002

Diantimony trioxide

215-175-0

/ 1309-64-

4


33.5 mg/kg bw/day Sanitary towel: 0.0009 Panty liner: 0.0006 Tampon: 0.001

Dibutyl phthalate

201-557-4

/ 84-74-2


0.007 mg/kg bw/day Sanitary towel: 0.1 Panty liner: 0.03


208-762-8 / 540-97-6



Formaldehyde 200-001-8

/ 50-00-0


0.15 mg/kg bw/day



/

50-00-0


0.012 mg/cm2 (skin allergy)



246-680-

4/ 25155-

30-0


13 mg/kg bw/day Sanitary towel: 0.02 Panty liner: 0.004

Neo-decanoic acid

248-093-9

/ 26896-

20-8

Panty liner: 0.0002

1.06 mg/kg bw/day Panty liner: 0.0002


209-136-7

/ 556-67-2



32

Chemical substance

EC no. / CAS no.





201-067-0

/ 77-90-7


1 mg/kg bw/day Sanitary towel: 0.03 Panty liner: 0.003 Tampon: 0.002

ε-caprolactam 203-313-2

/105-60-2


8.55 mg/kg bw/day Sanitary towel: 0.0008 Panty liner: 0.0001

Formaldehyde was found in all sanitary towels, panty liners and tampons. Studies have shown that formaldehyde can be carcinogenic27 28. In the EU, formaldehyde has a harmonised classification as carcinogenic, mutagenic and allergenic to the skin. However, an evaluation carried out by SCOEL29 , among others, emphasises that the mutagenic and carcinogenic effects of formaldehyde are very low at a low level of exposure. The feminine hygiene products analysed in this report revealed low formaldehyde content, and we therefore make the assessment that the risk of such negative health effects is low.

Abietic acid was found in sanitary towels and panty liners and may, according to the Swedish Chemicals Agency’s product register, be present as a binding agent in glue. Abietic acid is not registered within REACH as an individual substance and there is consequently no information available on ECHA’s website on the substance’s hazardous properties. We did, however, find studies in the scientific literature which could be used as a basis for an assessment of the risk of developing skin allergy. The calculated RCRs are presented in table 7 above. We found no information in the literature regarding any other health effects resulting from exposure to abietic acid. According to several information sources, abietic acid is a component of rosin, also known as colophony or tall oil rosin. Rosin has a harmonised classification indicating that the substance may cause skin allergy.

4.4 No health risk assessment for three chemical substances There is a lack of information on health effects for three of the chemical substances (D7, D8 and D9; see full substance names in table 5) found in silicon menstrual cups. These substances are not registered within REACH, which means that there is no information on the substances on ECHA’s website. Nor did we find any information on hazardous properties in the scientific literature.

D7, D8 and D9, just as D4, D5 and D6 (see table 5), belong to the group of “siloxanes”. Siloxanes are primarily known for being hazardous to the environment. In June 2018, D4, D5 and D6, was therefore added to the Candidate List of Substances of Very High Concern in the EU. For the same reason, the use of D4 and D5 is limited in certain types of cosmetic products30. D7, D8 and D9 are larger molecules than D4, D5 and D6, but are probably very

27 IARC 2012: http://monographs.iarc.fr/ENG/Monographs/vol100F/mono100F-29.pdf (03/05/2018) 28 WHO 2002: http://www.who.int/ipcs/publications/cicad/en/cicad40.pdf (03/05/2018) 29 SCOEL: Scientific Committee on Occupational Exposure Limits: https://circabc.europa.eu/sd/a/2882e9bc-d52e-4944-ac08-974b43957ed2/REC-125%20Formaldehyde.pdf (03/05/2018) 30 EurLex: http://eur-lex.europa.eu/legal-content/SV/TXT/PDF/?uri=CELEX:32018R0035&from

http://monographs.iarc.fr/ENG/Monographs/vol100F/mono100F-29.pdf

http://www.who.int/ipcs/publications/cicad/en/cicad40.pdf

https://circabc.europa.eu/sd/a/2882e9bc-d52e-4944-ac08-974b43957ed2/REC-125%20Formaldehyde.pdf

https://circabc.europa.eu/sd/a/2882e9bc-d52e-4944-ac08-974b43957ed2/REC-125%20Formaldehyde.pdf

http://eur-lex.europa.eu/legal-content/SV/TXT/PDF/?uri=CELEX:32018R0035&from

33

similar to them in many other respects. We currently do not have sufficient information on D7, D8 and D9 to perform a health risk assessment. However, there is currently nothing to indicate that exposure to the substances would pose a health risk.

Based on the information on the manufacturing process for silicon, we can assume that D7, D8 and D9 are present as impurities in the material and that they are not intentionally added. The highest concentrations in the menstrual cups analysed were 0.002 (D7), 0.005 (D8) and 0.08 (D9) per cent weight by weight. The EU regulatory framework seldom takes such low concentrations into account. Companies are for example not obliged to provide information to users on substances of very high concern (SVHC) if they are present at concentrations below 0.1 per cent weight by weight in articles, or for example give warnings about substances with harmonised classifications such as carcinogenic or mutagenic, if their concentration in the product is below 0.1 per cent.

5 Discussion and conclusions Investigations of chemical substances in products are often limited to quantitative methods, where via analyses it is possible to gain concentrations of substances already identified through literature studies and experience. In this investigation, we went one step further and performed a screening analysis in which we first surveyed a large quantity of the chemical substances which can be found in a feminine hygiene product. The reason for this is that we wanted to include as many potentially hazardous chemicals as possible in products which are used in close proximity to the body and used regularly by a large proportion of the population for much of their life.

Commissioned by the Swedish Chemicals Agency, IVL Swedish Environmental Research Institute also conducted a literature study, with the conclusion that the information available today on chemical substances in feminine hygiene products is very limited. Nor have we been able to find any other studies in which the chemical content of feminine hygiene products has been subject to an unbiased investigation via screening analysis.

Through literature studies and screening analysis of 35 different feminine hygiene products purchased on the Swedish market, we were able to identify 62 hazardous chemical substances that were of relevance to proceed with in the quantitative analysis of the products (see IVL’s report, appendix 2 to this report). The quantitative analysis revealed that 21 of the 62 chemical substances were found above the reporting limit in some of the products. 41 of the chemical substances we analysed could not be found in concentrations above the reporting limit in any product. Risk assessments for negative health effects could be performed for 18 of the 21 substances we found, whilst there was insufficient information for three of the substances to perform calculations. One substance which has been particularly discussed in connection with feminine hygiene products is glyphosate. Previous analyses revealed very low concentrations of glyphosate, but we chose to analyse this substance in the products nonetheless. We found neither glyphosate nor its decomposition product AMPA in any of our analyses.

When it comes to the “dioxins” group of substances, IVL established following its literature study that the presence of dioxins in feminine hygiene products is already well researched. This substance group has proven to exist in feminine hygiene products on a par with the background level in the environment, and the exposure to dioxins from the use of tampons is negligible. Our assessment led to the same conclusion and we therefore chose not to include dioxins in our quantitative analyses.

34

The products marketed with statements regarding odour control or scenting have not in our analyses proven to contain more harmful substances than the other feminine hygiene products. There is however a possibility that with the choice of analysis method we have failed to detect the presence of more volatile substances31 which could be the cause of all of the symptoms experienced when using scented feminine hygiene products.

The Chemicals Agency’s assessment – low health risk The Chemicals Agency considers there to be a low risk of negative health effects arising from exposure to the chemical substances that we have found in the analysed feminine hygiene products and for which we have been able to carry out a health risk assessment. This means that we consider it safe to continue using these products without health concerns.

Moving on – alerting companies to problematic substances When analysing the occurrence of the 62 harmful chemical substances, we were unable to find 41 of them in any of the feminine hygiene products. The 21 substances that we detected mainly occurred in low concentrations32 and we consider the risk of negative health effects when using the products to be low. With this said, six of the substances33 found in the products are listed in the International Chemical Secretariat’s database34 and three of the substances are also included in ECHA’s evaluation list35. For three substances, D7, D8 and D9, there is not enough toxicological information for us to assess the risk of negative health effects. These three chemical substances are most likely impurities arising during the production of silicone materials. However, there is nothing to currently indicate that exposure to the substances would pose a health risk.

The Chemicals Agency is tasked with phasing out chemical substances with especially hazardous properties to our local environment. This is part of the overall work with the Government’s environmental quality objective of a Non-Toxic Environment and the Chemicals Agency’s assignment regarding an action plan for a non-toxic everyday environment. The Chemicals Agency will therefore maintain a dialogue with the manufacturers and importers to inform them of the analysis results of this report. We also add the substances to the Chemicals Agency’s general surveying efforts in order to determine if these are substances that we deem to be necessary to address in the future.

31 Volatile substances are substances which easily vaporise. 32 Of these 21 substances, 20 were under 0.1 per cent weight by weight, which is our limit for low content. One of the substances, D6, was detected at 0.2 per cent weight by weight. 33 The six substances found in the Evaluation list and/or ChemSec are 1-ethyl pyrrolidone-2-one, benzophenone, antimony trioxide, dibutyl phthalate, formaldehyde and octamethylcyclotetrasiloxane (D4). 34 ChemSec has a database of substances identified by the organisation as especially hazardous substances, based on criteria defined in REACH. The database is known as the SIN (Substitute It Now) list. 35 Substance evaluation, CoRAP (Community rolling action plan). A substance being on this list means that an EU member state has evaluated or will evaluate it within the next few years. The substances found on the Evaluation list are: benzophenone, antimony trioxide, and formaldehyde, and work is ongoing on all substances. The Chemicals Agency is actively working within the EU on evaluating various chemical substances through its own evaluations, and by commenting on the evaluations made by other countries.

35

Appendix 1. Method

Product samples – selection, purchase and transportation For our survey to cover as much as possible of the Swedish market, and to include more marginal products that may be used by limited segments of the population, we also looked up what products are available via online vendors. All leading brands, several products that claimed to have “odour control” and some ecolabelled products were selected. As many products seem to have similar designs and compositions, we selected a number of typical products. For the menstrual cups, we included most brands that are marketed in Sweden. A list of suitable products was drawn up and purchases were distributed among various stores, mainly grocery stores and pharmacies in the Stockholm area including Bålsta, Jakobsberg, Rinkeby, Sundbyberg and central Stockholm. We primarily bought the products in stores, but the menstrual cups were mainly bought online, as it seemed to be the easiest and most common way to buy them. All products were bought by the Chemicals Agency’s inspectors.

One unopened package of each panty liner, tampon and sanitary towel, and two unopened packages of each menstrual cup were delivered in person to IVL in Stockholm for an initial screening. All details regarding IVL’s handling of the samples can be found in Appendix 2.

The products that were later examined at Eurofins’s laboratories were sealed in unbroken packages in a larger cardboard box and sent by courier to Eurfins in Lidköping. After being notified by Eurofins that the material might not be sufficient to cover all analyses, we provided additionally purchased products which were submitted in the same way.

Eurofins divided the quantitative analyses between two laboratories, one in Germany and one in China, as neither laboratory had the expertise and equipment to handle all the analyses that we had requested.

The part of tampons, sanitary towels and panty liners that is used, i.e. excluding protective strips and packaging, was ground up and a suitable standard solution was added before mixing with relevant extraction solvents. The mixture was also processed, depending on the substance that the analysis concerned, in a microwave oven or ultrasonic bath. Analyses were then carried out according to the tables below. Sample preparation and analysis of the menstrual cups was done in the same way and excluding the packaging materials. The menstrual cups were not boiled before analysis, despite this being recommended before use by some manufacturers.

Table 8. Analysis method per analysed substance. Method description can be found in table 9.

Substance CAS number

Method number

Formaldehyde 50-00-0 1

Glutaraldehyde 111-30-8 1

Butyl methacrylate 97-88-1 2

Isopropyl alcohol 67-63-0 2

Vinyl acetate 108-05-4 2

Octamethylcyclotetrasiloxane, D4 556-67-2 2

36


Method number

Decamethylcyclopentasiloxane, D5 541-02-6 2

Styrene 100-42-5 2

1-Propene, 1,3-dichloro-, (1E)- 10061-02-6 2

1-Propene, 1,3-dichloro-, (Z)- 10061-01-5 2

1-Propene, 1,3-dichloro-, 542-75-6 2

1-Propene, 2,3-dichloro-, 78-88-6 2

Methylbenzene (toluene) 108-88-3 2

Caprolactam 105-60-2 3a

Oxirane, 2,2'-[1,4- butanediylbis(oxymethylene)]bis-

2425-79-8 3a

Cyclohexane, 1,4-bis[(ethenyloxy)methyl]- 17351-75-6 3a

Cyclohexene, 1-methyl-4-(1-methylethenyl)-, (4S)-

5989-54-8 3a

Cyclohexene, 1-methyl-4-(1-methylethenyl)-, (4R)-

5989-27-5 3a

2-Propenoic acid, 2-methyl-, (tetrahydro-2- furanyl)methyl ester

2455-24-5 3a

Butanoic acid, 3,7-dimethyl-6-octen-1-yl ester

141-16-2 3a

Cyclohexene, 1-methyl-4-(1-methylethenyl)-

138-86-3 3a

2-Propenoic acid, 2-ethylhexyl ester 103-11-7 3a

2-Pyrrolidinone, 1-ethyl- 2687-91-4 3a

D6 3a

D7

3a

D8

3a

D9

3a

Phenol, 2,4(or 2,5)-dimethyl- 71975-58-1 3b

Phenol, dimethyl- 1300-71-6 3b

Phenol, 2,6-dimethyl- 576-26-1 3b




37


Method number


Phenol, dodecyl-, branched 121158-58-5 3b

Benzophenone 119-61-9 3c

Diisobutyl phthalate 84-69-5 3c

1,2-Benzenedicarboxylic acid, 1,2-dibutyl ester

84-74-2 3c

1,2,3-Propanetricarboxylic acid, 2- (acetyloxy)-, 1,2,3-tributyl ester

77-90-7 3c

PAH, 16 substances 3d

Adipic acid 124-04-9 3e

Abietic acid 514-10-3 3e

Dimethylacetamide 127-19-5 3f

Dimethylformamide ..68-12-02 3f

Acrylamide ..79-06-01 3f

Neodecanoic acid, nickel(2+) salt 85508-44-7 3g

Nonylphenolethoxylates 127087-87-0 4a

Glyphosate 70393-85-0 6a

Aminomethylphosphonic acid (AMPA) 1066-51-9 6a

Malaoxon/Malathion 121-75-5 6b

Dichlofluanid 1085-98-9 6b

Procymidone 32809-16-8 6b

Methidathion 950-37-8 6b

Fensulfothion 115-90-2 6b

Piperonyl Butoxide 06/03/1951 6b

Cyclopropanecarboxylic acid, 2,2-dimethyl- 3-(2-methyl-1-propenyl)-, 2-methyl-4-oxo-3- (2-propynyl)-2-cyclopenten-1-yl ester

23031-36-9 6b

Cyclopropanecarboxylic acid, 2,2-dimethyl- 3-(2-methyl-1-propenyl)-, 2-methyl-4-oxo-3- (2,4-pentadienyl)-2-cyclopenten-1-yl ester, [1R-[1.alpha.[S*(Z)],3.beta.]]-

121-21-1 6b

Pentachloronitrobenzene 82-68-8 6b

Hexachlorobenzene 118-74-1 6b

38


Method number

Mecarbam 2595-54-2 7

Organotin compounds

9

2,2-dichloro-4,4-methylenedianilin 101-14-4 10a

Benzenesulfonic acid, dodecyl- 27176-87-0 10c

Benzenesulfonic acid, dodecyl-, sodium salt (1:1)

25155-30-0 10c

Benzenesulfonic acid, dodecyl-, potassium salt (1:1)

27177-77-1 10c

Benzenesulfonic acid, 4-dodecyl- 121-65-3 10c

Benzenesulfonic acid, dodecyl-, ammonium salt (1:1)

1331-61-9 10c

Arsenic and its compounds

EPA

Antimony trioxide 1309-64-4 EPA

Methylisothiazolinone 2682-20-4 10b

Methylchloroisothiazolinone 26172-55-4 10b

Table 9. Description of analysis methods for quantitative analyses of chemical substances in selected feminine hygiene products in the Swedish market. Processing of data from Eurofins Environmental Testing Sweden AB.

Method number

Description

1 GC/MS after water/THE extraction, Derivatisation with PFBHA and Hexane-extraction Formaldehyde alternatively : Formaldehyde (textile) DIN 14184 Method accredited

2 1-15_GC/MS, desorption with water (or DMA) Method accredited

3a GC MS 1 extraction with ethylacetate Method accredited for fragrances

3b

GC MS after extraction with ethylacetate and Silylation Method accredited for water

3c GC MS 2 after extraction with ethylacetate Method and parameter accredited

3d

According to German standard AfPS GS 2014:01. Accredited.

3e GC MS after extraction with ethylacetate Methylation we have a flexible accreditation for the determination of contaminants in material

39

Method number

Description

3f

GC MS CAM after extraction with ethylacetate we have a flexible accreditation for the determination of contaminants in material

3g GC MS FFAP after extraction with ethylacetate we have a flexible accreditation for the determination of contaminants in material

4 LC/MS/FDNot accredited

5 HR-GC-MS or GC-000 after extraction incl. ISTD addition and column clean up Accredited for all 17 dioxins/furans for products

6a

PSM 1C/MS/MS after extraction with ACN Method and parameter accredited

6b PSM LC/M5/M5 and GC/M5 after extraction with ACN Method and parameter accredited

7 Dithios HS-GC/MS after cleavage with tin Il chloride as C52 Method and parameter accredited

8 ICP/DAS or ICP/AES after acid digestion Method and parameter accredited

9 organotin GC/MS after extraction with ethanol and alkylation Method and parameter accredited

10a LC MS after extraction with CAN Method and parameter accredited for colours

10b

LC MS after extraction with CAN Method and parameter accredited for colours

10c LC-MS/MS after extraction Not accredited

40

Appendix 2. Results The four tables in appendix 2 contain all results of the quantitative chemical analyses of sanitary towels, panty liners, tampons and menstrual cups which we carried out in this study.

Sanitary towels The table below shows the results of the quantitative chemical analyses of sanitary towels. The selection of chemical substances is based on the previous screening analysis and literature study (see chapters 2.4 and 2.5).

Table 10. Concentrations of quantitatively analysed chemical substances in sanitary towels (mg/kg). RL denotes the reporting limit and is individually specified for each substance in mg/kg. UR means that the quantity is under the reporting limit. In cases where a substance has not been analysed in the sample (marked with ”-”), it has been assessed that the analysis is not relevant to the product, for example because the product does not contain materials where the substance in question is normally found or because our screening analysis has shown that the substance is not present in the product.

Chemical substance EC no. / CAS no.

1 2 3 4 5 6 7 RL

(Aminomethyl)phosphonic acid (AMPA)

623-325-5/ 1066-51-9 UR UR UR UR UR UR UR 0.05


219-371-7 / 2425-79-8

0,51- 0.94

UR UR UR 1,1- 1.5

UR -

0.77

UR 0.5

1,4-bis[(vinyloxy)methyl] Cyclohexane

413-370-7 / 17351-75-6 UR UR UR UR UR UR UR 2

1-Ethyl-2-pyrrolidone 220-250-6 / 2687-91-4 UR UR UR UR UR UR UR 0.5

2,2′-Dichloro-4,4′- methylenedianiline

202-918-9/ 101-14-4 UR UR UR UR UR UR UR 1

2,3-Dichloropropene 201-153-8/ 78- 88-6 UR UR UR UR UR UR UR 5

2,3-Xylenol 526-75-0 UR UR UR UR UR UR UR 0.05

2,4-Xylenol 203-321-6/ 105-67-9 UR UR UR UR UR UR UR 0.05

2,5-Xylenol 202-461-5/ 95- 87-4 UR UR UR UR UR UR UR 0.05

2,6-Xylenol 209-400-1/ 576-26-1 UR UR UR UR UR UR UR 0.05

2-Ethylhexyl acrylate 203-080-7 / 103-11-7

UR 1.1- 1.1

0,62- 0.65

UR UR UR UR 0.5

3,4-Xylenol 202-439-5/ 95- 65-8 UR UR UR UR UR UR UR 0.05

Abietic acid 208-178-3 / 514-10-3

0,87- 3.2

0,38- 0.53

1,5- 1.6

3,5- 4.1

1,1- 1.4

UR 200- 240 0.05

Adipic acid 204-673-3 / 124-04-9 UR UR UR UR UR UR UR 0.1

Acrylamide 201-173-7 /79- 06-1 UR UR UR UR UR UR UR 0.1

41


1 2 3 4 5 6 7 RL

Arsenic and its compounds - UR UR UR UR UR UR UR 8

Butyl methacrylate 202-615-1/ 97-88-1 UR UR UR UR UR UR UR 10

Cis-1,3-Dichloropropene

233-195-8/ 10061-01-5 UR UR UR UR UR UR UR 5

Citronellyl butyrate 205-463-4 / 141-16-2

12-19 15- 16

UR UR 5,4- 7.9

13- 14

6.4-6.6 5

Diantimony trioxide 215-175-0 / 1309-64-4

UR 24- 28

UR UR UR 20- 22

UR 10

Dibutyl phthalate 201-557-4 / 84-74-2

UR UR 0,53- 1.0

UR UR UR UR 0.5

Diisobutyl phthalate 201-553-2/ 84- 69-5 UR UR UR UR UR UR UR 1

Dimethylacetamide 204-826-4/ 127-19-5 UR UR UR UR UR UR UR 0.1

Dodecylphenol, various isomers (branched)

310-154-3/ 121158-58-5

UR

UR

UR

UR

UR

UR

UR

5

Formaldehyde 200-001-8 / 50-00-0

3.8-4.0 0,6- 1.0

1,1- 1.2

1,6- 1.7

1,8- 1.8

2,2- 3.2

0,52- 0.69 0.5

Glutaraldehyde 203-856-5/ 111-30-8 UR UR UR UR UR UR UR 0.2

Glyphosate 213-997-4/ 1071-83-6 UR UR UR UR UR UR UR 0.1

Hexafluorobenzene 204-273-9/ 118-74-1 UR UR UR UR UR UR UR 0.1

Isopropyl alcohol 200-661-7 / 67-63-0 UR UR UR UR UR UR UR 50

Methylchloroisothiazolinone

247-500-7/ 26172-55-4 UR UR UR UR UR UR UR 1

Quintozene (ISO) 201-435-0/ 82- 68-8 UR UR UR UR UR UR UR 0.1

Limonene 205-341-0/ 138-86-3 UR UR UR UR UR UR UR 0.5

Methylisothiazolinone 220-239-6/ 2682-20-4 UR UR UR UR UR UR UR 1

N,N-dimethylformamide

200-679-5/ 68- 12-2 UR UR UR UR UR UR UR 0.5


246-680-4/ 25155-30-0

UR UR UR UR 52-60 200- 230

UR 30

Neo-decanoic acid 248-093-9 / 26896-20-8 UR UR UR UR UR UR UR 0.1

Nonylphenolethoxylates

500-315-8/ 127087-87-0 - - - - - - UR 0.1

PAH 16 substances - UR UR UR UR UR UR UR 0.2

Prallethrin (ISO) 245-387-9/ 23031-36-9 UR UR UR UR UR UR UR 0.1

42


1 2 3 4 5 6 7 RL

Pyrethrin I 204-455-8/ 121-21-1 UR UR UR UR UR UR UR 0.1

Styrene 202-851-5/ 100-42-5 UR UR UR UR UR UR UR 5

Organotin compounds - UR UR UR UR UR UR UR 0.005

Tetrahydrofurfuryl Methacrylate

219-529-5/ 2455-24-5 UR UR UR UR UR UR UR 0.5

Toluene 203-625-9/ 108-88-3 UR UR UR UR UR UR UR 5

Trans-1,3-Dichloropropene

626-466-0/ 10061-02-6 UR UR UR UR UR UR UR 5

Tributyl O-acetylcitrate 201-067-0 / 77-90-7

19-29 0,99- 2.3

2,5- 5.4

3,6- 4.6

UR 9,3- 15

UR 0.5

Vinyl acetate 203-545-4 / 108-05-4 UR UR UR UR UR UR UR 10

ε-Caprolactam 203-313-2 / 105-60-2 UR UR UR UR UR 5,5-

5.9 UR 0.5

The results show that of the 48 chemical substances quantitatively analysed in sanitary towels, 10 substances were found in low concentrations36 (see more about the health risk assessment in chapter 4). Only formaldehyde was found in all sanitary towels.

Panty liners The table below shows the results of the quantitative chemical analyses of panty liners. The selection of substances is based on the previous screening analysis and literature study (see chapters 2.4 and 2.5).

Table 11. Concentrations of quantitatively analysed chemical substances in panty liners (mg/kg). RL denotes the reporting limit and is individually specified for each substance in mg/kg. UR means that the quantity is under the reporting limit.

Chemical substance

EC no. / CAS no.

1 2 3 4 5 6 7 8 9 10 RL


623-325-5/ 1066-51-9 UR UR UR UR UR UR UR UR UR UR 0.05


219-371-7

/ 2425-79-8

0,8- 1.0

0.9 8- 1.7

0.89 -1.1

UR

UR- 0.5 7

UR

UR

0.55

-1.4

UR

UR -

0.5 2

0.5

1,4- bis[(vinyloxy)methyl] Cyclohexane

413-370-7

/ 17351-75-

6

UR

UR

UR

UR

UR

UR

UR

UR

UR

UR

2

1-Ethyl2-pyrrolidone

220-250-6 /

2687-91-4

UR UR UR- 0.56

UR- 0.55

UR UR UR UR UR UR 0.5

36 Low concentrations are defined in this report as below 0.1 per cent weight by weight.

43

Chemical substance

EC no. / CAS no.

1 2 3 4 5 6 7 8 9 10 RL


202-918-9/ 101-14-4 UR UR UR UR UR UR UR UR UR UR 1

2,3-Dichloropropene


2,3-Xylenol 526-75-0 UR UR UR UR UR UR UR UR UR UR 0.05

2,4-Xylenol 203-321-6/ 105-67-9 UR UR UR UR UR UR UR UR UR UR 0.05



2- Ethylhexyl acrylate

203-080-7

/ 103-11-7

0.92

-1.1

0.5 4- 0.5 7

3,5- 6.3

4,0- 7.7

UR

UR

UR

UR

0.92 –

1.2

UR

0.5


Abietic acid

208-178-3

/ 514-10-3

7,3- 7.9

1,5- 1.8

3,6- 3.9

3,6- 3.8

2,3- 2.6

16- 21

0.5 2- 0.6 6

4,6- 4.7

2,4- 5.2

0.2 3- 0.2 7

0.05

Adipic acid 204-673-3

/ 124-04-9

UR

UR

UR

UR

UR

UR

UR

UR

0.29 -

0.33

UR

0.1

Acrylamide 201-173-7 /79-06-1 UR UR UR UR UR UR UR UR UR UR 0.1

Arsenic and its compounds - UR UR UR UR UR UR UR UR UR UR 8

Butyl methacrylate


Cis-1,3- Dichloropropene

233-195-8/ 10061-01-

5

UR UR UR UR UR UR UR UR UR UR 5


205-463-4 /

141-16-2

34- 34

6,6- 7.4

100 -

210

76- 85

22- 25

21- 27

5,6- 8

UR 15-

18 26- 30

5

Diantimony trioxide

215-175-0 /

1309-64-4

67- 68 UR UR UR 32-

35 UR UR UR UR UR 10

Dibutyl phthalate

201-557-4

/ 84-74-2,

93952-11-5

UR

0.5 1- 0.5 9

UR

UR

UR

UR

UR

UR

UR

UR

0.5

Diisobutyl phthalate


Dimethylacetamide



310-154-3/

121158-58-5

UR

UR

UR

UR

UR

UR

UR

UR

UR

UR

5

44

Chemical substance

EC no. / CAS no.

1 2 3 4 5 6 7 8 9 10 RL


/ 50-00-0

0,9- 1.9

6,1- 6.9

0.25 -

0.25

3,0- 3.4

3,3- 4.2

1,0- 1.5

1,1- 1.6

1,2- 1.4

6,8- 8.9

4.5 -

4.7

0.5

Glutaraldehyde 203-856-5 / 111-30-8 UR UR UR UR UR UR UR UR UR UR 0.2

Glyphosate 213-997-4/ 1071-83-6 UR UR UR UR UR UR UR UR UR UR 0.1

Hexafluorobenzene


Isopropyl alcohol 200-661-7 /

67-63-0



247-500-7/ 26172-55-

4


Quintozene (ISO)


Limonene 205-341-0/ 138-86-3 UR UR UR UR UR UR UR UR UR UR 0.5

Methylisothiazolinone


N,N- dimethylformamide

200-679-5/ 02/12/1968 UR UR UR UR UR UR UR UR UR UR 0.5


246-680-4/ 25155-30-

0

UR

UR 23 -

28

110 -

140

UR

UR

UR

UR

UR

UR

30

Neo-decanoic acid

248-093-9 /

26896-20-8

0.71 -

0.72

UR

UR

UR

UR

UR

UR

UR

UR

UR

0.1

PAH 16 substances

- UR UR UR UR UR UR UR UR UR UR 0.2

Prallethrin (ISO) 245-387-9/ 23031-36-

9

UR UR UR UR UR UR UR UR UR UR 0.1

Pyrethrin I 204-455-8/ 121-21-1 UR UR UR UR UR UR UR UR UR UR 0.1

Styrene 202-851-5/ 100-42-5 UR UR UR UR UR UR UR UR UR UR 5

Organotin compounds - UR UR UR UR UR UR UR UR UR UR 0.00

5 Tetrahydrofurfuryl Methacrylate

219-529-5/ 2455-24-5

UR

UR

UR

UR

UR

UR

UR

UR

UR

UR

0.5

Toluene 203-625-9/ 108-88-3 UR UR UR UR UR UR UR UR UR UR 5

Trans-1,3-dichloropropene

626-466-0/ 10061-02-

6



201-067-0 /

77-90-7

UR UR 2,0- 2.8 UR 7,4-

8.5 UR UR UR UR UR 0.5

Vinyl acetate 203-545-4 /

108-05-4


45

Chemical substance

EC no. / CAS no.

1 2 3 4 5 6 7 8 9 10 RL

ε-Caprolactam 203-313-2 /

105-60-2

UR UR UR UR UR UR 2,7- 3.2

UR- 0.6 UR UR 0.5

The results show that of the 47 chemical substances quantitatively analysed in panty liners, 13 substances were found in low concentrations37 (see more about the health risk assessment in chapter 4). Only formaldehyde and abietic acid were found in all panty liners.

Tampons The table below shows the results of the quantitative chemical analyses of tampons. The selection of substances is based on the previous screening analysis and literature study (see chapters 2.4 and 2.5).

Table 12. Concentrations of quantitatively analysed chemical substances in tampons (mg/kg). RL denotes the reporting limit and is individually specified for each substance in mg/kg. UR means that the quantity is under the reporting limit.

Chemical substance

EC no. / CAS no.

1 2 3 4 5 6 7 8 9 10 RL



5


219-371-7 / 2425-79-8

UR

UR -

0,71

0.58 -

0.73

UR

UR

0.7 4- 0.9 4

UR -

0.5 6

UR

UR

UR

0.5

1,4- bis[(vinyloxy)methyl] cyclohexane

413-370-7 / 17351-75-6

UR

UR

UR

UR

UR

UR

6,0- 6.4

UR

UR

UR

2

1-Ethyl-2-pyrrolidone

220-250-6 / 2687-91-4

UR

UR

UR

UR

UR

UR

UR

UR

UR

UR

0.5



2,3-Dichloropropene


2,3-Xylenol 526-75-0 UR UR UR UR UR UR UR UR UR UR 0.0 5


5


5


5


203-080-7 / 103-11-7 UR UR UR UR UR UR UR UR UR UR 0.5


5

37 Low concentrations are defined in this report as below 0.1 per cent weight by weight.

46

Chemical substance

EC no. / CAS no.

1 2 3 4 5 6 7 8 9 10 RL

Abietic acid 208-178-3 / 514-10-3 UR UR UR UR UR UR UR UR UR UR 0.0

5

Adipic acid 204-673-3 / 124-04-9 UR UR UR UR UR UR UR UR UR UR 0.1

Acrylamide 201-173-7 / 01/06/1979 UR UR UR UR UR UR UR UR UR UR 0.1

Arsenic and its compounds - UR UR UR UR UR UR UR UR UR UR 8

Butyl methacrylate 202-615-1/ 97-88-1 UR UR UR UR UR UR UR UR UR UR 10

Cis-1,3- Dichloropropene



205-463-4 / 141-16-2

UR

UR

UR

UR

UR

UR

UR

UR

UR

UR

5

Diantimony trioxide

215-175-0 / 1309-64-4

74- 81

69 - 72-

38- 43 UR UR UR 98-

104 28- 35

38- 45

48- 49 10

Dibutyl phthalate 201-557-4 / 84-74-2 UR UR UR UR UR UR UR UR UR UR 0.5

Diisobutyl phthalate


Dichlofluanid (ISO)


Dimethylacetamide



310-154-3/

121158-58-5 UR UR UR UR UR UR UR UR UR UR 5

Fensulfothion (ISO)


Formaldehyde 200-001-8 /

50-00-0

12- 13

1,0- 1.2

3,5- 3.5

3,7- 4.1

1,8- 1.9

0.8 5- 0.8 6

3,1- 3.3

1,6- 1.8

2,8- 3.3

1,1- 1.4

0.5

Glutaraldehyde 203-856-5/

111-30-8

UR

UR

UR

UR

UR

UR

UR

UR

UR

UR

0.2

Glyphosate 213-997-4/ 1071-83-6 UR UR UR UR UR UR UR UR UR UR 0.1

Hexafluorobenzene

204-273-9/ 118-74-1

UR

UR

UR

UR

UR

UR

UR

UR

UR

UR

0.1

Isopropyl alcohol 200-661-7 / 67-63-0 UR UR UR UR UR UR UR UR UR UR 50



Quintozene (ISO) 201-435-0/ 82-68-8 UR UR UR UR UR UR UR UR UR UR 0.1

Limonene 205-341-0/ 138-86-3 UR UR UR UR UR UR UR UR UR UR 0.5

Malathion (ISO) 204-497-7/ 121-75-5 UR UR UR UR UR UR UR UR UR UR 0.1

47

Chemical substance

EC no. / CAS no.

1 2 3 4 5 6 7 8 9 10 RL

Methidathion (ISO)


Methylisothiazolinone


N,N- dimethylformamide

200-679-5/ 02/12/1968 UR UR UR UR UR UR UR UR UR UR 0.5


246-680-4/ 25155-30-0 UR UR UR UR UR UR UR UR UR UR

30

Neo-decanoic acid

248-093-9 / 26896-20-8 UR UR UR UR UR UR UR UR UR UR 0.1

Piperonylbutoxide 200-076-7/ 06/03/1951 UR UR UR UR UR UR UR UR UR UR 0.1

Prallethrin (ISO) 245-387-9/ 23031-36-9 UR UR UR UR UR UR UR UR UR UR 0.1

Procymidone 51-233-1/ 32809-16-8 UR UR UR UR UR UR UR UR UR UR 0.1

Pyrethrin I 204-455-8/ 121-21-1 UR UR UR UR UR UR UR UR UR UR 0.1

Styrene 202-851-5/ 100-42-5 UR UR UR UR UR UR UR UR UR UR 5

Organotin compounds - UR UR UR UR UR UR UR UR UR UR 0.0

05

Tetrahydrofurfuryl

Methacrylate 219-529-5/ 2455-24-5

UR

UR

UR

UR

UR

UR

UR

UR

UR

UR

0.5

Toluene 203-625-9/ 108-88-3 UR UR UR UR UR UR UR UR UR UR 5

Trans-1,3-dichloropropene



201-067-0 /

77-90-7

UR

UR

UR

UR

0.6 6- 0.9 2

UR

UR

UR

4,6- 5.1

UR

0.5

Vinyl acetate 203-545-4 / 108-05-4 UR UR UR UR UR UR UR UR UR UR 10

ε-caprolactam 203-313-2 / 105-60-2 UR UR UR UR UR UR UR UR UR UR 0.5

The results show that of the 52 chemical substances quantitatively analysed in tampons, five substances were found in low concentrations38 (see more about the health risk assessment in chapter 4). Only formaldehyde was found in all tampons.

Menstrual cups The table below shows the results of the quantitative chemical analyses of menstrual cups. The selection of substances is based on the previous screening analysis and literature study (see chapters 2.4 and 2.5). Menstrual cups 3 and 4 are made from thermoplastic elastomer (TPE), unlike the others which are made of silicone. Menstrual cups 3 and 4 gave no 38 Low concentrations are defined in this report as below 0.1 per cent weight by weight

48

indication of substances D4, D5, D6, D7, D8 and D9 in the screening analysis (see table 5 for the complete substance names), and were therefore not analysed for these substances in the quantitative analysis. The screening analysis did not detect substances D7 and D8 in menstrual cup 7, and we therefore did not include these in our quantitative chemical analysis. In the screening analysis we only found benzophenone in menstrual cup 8, and we therefore limited analysis of this substance to only this cup.

Table 13. Concentrations of quantitatively analysed chemical substances in menstrual cups (mg/kg). RL denotes the reporting limit and is individually specified for each substance in mg/kg. UR means that the quantity is under the reporting limit. In cases where a substance has not been analysed in the sample (marked with ”-”), it has been assessed that the analysis is not relevant to the product, for example because the product does not contain materials where the substance in question is normally found or because our screening analysis has shown that the substance is not present in the product.

Chemical substance EC no. / CAS no. 1 2 3 4 5 6 7 8 RL

Benzophenone 204-337-6/ 119-61-9

- - - - - - - 740-750

10

Decamethylcyclopentasiloxane, D5

208-764-9 / 541-02-6

1,5-1.6

2,0-

2.0 - - 1,8-

1.8 3,7-4.0

740-740

1,6-1.6 1

Decamethylcyclononasiloxane, D9

- / 556-71-8

76-80

160-

170 - - 5,6-

5.7 57-60

740-760

12,0-12.0 1


208-762-8 / 540-97-6

8,5-8.8

1,7-1.7 - - 2,2-

2.2 5,6-5.8

1900-

2000

2,8-2.9 1

Hexadekamethylcyclooctasiloxane, D8

209-137-2 / 556-68-3

33-35

47-50 - - 2,6-

2.8 26-27 - 5,8-

6.1 1


209-136-7 / 556-67-2 UR UR - - UR UR 88 -

89 UR 1

Organotin compounds - UR UR UR UR UR UR UR UR 0.00

5

Tetradecamethylcycloheptasiloxane, D7

203-496-9 / 107-50-6

23-23

7,7-8 - - 2,3-2.5

15-15 - 4,9-

4.9 1

The results show that of the eight chemical substances quantitatively analysed in menstrual cups, seven substances were found in concentrations above the reporting limit (see more about the health risk assessment in chapter 4). Most of the substances were found in the majority of the products. The TPE menstrual cups (numbers 3 and 4) did not return any hazardous chemical substances in the screening nor in the quantitative analysis. The concentrations are generally low39. Compared to the other menstrual cups, numbers 7 and 8 contain higher concentrations of one or more chemical substances.

39 Low concentrations are defined in this report as below 0.1 per cent weight by weight. One of the substances, D6, was detected at 0.2 per cent weight by weight in menstrual cup number 7.

Appendix 3 – IVL’s report to the Swedish Chemicals Agency Survey of hazardous substances in feminine hygiene products in Sweden

Preface The government has commissioned the Swedish Chemicals Agency to conduct a survey of

the presence of hazardous substances in products and articles that are not yet restricted within

the EU. The survey will primarily focus on substances of very high concern, but may also

cover hazardous substances where relevant to the protection of human health and the

environment. The Government’s budget for 2017 includes feminine hygiene products as an

example of a product group that should be included in the commission.

IVL has carried out this general survey on behalf of the Swedish Chemicals Agency in order

to identify the substances and substance groups that are relevant to include in a later

quantitative analysis of feminine hygiene products.

Contents Summary .................................................................................................................... 4

1 Introduction .................................................................................................... 5

2 Literature study .............................................................................................. 5 2.1 Search procedures and sources ................................................................................................ 5 2.2 Results of the literature study ..................................................................................................... 6 2.2.1 Products and materials .............................................................................................................. 6 2.2.2 Hazardous substance contents .................................................................................................. 8

3 Identification of potentially relevant substances in the PC product group 39: Cosmetics and Personal Care Products ............................................. 19

4 Screening ..................................................................................................... 19 4.1 Methodology ............................................................................................................................ 23 4.2 Results .................................................................................................................................... 24

5 Conclusions and discussion ...................................................................... 25

6 Bibliography ................................................................................................. 30

Appendix 1: Substances that may be present in feminine hygiene products based on

the reviewed literature

Appendix 2: Results of Swiss study

Appendix 3: Hazardous substances that may be present in feminine hygiene products based on

registration in user sector in REACH Annex XV and information about the hazard

posed by the substance

Appendix 4: Substances identified in quantitative analysis

Appendix 5: Substances occurring in more than one of the lists (Appendices 1, 3, 4)

Appendix 6: List of proposed substances for quantitative analysis

4

Summary A general survey of the substances and substance groups that are relevant to include in

a subsequent quantitative analysis of feminine hygiene products has also been carried

out.

The product group includes sanitary towels, panty liners, tampons and menstrual cups, mainly

made from cellulose/cotton and rubber-like materials such as silicone, thermoplastic elastomer

and latex.

The work has included a literature study and a qualitative laboratory analysis (screening

analysis) of potential substances in 35 product samples. The survey has also identified the

potential existence of hazardous substances through a search of relevant databases. The report

presents the results from each part in the form of lists of substances in the appendices. The

documentation produced in these three steps has been used to then compile a list of proposed

substances to include in quantitative chemical analyses.

Literature in the form of academic publications, reports and online news articles showed

that there is limited information available about chemical substances in feminine hygiene

products. Several documents refer back to a small number of published studies.

The purpose of the identified articles has mainly been to quantify substances that can be

suspected to feature and which are deemed to be hazardous in other contexts.

The recorded concentrations are mostly low.

The final result is a list of 36 proposed substances/substance groups that should be included in

quantitative chemical analyses and determination of concentrations.

5

1 Introduction Work in this survey consisted of a literature study and a qualitative chemical analysis

(screening) of 35 product samples. The survey has also identified potentially hazardous

substances through a search of relevant databases. The produced documentation has been used

to compile a list of proposed substances to include in quantitative chemical analyses.

The product group in question includes sanitary towels, panty liners, tampons and menstrual

cups, mainly made from cellulose/cotton and rubber-like materials such as silicone,

thermoplastic elastomer and latex.

The survey includes both substances which are restricted and substances that are not yet

restricted within the EU.

According to the assignment, CMR substances, endocrine disrupting, allergenic and

environmentally hazardous substances (e.g. PBT substances) shall be prioritised. Substances

which can be allergenic or sensitising in scented products and products with “odour control”

are also of interest. Pesticide residues have also been included in the study.

2 Literature study The literature study includes a review of articles in public academic literature, consumer

tests, tests and surveys conducted by other government agencies, interest groups or

consumer organisations in Sweden and abroad, and ecolabelling criteria for feminine

hygiene products.

This section describes the search procedure followed by a summary of results from the

literature study.

The results begin with a general description of the tested hygiene products.

It is followed by a summary of the levels of hazardous substances detected, as identified

in the literature study. The first part of the summary includes substance groups such as

dioxins and various pesticides for which most information was found in the literature

study. The second part presents other “hazardous” substances/substance groups noted in

the literature study.

It also includes a description occurrence of substances included in the criteria

document for Nordic ecolabelling of hygiene products.

All substances identified in the literature are listed along with their CAS numbers in Appendix 1.

2.1 Search procedures and sources Searches for scientific articles were made in the databases Web-of-Science, PubMed and

ScienceDirect. Searches were also made for publicly available materials in the form reports,

summaries and news articles on Google. The Swedish Chemicals Agency has provided

materials collected before this survey.

The following keywords were used when searching:

bindor, tamponger, menskopp & kemikalier, kemiska ämnen

mensskydd & kemikalier, kemiska ämnen

intimhygienprodukter & kemikalier, kemiska ämnen

6

feminine hygiene products & chemicals, chemical compounds

sanitary pads, tampons & chemicals, chemical compounds

Literature in the form of academic publications, reports and online news articles showed

that there is very limited information available about chemical substances in feminine

hygiene products. The majority of documents refer back to a small number of published

studies.

Discovered articles have mainly concerned studies carried out to quantify substances that can

be suspected to feature and which are deemed to be hazardous in other contexts. The recorded

concentrations are mostly low.

Below are the results of the literature review. The literature review gives an indication of

what chemical substances could be searched for when screening sanitary towels, tampons,

panty liners and menstrual cups. Unfortunately, no published results regarding the occurrence

of hazardous substances in menstrual cups has been found.

2.2 Results of the literature study

2.2.1 Products and materials

Table 1 shows examples of various types of materials that feature in the product groups

included in this study.

Table 1: Primary materials in feminine hygiene products

Product group Material Source

Tampons Core Surface

treatment

String 1

Cotton, rayon or

mix

Rayon fibres Cotton

Viscose Cotton

Viscose and Cotton

Sanitary towels Superabsorbents (SAP, Sodium polycarbonate as

granules or fibres) nonwoven

2,3

Panty liners Cellulose 4

Menstrual cups Silicone, rubber or plastic 5

Some explanatory schematics of the products’ structures can be found in the following figures3.

7

Figure 1: Structure of a sanitary towel.3

Figure 2: Structure of panty liner.3

Figure 3: Structure of tampon.3

8

Figure 4: Illustration of some products

2.2.2 Hazardous substance contents

A summary of identified hazardous substances from the literature study can be found in Appendix 1.

Internet searches provide a large number of news items and popular science articles regarding

hazardous substances in feminine hygiene products. The news articles often contain the same

information as they cite each other. The more popular science-style articles and consumer

surveys generally talk about how there may be hazardous chemicals and the type of chemicals

that this may be. The scientific articles and certain government agency reports present

analysis methods and recorded concentrations.

A general overview of possible toxic chemicals in feminine hygiene products is presented in a

scientific article published within a network organisation, Women’s Voice for the Earth

(Scranton, 2013)6. Mucous membranes and the vagina are routes of exposure to chemicals as

chemicals absorbed via the vagina are distributed throughout the body without being

metabolised. The article mentions health issues such as itching, irritation and infections. The

article also briefly explains which substances and substance groups may be found in several

different products aimed at women (not just menstruation-related products) such as tampons,

sanitary towels, wet wipes and rinsing agents, deodorants, and anti-itch creams.

Similar information regarding feminine hygiene products, vaginal absorption of (hazardous)

chemicals, types of chemicals, and percentage of women using the various sanitary products can be found in another scientific article (Nicole, 2014)7.

The majority of the literature concerning chemicals in feminine hygiene products focuses

on dioxins, which is a collective term for two substance groups: polychlorinated

dibenzodioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs).

Pesticides have also been examined in the literature as it was suspected that they

may be found among feminine hygiene products.

The published works all have specific hazardous substances that they focus on. In many of

the identified studies, the purpose has been to identify the occurrence of known hazardous

substances/substance groups such as dioxins, polycyclic aromatic hydrocarbon (PAH),

phtalates, formaldehydes which can potentially be toxic, carcinogenic or interfere with

endocrine functions.

Another source used to identify chemical substances in sanitary products including feminine

hygiene products is the criteria description for Nordic ecolabelling of these products.

Substances mentioned in this document are summarised in a separate section below.

Finally, IVL has contacted the industry organisation EDANA and manufacturers of feminine

hygiene products with questions about their procedures for evaluating the occurrence of

(hazardous) substances in products, and how these occurrences are detected. Examination of

finished products is mainly done in the form of toxicological, clinical, microbiological,

gynaecological, and dermatological examinations. Analyses of individual chemical

substances are not normally carried out8.

Dioxins: Polychlorinated dibenzodioxins (PCDDs) and Polychlorinated dibenzofurans

(PCDFs)

Dioxins is the group of hazardous chemicals that has been most frequently and extensively

analysed and reported on in the literature. Most feminine sanitary products contain rayon,

cotton, or a rayon/cotton mix, see table 1. Rayon and cotton are both cellulose-based, and the

difference between them is the degree of cellulose polymerisation. Cellulose

is refined through a bleaching process which used to involve chlorine gas (Cl2). PCDDs and PCDFs can arise as by-products when bleaching cellulose (Scialli, 2001)9

and these substances can therefore feature in feminine hygiene products such as tampons. The use of chlorine gas for bleaching has been substituted by chlorine dioxide (ClO2) or sodium hypochlorite (NaClO) which has resulted in a significant drop in the formation of dioxins and furans (PCDD/Fs)10.

Researchers at the U.S. Food and Drug Administration (FDA) analysed the dioxin content

in seven brands of tampons. 2,3,7,8-tetrachlorodibenzofuran was detected in one brand, while heptachlorodibenzo-p-dioxin and octachlorodibenzo-p-dioxin were detected in

several brands10.

The analysis method is described in detail in the article. Based on the concentrations

presented here, a risk assessment was made regarding dioxin intake from tampon use (within

the aforementioned study). The U.S. Joint Expert Committee on Food Additives (JECFA) has

established a preliminary tolerable monthly intake of 70 pg/kg of body weight (per month).

Assuming that: all dioxin in the tampon is absorbed by the body; the highest dioxin content

(in one brand 0.225 pg/tampon); the use of 24 tampons per month and a woman’s

hypothetical weight of 50 kg, the theoretical exposure is equal to 5.4 pg/month or 0.108 pg/kg

of body weight per month. This corresponds to less than 0.2 per cent of the tolerable monthly

intake set by the JECFA.

U.S. In another document, the FDA recommends that tampons be free of 2,3,7,8-

tetrachlorodibenzo-p-dioxin (TCDD)/2,3,7,8-tetrachlorofuran (TCDF) and any pesticide rests (FDA, 2005)11. However, this is not an obligatory recommendation.

10

A B C D

DeVito and Schecter (2002)12 tested for 17 chlorinated dibenzo-p-dioxins and dibenzofurans

in various tampon brands. Substances over detection limits (0.1–0.2 pg/g) and their levels in

tampons are shown in Table 2.

Table 2: Detected concentrations of dioxins in tampons (DeVito and Schecter, 2002)12. The unit is pg/g.

Dioxin compounds

Brand A

Brand Brand Brand Brand

(rayon) (cotton)

1,2,3,4,6,7,8-Hexachlorodibenzo-p-

dioxin

0.2

0.4

2.1

0.8

0.7

Octachlorodibenzo-p-dioxin 0.9 2.2 20.7 7.5 3.7

2,3,7,8-Tetrachlorodibenzofuran 0.1 0.1 0.1 0.1 0.6

1,2,3,7,8-Pentachlorodibenzofuran <0.1 <0.1 <0.1 <0.1 0.4

2,3,4,7,8-Pentachlorodibenzofuran <0.1 <0.2 <0.1 <0.1 0.2

All hexachlorodibenzofurans <0.1 <0.1 <0.1 <0.1 0.5

All heptachlorodibenzofurans 0.1 0.1 0.1 0.1 0.4

Octachlorodibenzofuran 0.2 0.3 0.6 0.2 1.2

Total dioxins (pg/g) 1.5 3.1 23.6 8.7 7.7

The dioxin concentrations in tampons recorded by DeVito and Schecter (2002) were

converted into TEQ (Toxic Equivalents) and the daily intake of dioxins in the body from

tampons (as TEQ/kg/day) was compared to the dioxin intake from food and drink. The

conclusion was that exposure to dioxins from tampons is ~100–1,000 times lower than

exposure through food and drink.

Dioxins (PCDD and PCDF) have been analysed in sanitary towels and tampons from Korea,

Japan, USA, Germany and China (Shin and Ahn, 2007)13. Two different solvents for

extracting dioxins from the material were tested; a mix of hexane/dichloromethane (1/1)

yielded better results than toluene. In total, 17 dioxins were tested for according to a WHO

method i. The total number of detected dioxins (8 out of 17) in the sanitary towels varied

between 3.0 pg/g and 24 pg/g, of which 79–100 % of the total amount consisted of octa-

chlorinated dioxins and furans (OCDD and OCDF). The total amount of detected dioxins (10

out of 17) in the tampons (Korea, Japan and USA only) varied between 0.24 pg/g and 14

pg/g, where the most abundant dioxins were octa-chlorinated dioxins/furans.

The results of the tests are shown in Tables 3 and 4. The detection limit is not specified in the original

article.

i reference in the bibliography in the article

11

Table 3: Levels of PCDD and PCDF in sanitary towels in pg/g.

PCDD/Fs K1 K2 K3 J1 J2 J3

1,2,3,7,8-PeCDD N.D. N.D. N.D. N.D. N.D. N.D.

1,2,3,4,7,8-HxCDD N.D. N.D. N.D. N.D. N.D. N.D.

OCDD 2.45 1.80 N.D. 8.85 3.18 5.11

2,3,7,8-TeCDF N.D. N.D. N.D. N.D. N.D. N.D.

1,2,3,4,7,8-HxCDF 0.67 0.34 N.D. 0.36 0.13 0.77

1,2,3,6,7,8-HxCDF 0.25 0.16 N.D. N.D. N.D. N.D.

2,3,4,6,7,8-HxCDF 0.35 N.D. N.D. N.D. N.D. N.D.

OCDF 2.31 1.46 N.D. 14.30 3.78 13.87

Total (pg/g) 6.0 3.8 24 7.1 20

PCDD/Fs

U1

U2

G1

G2

C1

C2

1,2,3,7,8-PeCDD N.D. N.D. N.D. N.D. 0.28 4.36

1,2,3,4,7,8-HxCDD N.D. N.D. N.D. N.D. 0.21 2.54

OCDD N.D. N.D. 3.10 4.90 1.10 2.50

2,3,7,8-TeCDF N.D. N.D. N.D. N.D. 2.12 N.D.

1,2,3,4,7,8-HxCDF N.D. N.D. N.D. N.D. N.D. N.D.



OCDF N.D. N.D. N.D. N.D. N.D. N.D.

Total (pg/g) 3.0 4.9 3.7 9.4

K = Korea, J = Japan, U = USA, G = Germany, C = China; N.D. = not detected

Table 4: Levels of PCDD and PCDF in tampons in pg/g.

PCDD/Fs TK1 TJ1 TJ2 TU1 TU2 TU3

1,2,3,7,8-PeCDD N.D. N.D. N.D. 0.57 0.31 0.21

1,2,3,4,7,8-HxCDD N.D. 0.25 N.D. 0.82 0.12 0.01

1,2,3,4,6,7,8-HpCDD 0.34 0.25 N.D. 0.57 N.D. N.D.

OCDD 2.61 2.74 1.77 8.15 1.69 0.00

2,3,7,8-TeCDF N.D. 0.34 N.D. N.D. N.D. N.D.

1,2,3,4,7,8-HxCDF 0.20 0.44 0.13 0.37 0.11 0.01

1,2,3,6,7,8-HxCDF 0.07 0.22 0.10 0.32 0.07 0.02

2,3,4,6,7,8-HxCDF N.D. N.D. N.D. 0.43 0.16 N.D.

1,2,3,4,6,7,8-HpCDF 0.31 0.41 N.D. 1.07 N.D. N.D.

OCDF 0.62 3.38 N.D. 1.39 0.81 N.D.

Total (pg/g) 4.1 8.0 2.0 14 3.3 0.24

K = Korea, J = Japan, U = USA

The dioxin contents were similar in sanitary towels and tampons, while there were

differences based on country of origin. The article provides no information about how the

products and countries of origin were selected, only stating that Korean products were

compared to foreign product. The most potent dioxins 2,3,7,8-tetrachlorodibenzo-p-dioxin

(TCDD) and 1,2,3,7,8-pentachlorodibenzo-p-dioxin are claimed to exist in high

concentrations only in the Chinese sanitary towels (C1 and C2 in Table 3), but TCDD for

example is not reported in any of the tables in the article. No discussion is presented

regarding the difference substance concentrations in the products from the different countries.

12

A literature study regarding the risk of dioxin exposure from the use of tampons, based on

scientific articles (including DeVito and Schecter, 2002; Shin and Ahn, 2007) was carried out

at Lund University (thesis Lundqvist, 201414). This study uses recorded concentrations of

dioxins and specified Toxic Equivalents to model dioxin intake from tampons. The results are

compared for women who only use tampons and those who use other protection, as well as

between women whose only dioxin intake is via food and drink and those who receive it from

tampons as well. The conclusions of this study are that

the risk of expose to dioxins in tampons at the detected levels is negligible

the risk of the monthly intake exceeding the set limits is not affected by whether

or not a person uses tampons

the government agencies’ decision not to inspect sanitary products more closely for

dioxins is correct

In a Swiss study (2016)15 the concentrations of 17 dioxins were tested in 8 tampons and 8

sanitary towels. This study also included polycyclic aromatic hydrocarbon (PAH, 16

substances), phtalates (8 substances), formaldehyde and the pesticides glufosinate, glyphosate

and AMPA (a degradation product of glyphosate). The dioxin results can be found in

Appendix 2, Tables 2:1 and 2:2. The results for other substances in this study can be found

below in the next section. This study includes no information about the analysis methods.

The dioxin concentrations (total detected dioxins converted into Toxic Equivalents) were

within the interval (4 – 1,120) × 10-5 pg TEQ/gram material. The total concentrations (as

TEQ) were generally higher in tampons than in sanitary towels. An estimated dioxin intake

from feminine hygiene products based on this study is 2,600 times lower than the intake from

food and drink.

As the above studies have concluded that exposure to dioxins from the use of tampons is

negligible, feminine hygiene products would not need testing for these particular chemicals.

However, the dioxin concentrations in these products can differ between brands and between

types of hygiene products.

Pesticides

Another group of chemical substances linked to cotton are (rests of) pesticides used in cotton

production. Pesticides is the second most commonly reported group of hazardous chemicals in

feminine hygiene products according to the literature review.

Pesticides in sanitary towels were the subject of a Danish study (Miljøstyrelsen, 2002)16.

Samples from sanitary towels (5 items, anonymised) were extracted in methylene chloride

and derivatised; samples were analysed using gas chromatography/mass spectrometry

(GC/MS) or gas chromatography/electron capture detection (GC/ECD). The tests were done

using duplicate analysis. The substances included in the study are presented in Table 5 below

along with the analysis method’s detection limits.

13

Table 5: Pesticides in the Danish study with associated detection limits.

Pesticide Detection limit µg/g

Aldrin 0.02

Atrazine 0.01

Camfechlor (toxaphen) 0.04

Cyflurthrin 0.03

2,4-D 0.01

DDT 0.01

Diazinon 0.01

Dichlorvos 0.01

Dieldrin 0.01

Dicofol 0.02

Endosulfan 0.02

Endrin 0.05

Fluazifop butyl 0.01

Fenvalerat 0.02

Heptachloropoxid 0.01

Hexachlorobenzene 0.01

Captan 0.01

Carbaryl 0.02

Quintozen 0.01

Lambdacyhalothrin 0.03

Methoxychlor 0.01

Pentachlorophenol 0.01

Permethrin 0.01

Pirimicarb 0.01

Simazine 0.01

2,4,5-T 0.01

Trifluralin 0.01

No pesticides in Table 5 could be detected in quantities above the detection limit in sanitary pad

samples.

One brand of tampons, o.b., was tested for pesticides by a non-specified laboratory, without

information about the analysis method, and presented in the general article by Scranton

(2013)6. The article notes that the concentrations are generally low and mostly under the

residual values allowed in foodstuffs. The results of the test are shown in Table 6.

14

Table 6: Pesticides in o.b. tampon. Unit: ppmii:

Pesticide content

Malaoxon &

Malathion

1 ppm

Dichlofluanid 1 ppm

Mecarbam 6 ppm

Procymidone 37 ppm

Methidathion 5 ppm

Fensulfothion 5 ppm

Pyrethrum 66 ppm

Piperonyl Butoxide 1 ppm

In the autumn of 2015, the results of a study where the concentration of glysophates in

tampons, sanitary towels and other hygiene products made from cotton and/or rayon were

presented (Damián Marino at the university in Mar del Plata, Argentina17). The study

garnered significant international attention. Glyphosate is the most commonly used herbicide

in the world and is the active substance in “Roundup”, the world’s best-selling weedkiller.

The news article claims that 85 % of the products tested by the researcher contained

glyphosate (N- (phosphonomethylglycine) and that 62 % contained AMPA

(aminomethylphosphonic acid), a degradation product of glyphosateiii. Information from

another online news article (The Detox Project 2015–2017)18 shows that the concentrations

were 39 ppb (ng/g) of AMPA and 13 ppb (ng/g) of glyphosate in raw cotton and only 17 ppb

(ng/g) of glyphosate in gauze.

The study of glyphosate in tampons and sanitary towels is not academically published, so

there is no information about its scientific quality. The same researcher (D. Marino) has

published an article on the concentrations of glyphosate and AMPA in soil, with a thorough

description of the analytical method consisting of extraction, addition of an radio-labelled

internal standard, analysis using LC/MSMS and establishment of LOQ: 1 ng/g.

If the results of the news article (The Detox Project 2015–2017)18 concerning glyphosate

concentrations in tampons and sanitary towels are correct, this means that the glyphosate

concentrations are around 1,000 times lower than the concentrations of other pesticides presented in Scranton’s article.6

In the Swiss (2016) study15, the glyphosate and AMPA concentrations were both below 10

ng/g (probably the detection limit) in all tested tampons and sanitary towels with the exception

of one brand of sanitary towel where AMPA was detected at 32 ng/g (Appendix 2, Tables 2:5

and 2:6). Even this “extreme” level (compared to other products), is expected to result in

250,000 times less exposure than the tolerable daily intake.

Substances included in few studies

This section describes substances and substance groups that are only included in occasional

publications. A number of other substances or substance groups were presented in the 201615

Swiss study which included 8 brands of tampon and 8 brands of sanitary towel. The results of

this study are available as a downloadable Excel document on the specified website, however

without information about

ii We presume that this means µg/g

iii The result has here been interpreted as the percentages refer to all tested products, i.e. including other

hygiene products such as cotton pads, swabs and gauze in addition to sanitary towels and tampons.

15

the analysis methods. In addition to dioxins and named pesticides, there are also results for

PAHs (16 PAH components), formaldehyde and phtalates (8 substances). A list of the results

can be found in Appendix 2, Tables 2:1 – 2:6.

Formaldehyde was not detected (detection limit; < 5 µg/g for tampons and < 20 µg/dm2 for

sanitary towels).

Diisobutyl phthalate (DiBP), di-n-butyl phthalate (DnBP), Benzyl butyl phthalate (BBzP)

and diethylhexyl phthalate (DEHP), all of which are controlled substances, were not detected

in any of the samples (detection limit of 1 µ g/g). The other 4 phthalates included in the

study were diisopentyl, di-n-pentyl, di-n-hexyl- and dimethoxyethyl phthalate. These were

also not found in the samples.

The U.S. Environmental Protection Agency (EPA) has classified 16 PAHs as ”priority

PAHs”iv. The reason for this is that they are common in the environment and that 12 of them

have toxic relevance (Toxic Equivalent Factor, TEF value). The total concentration of 16

PAH in this study varied between 20 and 2,300 ng/g. The tampons had a lower total amount

of PAH, which varied between 21 and 58 ng/g) compared to the sanitary towels where the

total amounts varied between 12 and 563 ng/g, with one extreme value of 2,334 ng/g. The

exposure dose from the sanitary towel with the highest level of PAH was estimated to be 23

times lower than the average daily intake of PAH through food and drink17.

The Women’s Voice for Earth interest organisation tested Always sanitary towels for

concentrations of volatile organic compounds19. The analyses were carried out by a certified

laboratory STAT Analysis Corporation with the aid of head-space/GC/MS technology and in

accordance with EPA Method TO-15 for analysing volatile organic compounds. Two scented

and two unscented sanitary towels of different brands were tested. The results can be found in

Table 7.

The amounts are specified in parts per billion per volume (ppbv) which is a unit that is used

for gas/air and not materials. The analysis results show how much of the various substances

that are emitted by the samples during the analysis; they can therefore be considered semi-

quantitative and only be used to compare samples to each other.

Table 7: Volatile organic compounds in “head-space” over sanitary towels. The unit is

ppbv, i.e. amount in analysis vial.

Product

Chemical compound

Clean Scent

Always Ultra

Thin ppbv

Unscented

Always Ultra

Thin ppbv

Clean Scent

Always

Radiant ppbv

Unscented

Always

Infinity ppbv

1,2,4- Trimethylbenzene

0.64

0.54

n.d.

1.2

1,3,5- Trimethylbenzene

n.d.

n.d.

n.d.

0.54

2-Butanone 7.5 7.7 n.d. 4.2

4-Ethyltoluene n.d. n.d. n.d. 0.46

Acetone 480 340 92 93

iv

16 PAH compounds which have been prioritised by both the American and Swedish EPAs, and which are

normally checked for. The 16 prioritised PAH compounds are naphthalene, acenaphthene, acenaphthylene,

fluorene, phenanthrene, anthracene, fluoranthene, pyrene, phenanthrene, benzo(a)anthracene, chrysene,

benzo(b)fluoranthene, benzo(k)fluoranthene, benzo(a)pyrene, dibenz(ah)anthracene, benzo(ghi)perylene, and

indeno(123cd)pyrene. These 16 PAHs are often analysed as a package and the amount is presented as total PAH

16.

16

Product

Chemical compound

Clean Scent

Always Ultra

Thin ppbv

Unscented

Always Ultra

Thin ppbv

Clean Scent

Always

Radiant ppbv

Unscented

Always

Infinity ppbv

Chloroethane n.d. n.d. 4.4 6.1

Chloroform 1.2 1.5 n.d. n.d.

Chloromethane n.d. n.d. n.d. 16

Cyclohexane 0.5 0.78 n.d. 1.1

Ethyl acetate 8 5.5 n.d. 2.3

Ethylbenzene n.d. 0.52 n.d. 0.84

Heptane 1.1 1.5 n.d. 0.86

Isopropyl alcohol 170 39 n.d. 17

m,p-Xylene 1.4 2 n.d. 2.8

o-Xylene 0.54 0.68 n.d. 1.5

Styrene 0.44 n.d. n.d. 1.1

Toluene 3.2 6.2 n.d. 7

trans-1,2-

Dichloroethene

n.d.

0.5

26

n.d.

Vinyl acetate 14 n.d. n.d. 6.6 n.d. not detected

Individual substances could not be traced to parts of products. One complicating factor is that

no fragrance substances are presented for the scented (Clean Scent) versions of the samples. It

is not stated whether the study has attempted to measure the fragrance substances. Most

substances in Table 7 feature in normal indoor air.

In 2016 the magazine Råd & Rön conducted an extensive test of 15 tampon brands, checking

for phtalates, heavy metals, organic tin compounds, azo dyes, PAH, adsorbable organically

bound halogenes (AOX), the pesticide glyphosate and the degradation product of glyphosate

(AMPA)20. Residual AOX was detected in all products, but without subject-specific

information, and residual glyphosate and AMPA in one product. The tampons were

otherwise free of extractable chemicals. There is no information about specific substances, no

numerical information about substance concentrations, nor information about analysis

methods.

In addition to pesticides, the study conducted by the Danish Environmental Protection

Agency16 also included rosin and a number of acrylates (Methacrylate, Ethyl acrylate, Butyl

acrylate, Butyl methacrylate, Tert- butyl acrylate, Ethylene diacrylate, Ethylhexyl

methacrylate, Hydroxypropyl acrylate, 1,6-Hexanediol diacrylate, Diethylene glycol

diacrylate), which were measures in five tampon brands. None of the substances were present

above the detection limit (0.4 µg/g). This study found concentrations over the detection limit

of glyceryl tricaprylate in all samples (5.4 – 29 µg/g) and oleyl alcohol in one sample (150

µg/g).

Substances included in the criteria for Nordic Ecolabelling

In 1989 the Nordic Council decided to introduce a voluntary official ecolabel,

“Svanenmärket” (Nordic Ecolabelling). The document “About Nordic Ecolabelled Sanitary

products” describes the criteria for ecolabelling of sanitary products (sanitary towels,

tampons, panty liners)21 A large part of the document concerns Life Cycle Analysis (LCA)

as it quantifies the products’ environmental impact. The second part of the document

specified various requirements for chemical products and chemicals in these products. The

document does not describe which substances may feature in hygiene products aimed at

women, instead

17

discussing which substances disqualify a product from ecolabelling. The document

differentiates between substances and impurities; with the latter having a concentration under

100 ppm (µg/g). The requirements are divided into chemical requirements (general and

other) and material requirements (recycled materials, cellulose, paper, wood, cotton,

regenerated cellulose, polymers, superabsorbent polymers, nonwoven).

General chemical requirements in the criteria document Nordic Ecolabelling

The sanitary product group (sanitary towels, tampons, panty liners) may not contain

substances classified under CLP Regulation (EC) No 1272/2008 (Table 2, p. 38 of the

document). Other substances which may not occur in the products are:

Prohibited substances:

substances from the candidate list in REACH

organotin compounds

phthalates

APEO (alkylphenolethoxylates and other alkylphenol derivatives) –

substances that produce alkylphenol during degradation

halogenated organic substances

flame retardants

Prohibited substances with specific characteristics:

substances defined by EU as PBT (Persistent, Bioaccumulative and Toxic) or vPvB

(very Persistent and very Bioaccumulative)

substances that are potential endocrine disruptors and due to be tested

for endocrine disrupting effects

bioaccumulative preservatives

antibacterial substances such as nanosilver or triclosan

Fragrances, lotions and other additives (odorants, essential oils and plant extracts) may not

be added to sanitary products. “Odour control” substances are only allowed in incontinence

care products. Odorants are not specified on a substance level in the Nordic Ecolabelling

criteria document. If odorants are still used, they must meet the General chemical

requirements (above).

Material requirements in the criteria document

Below is an extract concerning specific chemicals from the criteria document’s material

requirements section. It is a summary of specific substances that are mentioned in the

criteria document and which may feature as process chemicals or additives when

manufacturing materials which in turn become part of the feminine hygiene products. It can

be interpreted as the aforementioned chemical substances being suspected of featuring in

the feminine hygiene products.

The chemical substances listed below are controlled, i.e. they may not be

included in the feminine hygiene products, through the General chemical

requirements section of the document.

Adhesive and binding agents must not contain phthalates and rosin (abietic acid); the

concentration of formaldehyde in dried adhesive may not exceed 10 ppm (µg/g).

Silicone must not contain solvent-based silicone deposits, the substances

octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) must not be

present; organotin catalysts may not be used in the manufacturing of silicone.

18

Polymers must not be halogen based (e.g. PVC). Halogenated organic compounds,

phthalates, organotin impurities and impurities of lead, cadmium, chromium (VI) and

mercury must not be present in polymers as anything other than impurities (see definition

above). In the production of polyurethane/elastane, organotin impurities and N,N-

Dimethylacetamide (DMAc) may not be used.

The following substances and substance groups are specified as suspected to be

present in the polymeric materials:

Arsenic and its impurities: e.g. 10,10’-oxybisphenoxarsine (OBPA) as an

atimictrobial additive in plastic. Relevant for plasticised PVC, PUR (polyurethane),

LDPE (low-density polyurethane) and polyester

Triclosan in PE (polyethylene), PP (polypropylene), PET (polyethylene

terephthalate), PA (polyamide), PVC

Organotin impurities, in polyurethane and PVC

2,2’-dichloro-4,4’-methylenedianiline (MOCA): most relevant to PU (cross-linker),

but also in polystyrene (hardener)

Diisobutyl phthalate (DIBP) in polystyrene

Pigments: based on lead, chromium, cobalt: relevant to coloured polymers

Antimony trioxide in polyester (PET)

Styrene in polystyrene

Caprolactam and adipic acid in polyamide

Dimethylacetamide (DMAc) and dimethylformamide (DMF) in elastane

The superabsorbent polymers (SAP) currently used in absorbent hygiene products are

primarily represented by sodium polyacrylate. Acrylamide must not be used as a monomer.

They may contain a maximum of 1,000 ppm (µg/g) of residual monomers acrylic acid and

cross-linker. When manufacturing superabsorbent polyacrylate from sodium acrylate,

tetra(allyletoxy)ethane and 1,1,1 trimethylolpropane triacrylate (TMPTA) are normally used

for cross-linking. Other monomers which can benefit the cross-linking of polyacrylate are

glycerol propoxytriacrylate, triallylamine, divinyl toluene, polyethylene glycol monoallyl

ether, ethylene glycol diglycidyl or polyglycidyl ether. Manufacturers of superabsorbent

polyacrylate keep recipes secret, so it can be difficult to identify the substances. The

threshold value for the content of classified residual monomers is 1,000 ppm.

Nonwoven: Nordic Ecolabelling has tested wet wipes made of nonwoven and has found that

allergenic chemicals such as methylisothiazolinone (MI), methylchloroisothiazolinone (CMI)

and glutaraldehyde may have been used in process water in the manufacturing process. If

these substances have been used in manufacturing, it must be ensured that contents of these

substances in the final product do not exceed 0.10 ppm (µ g/g). IVL’s assessment is that this

may also be relevant for other feminine hygiene products which contain nonwoven material

(sanitary towels).

Odorants: Odour-neutralizing technology

The Finnish Safety and Chemicals Agency (Tukes) received more than 20 reports about

Always sanitary towels with “odour-neutralizing technology”22 during the summer and

autumn. The term “odour-neutralizing” was considered misleading as the additive of

odorants did not neutralize odours but rather masked them. The scents were not presented

to the consumers.

1

In the literature study, no information on the component substances for odour reduction or

scenting was identified.

3 Identification of potentially relevant substances in the product group PC 39 Cosmetics and Personal Care Products

Potentially relevant substances in feminine hygiene products have been identified both on a

group level and on a substance level by producing a cross-section of the substances

registered in the market sector PC 39: Cosmetics, personal care products in Annex XV of

REACH and substances with a harmonised classification as CMR or allergenic/sensitising in

accordance with CLP, classed as PBT substances and endocrine disruptors identified in

IPCP’s (International Panel on Chemical Pollution) report on endocrine disruptors23.

Substances used as biocides have also been included, and the substances included in the

Candidate List. The identified substances have been compiled in Appendix 3 together with

CAS number, hazard classification and source reference. There are 132 substances in the

list. It should be noted that this list is composed of substances which are found in a broader

product group than simply feminine hygiene products as the premise is substances which

are registered in accordance with REACH in market sector PC 39, which encompasses

cosmetics, personal care products

The list is based on:

Excerpt from category “PC39: Cosmetics, personal care products” from REACH24.

Substances classified as CMR (Carc 1A, 1B, 2, Muta 1A, 1B, 2, Repr 1A, 1B, 2) and

allergenic/sensitising (Resp. sens 1, Skin sens. 1) were taken from CLP, only harmonised classifications25.

PBT substances26.

Endocrine disrupting substances were identified in IPCP’s report on endocrine disruptive

substances23.

Biocides were taken from the Biocidal Products Regulation and both approved substances and those under evaluation were included27.

Substances on the Candidate List of SVHC, which are subject to permit requirements28.

4 Screening Qualitative chemical analysis of 35 articles samples has been carried out at IVL’s laboratory

in Stockholm. Material samples for the screening have been selected by the Swedish

Chemicals Agency. The following table contains a list of the material samples and general

information on the material included based on information on the packaging.

20

Table 8 Product samples, sanitary towels and panty liners, to Screening

IVL no.

Type

Brand

Information re: material on packaging

Topside/surface layer

Absorbent material

Other

MR6496 Sanitary towel -1

Libresse polyolefin, pulp, polyolefin film

polyolefin pulp polyolefin film


TENA extra (blue packaging)


ICA Basic Norm l (thicker towel)

MR6499

Sanitary towel -4

Apotek hjärtats bindor med vingar Maxi

Absorbent material: cellulose (totally chlorine free TCF). Surface layer (nonwoven): polypropylene. Impermeable barrier layer: polyethylene. Adhesive and silicone paper. Contains no optical brighteners or perfume.

(nonwoven): polypropylene

cellulose (TCF)

Impermeable barrier layer: polyethylene. Adhesive and silicone paper. Contains no optical brighteners or perfume.


Always ultra night

MR6501

Sanitary towel -6

Siempre Ultra normal w/ Aloe Vera

Aloe vera

MR6502

Sanitary towel -7

Towel Naturesoft Super Day (green packaging)

cotton

cotton

MR6503

Panty liner-1

Libresse Daily Fresh

Polyolefin, Pulp, Polyolefin film. Polyethylene glycol, perfume, benzyl alcohol, limonene. Contains lactic acid

polyolefin

pulp

polyolefin film. Polyethylene glycol, perfume, Benzyl alcohol, limonene, lactic acid

MR6504

Panty liner-2

Natracare curved (organic)

organic cotton, cellulose pulp, corn starch

cotton, organic cellulose pulp, corn starch

MR6505

Panty liner-3

Always Large Extra Protect (100 % odour protection)

MR6506

Panty liner-4

Always Normal Fresh & Protect Fresh scent

MR6507 Panty liner-5

TENA Mini Magic (pink packaging)


ICA’s brand

MR6509

Panty liner-7

Apoliva Normalt trosskydd

Non-woven, polyethylene, cellulose, silicone paper, rubber-based hot-melt adhesive.

Non-woven

Cellulose

silicone paper, rubber-based hot-melt adhesive

MR6510

Panty liner-8

Coop XTRA Normal

Topside: Nonwoven (unwoven fabric). Absorbent layer: Bleached cellulose pulp. Underside/barrier layer: Polyethylene.

Non-woven

cellulose pulp, bleached

Impermeable barrier layer: polyethylene

MR6511

Panty liner-9

Änglamark Normal

Topside: Organic cotton. Absorbent layer: Cellulose pulp, chlorine-free bleaching. Underside/barrier layer: Breathable, biodegradable film, made from renewable materials

cotton, organic

Cellulose pulp, chlorine-free bleaching

Underside/barrier layer: Breathable, biodegradable film, made from renewable materials


Caroli

21

Figure 5: Product samples: sanitary towels and

panty liners.

Table 9: Product samples, tampons, for screening

IVL no. Type Brand Information on material on the packaging

Topside/ surface layer

Absorbent material

Other

MR6513 Tampon -1 Tampax Super

MR6514 Tampon -2 ICA Basic Norm l

MR6515

Tampon -3 ICA Normal Miljömärkt Svanen

Core: viscose. Surface layer: non-woven. String: Cotton and polyester.

Non-woven

viscose String: Cotton and polyester.

MR6516 Tampon -4 O.B. ProComfort Night

MR6517 Tampon -5 Natracare cotton tampons organic cotton

Cotton, unscented, chlorine-free bleaching.

Cotton, not chlorine-free bleaching.

unscented

MR6518

Tampon -6 Lingonvecka (Renée Voltaire) 100 % organic cotton

Organic cotton, chlorine-free bleaching, unscented. pH neutral.

Cotton, organic, chlorine-free bleaching.

unscented. pH neutral.

MR6519 Tampon -7 Libresse Super

MR6520

Tampon -8

Coop Super Plus Surface layer: Nonwoven PES/PE fabric. Core 100% viscose. String 100% cotton.

non-woven, polyethylene/ polyester

viscose, 100%

String: Cotton, 100%

MR6521

Tampon -9

Intuition

Core: viscose. Surface layer: nonwoven polyethylene/polyester. String: Cotton and polyester.

nonwoven polyethylene/polyester

viscose

String: Cotton and polyester.

MR6522 Tampon -10

Sence

22

Figure 6: Product samples: tampons.

Table 10: Product samples, menstrual cups, for screening

IVL no. Type Brand Information on material on the packaging

Topside/ surface layer

Absorbent material

Other

MR6523 Cup-1 Organicup Medical grade silicone Silicone

MR6524 Cup-2 Lunette Medical grade silicone. Latex-free, BPA-free.

Silicone

MR6525

Cup-3

MeLuna Menskopp Thermoplastic elastomer approved for medical use.


MR6526

Cup-4

Svenska Menskoppen

Thermoplastic elastomer Thermoplastic elastomer

MR6527 Cup-5 MoonCup Medical grade silicone Silicone

MR6528 Cup-6 Monthly Cup Silicone Silicone

MR6529 Cup-7 Menskopp Wcup av silikon Silicone Silicone

MR6530 Cup-8 The DivaCup Silicone. No latex, rubber, plastic or BPA

Silicone

Figure 7: Product samples: menstrual cups.

23

4.1 Method For each product, a methanol or methanol/water extraction was performed as below. The

following was used for the extraction: methanol (Rathburn), water (MilliQ Academic,

Millipore), glass tubes 50 ml volume (which were decontaminated by sealing with

aluminium foil and heating to 400°C for at least 4h, screw caps with teflon lining rinsed

with methanol, scissors rinsed with methanol, ultrasonic bath, nitrile gloves.

For sanitary towels and panty liners, samples were taken from the middle of the packaging, the cover

was removed and three strips measuring around 1 cm each were taken across the product’s mid-point.

The strips (weighing a total 0.5–1 g) were transferred to the glass tube and methanol was

added. For sanitary towels, 30 ml was used, and for panty liners 15 ml.

For tampons, the outer packaging was removed (in one case, sample 6513, the outer sleeve

was also removed) and a sample measuring approx. 1 cm was cut from the rounded end. The

weight was 0.5 to 1 g. A total 15 ml of equal parts methanol and water was added.

For menstrual cups, a piece measuring approx. 30 × 25 mm was cut out (weight 1.5 to 3 g;

15–20% of the entire sample weight). The piece was then cut down to approx. 1 × 1 mm and

transferred to glass tubes. 10 ml of methanol was added.

For all analysis series, blank samples consisting of solvent without added samples were

also prepared. All tubes were placed in an ultrasonic bath for 20 min and then centrifuged.

The extract was analysed with a Dionex Ultimate 3000 (Thermo Scientific) UPLC system

linked to a Q Exactive Focus (Thermo Scientific) Orbitrap HRMS. Column: Accucore C18 50

x 2.1 mm, particle size 2.6 µm (Thermo Scientific). The column was subjected to gradient

elution, from 5 to 95 per cent methanol in 10 mM acetic acid in water, column temperature

35°C. The mass spectrometer was scanned from 75 to 1000 m/z at the instrument’s highest

resolution (70,000). A channel for AIF (all ion fragmentation) in the same mass range with a

resolution of 17,500 and collision energy of 30 eV was run in parallel. Separate runs were

made with positive and negative ionisation. For data collection, the software Xcalibur

(Thermo Scientific) was used.

Interpretation of data was performed using the software TraceFinder 3.3 (Thermo Scientific)

as a combination of “suspect screening” and “non-target screening”. In both cases, the first

step is “deconvolution”; a process whereby the software identifies the mass number that forms

peaks in the chromatogram. The mass number is expressed as an integer with four decimals.

In “suspect screening”, the mass numbers are compared with a database of theoretical mass

numbers for substances where the aim is to determine either that they probably are or

probably are not present in the sample. In “non-target screening”, the aim is to find a potential

sum formula based on the found mass numbers and to use this to find a chemical identity.

Here too, subject databases can be of use. In both cases, consideration is given to the fact that

the substances often form adducts; in positive ionization M+H, M+Na, M+NH4, etc., and in

negative ionization, primarily M-H. If several adducts for a certain mass are produced at the

same retention times, this substantiates the identification. As a permitted difference between

theoretical and identified mass, 5 ppm is used; i.e., if the mass is 200, the permitted deviation

is 0.001 mass units. A certain sum formula, apart from giving a mass number, also provides

an isotope pattern and sometimes typical fragmentations. Both of these properties can

substantiate the identification.

Use databases on what can be termed as risk substances, comprising (number of substances in

parentheses) perfluorinated compounds (129), biocides and medicines (1,729), substances

which should not be present in textile in accordance with OekoTex_Standard_10029 (61),

aromatic amines as per REACH 17 App. 8 (22). More general databases comprises substances

which can be considered problematic in textiles (976), components in tensides (410), and two

databases with substances from the product register (6,330 and 24,846).

24

The reported peaks were found in the regular samples in significantly higher concentrations

than in the blank samples. Hits in the databases with risk substances have been prioritised.

We have refrained from reporting hits that do not have a high likelihood of being correct. The

degree of certainty when identifying impurities using high-resolution mass spectrometry can

be specified using a scale proposed by Schymanski et al.30. The scale is from 1 to 5, where 1

is the most certain. In the results column “Conf”, a value based on this scale is given. A

degree of 1 means that a standard of the substance in question has been analysed and that the

mass spectrum and retention time correspond to those of the unknown sample.

The adopted method has great potential to separate and detect a broad spectrum of organic

compounds of a polar nature, such as most biocides, colourants and medicine. Exceptions are

non-polar substances of the type PCB and PBDE, volatile substances and substances with a

low molecular weight, and very unstable molecules such as glyphosate which, however, can

be analysed after derivatisation. Table 15 contains comments on the possibility to identify in

the screening substances which were found in the literature study.

The extract from the sample Sanitary Towels 1-7 (6496-6502 and associated blanks) has, in

collaboration with Stellan Fisher, KEMI, been evaluated against a substance database which

also includes the indices “exposure score” and “hazard score”. A higher exposure score

means that the substance is more commonly found in society; a higher hazard score means

that the substance is deemed to entail higher risks. A hazard score of “-” means that the

information is missing. Development of these indices is under way. Information can be found

at: http://www.norman-network.com/?q=node/236.

4.2 Results

Tables 11-14 below present the results of the screening in the form of identified substances.

In each row of the tables, the sample where the highest signal intensity was attained is

denoted by the figure 1. Other figures show relative signal intensity within the same row.

The colour intensity is proportional to the figure value. Substances identified during the

screening are reported with more data in appendix 4 table 4.1.

In appendix 4, a separate table (4.2) presents the substances identified in the evaluation

performed in collaboration with KemI, where the extract was evaluated against a substance

database which also included the indices “exposure score” and “hazard score”.

Table 11 Sanitary towels.

6496

Sanitary towel 1

6497

Sanitary towel 2

6498

Sanitary towel 3

6499

Sanitary towel 4

6500

Sanitary towel 5

6501

Sanitary towel 6

6502

Sanitary towel 7

Conf.

Nonylphenol

ethoxylate

NPEO3-NPEO8

1

1

Abietic acid 0.04

0.05

0.01

0.01

1

1

Alcohol ethoxylate

C10AEO3 - C10AEO7

0.02

0.35

1

2

Polyethylene

gylcol

PEG EO5-EO9

0.17

0.68

0.18

0.09

1

2

25

Table 12 Panty liners.

6503 Panty liner 1

6504 Panty liner 2

6505 Panty liner 3

6506 Panty liner 4

6507 Panty liner 5

6508 Panty liner 6

6509 Panty liner 7

6510 Panty liner 8

6511 Panty liner 9

6512 Panty

liner 10

Conf.

Polyethylene glycol PEG EO9

1

0.003

0.002

0.001

0.005

0.003

0.002

0.021

2

Methyl dihydrojasmonate, 37172-53-5, odorant

1

0.78

0.90

3

Table 13 Tampons.

6513 Tampon 1

6514 Tampon 2

6515 Tampon 3

6516 Tampon 4

6517 Tampon 5

6518 Tampon 6

6519 Tampon 7

6520 Tampon 8

6521 Tampon 9

6522 Tampon

10

Conf.

Polyethelene glycol PEG EO5-EO13

0.06 0.11 0.11 1 0.002 0.002 0.15 0.13 0.10 0.12 2

Table 14 Menstrual cups.

6523 Cup 1

6524 Cup 2

6525 Cup 3

6526 Cup 4

6527 Cup 5

6528 Cup 6

6529 Cup 7

6530 Cup 8

Conf.

D4, Octamethylcyclotetrasiloxane, 556-67-2

0.03 0.04 0.05 0.04 1 0.05 1

D5, Decamethylcyclopentasiloxane, 541-02-6

0.02 0.005 0.02 0.02 1 0.01 1

D6, Dodecamethylcyclohexasiloxane, 540-97-6

0.02 0.00 0.004 0.01 1 0.005 1

D7, Tetradecamethylcycloheptasiloxane, 107-50-6

1 0.52 0.15 0.54 0.40 2

D8, Hexadecamethylcyclooctasiloxane, 556-68-3

0.74 1 0.09 0.37 0.22 2

D9, Octadecamethylcyclononasiloxane, 556-71-8

0.20 0.38 0.03 0.09 1 0.07 2

Benzophenone, 119-61-9 0.00 0.00 0.00 0.00 0.00 1 1

Propylbenzoic acid, 2438-05-3

0.01 1 0.01 0.02 0.003 0.06 4

5 Conclusions and discussion In this work, the potential presence of hazardous substance in feminine hygiene products has

been identified through literature studies, searches in databases and the screening analysis of

obtained material samples. A shorter list of substances found on two or all three lists is

presented in Appendix 5.

A list of substances proposed for quantitative analysis has been produced. Substances with the

following criteria have been included in this list.

1. Substances identified with chemical analysis that were presented in the

literature study and which were classified as CMR (Carc 1A, 1B, 2, Muta 1A,

1B, 2, Repr 1A, 1B, 2) and allergenic/sensitising (Resp. sens 1, Skin sens 1)

(Appendix 1)

26

2. Substances identified during the screening and classified as CMR (Carc 1A, 1B, 2,

Muta 1A, 1B, 2, Repr 1A, 1B, 2) and allergenic/sensitising (Resp. sens 1, Skin sens.

1) (Appendix 4)

3. Substances identified during searches in databases and which were also

mentioned in the literature study (Appendix 5)

4. Substances mentioned in the Nordic environmental labelling (see section 2)

5. Other substances where there may be concerns over their presence, based on literature studies

Substances recommended for quantitative analysis are presented in table 15 below. More

information on the substances is presented in appendix 6.

Some comments on the study carried out

Literature in the form of academic publications, reports and online news articles

showed that there is very limited information available about chemical substances in

feminine hygiene products. The majority of documents refer back to a small number

of published studies.

Published work that has been identified has mainly been carried out in order to

quantify substances that are suspected to be present, which are deemed to be

hazardous in other contexts and where a proven chemical analysis procedure was

available. The recorded concentrations are mostly low.

With a few exceptions (Benzophenone, D4 and D5), the substances identified in the

screening study have not been reported in the literature study. The cause of this may

partly be what is presented above – that in reported studies, we have primarily looked

for substances deemed hazardous in other contexts. Other causes may be that the

substances or substance groups not identified can be identified with the method used

for screening; these may for example include dioxines, metals or substances with a

low molecular weight. A number of such reasons have been provided in the table with

proposed substances for quantitative analysis; table 15.

It should be noted that the list produced based on the substances registered in market

sector PC 39: Cosmetics, personal care products in Annex XV of REACH (see

Appendix 2, table 2:2) consist of substances found in a broader product group than

feminine hygiene products.

The adopted method has great potential to separate and detect a broad spectrum of

organic compounds of a somewhat polar nature, such as most biocides, colourants and

medicine. Exceptions are non-polar substances of the type PCB and PBDE, volatile

substances and substances with a low molecular weight, and very unstable molecules

such as glyphosate.

As no information on the identity of perfume or odorants could be found in the

literature overview, we propose an analysis of relevant products with a headspace

GC/MS.

27

Table 15 List of proposed substances for quantitative analysis

Substance Reason for inclusion in the list Other reason for

inclusion in the list

Source of

suspected

presence

Product type

Selection

Literature

Screening

Screening remark

Formaldehyde is mentioned in Nordic

ecolabelling criteria

cross-section between lists

residues in dried adhesive

all x x

L

Glutaraldehyde is mentioned in Nordic ecolabelling criteria


disinfection all x x

Butyl methacrylate is mentioned in the literature cross-section between lists

superabsorbents all x x

Isopropyl alcohol has been established in the study on Always sanitary towels


disinfection? Solvent residues?

all

x

x

L

Vinyl acetate has been established in the study on Always sanitary towels


polyvinyl acetate all x x

Triclosan is mentioned in Nordic ecolabelling criteria


anti-bacterial all x x

cross-section between

Benzophenone screening menstrual cups lists and menstrual cups x x

screening

Octamethylcyclotetrasiloxane is mentioned in Nordic ecolabelling criteria

cross-section between lists and screening

silicone

menstrual cups

x

x

x

Decamethlcyclopentasiloxane is mentioned in Nordic ecolabelling criteria

cross-section between lists and screening

silicone

menstrual cups

x

x

Nonylphenol ethoxylate Screening sanitary towels x

Abietic acid Screening sanitary towels

1,2,3,7,8-PentaCDD is mentioned in the literature as a potent dioxin

to ease concerns bleaching cotton tampons sanitary towels

x

G

OctaCDD measurable concentrations in the literature study


x G

2,3,7,8-TetraCDD is mentioned in the literature as a potent dioxin


x G

28

Substance Reason for inclusion in the list Other reason for

inclusion in the list

Source of suspected presence

Product type

Selection

Literature

Screening

Screening remark

Glyphosate measurable concentrations in the literature study, consumer concerns

to ease concerns Pesticides Tampons, Sanitary

towels

x

D

Aminomethylphosphonic acid (AMPA)

measurable concentrations in the literature study, consumer concerns

to ease concerns Pesticides tampons, sanitary

towels

x

D

PAH 16 substances measurable concentrations in the literature study

primarily sanitary towels

x

Malaoxon/Malathion measurable concentrations in the literature study

Pesticides tampons

x

Dichlofluanid measurable concentrations in the literature study

Pesticides tampons

x

Mecarbam measurable concentrations in the literature study

Pesticides tampons

x

Procymidone measurable concentrations in the literature study

Pesticides tampons

x

Methidathion measurable concentrations in the literature study

Pesticides tampons

x

Fensulfothion measurable concentrations in the literature study

Pesticides tampons

x

Piperonyl Butoxide measurable concentrations in the literature study

Pesticides tampons

x

Organotin compounds

mentioned in Nordic ecolabelling

residues from production

all apart from menstrual cups

Arsenic and its compounds




M

diisobutyl phthalate mentioned in Nordic ecolabelling



B

2,2-dichloro-4,4-methylenedianiline




2

Substance Reason for inclusion in the list

Other reason for inclusion in the list


Product type

Selection

Literature

Screening

Screening remark

Styrene mentioned in Nordic ecolabelling



Antimony trioxide mentioned in Nordic ecolabelling



M

Adipic acid

Caprolactam

Dimethylformamide







all apart from menstrual cups all apart from menstrual cups all apart from menstrual cups

Dimethylacetamide mentioned in Nordic ecolabelling



Acrylamide is mentioned in Nordic ecolabelling


sanitary towels,

L

Methylisothiazolinone is mentioned in Nordic ecolabelling


sanitary towels

Methylchloroisothiazolinone is mentioned in Nordic

ecolabelling


sanitary towels

Remarks on the screening method:

B: proven, but not in a higher concentration than in the blank

samples

D: requires derivatisation

G: very low concentrations, requires special method

L: molecular weight too low for detection

M: requires analysis method for metallic substances

30

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cancer-stick/

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gauze-contaminated-with-probable-carcinogen-glyphosate/

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https://www.edana.org/discover-nonwovens/products-applications/absorbent-hygiene-products

https://www.libresse.se/allt-om-oss/ingredienser

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http://goo.gl/BgIwdu

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https://drjengunter.wordpress.com/2015/10/24/no-your-tampon-still-isnt-a-gmo-impregnated-toxin-filled

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http://www.womensvoices.org/feminine-care-products/detox-the-box/always-pads-testing-results

https://www.radron.se/tester/mat-halsa--skonhet/tamponger

31

21 http://docplayer.net/42753946-About-nordic-ecolabelled-sanitary-products.html

22 TUKES Finska Kemikalieinspektionen. http://verkkolehti.tukes.fi/produkten-luktar-av-kemikalier-farligt-eller-

inte/

23 The International Panel on Chemical Pollution (IPCP), 2016. Overview Report I: A Compilation of Lists of

Chemicals Recognised as Endocrine Disrupting Chemicals (EDCs) or Suggested as Potential EDCs

24 https://echa.europa.eu/sv/information-on-chemicals/registered-substances. 2017-06-30.

25 https://echa.europa.eu/sv/information-on-chemicals/cl-inventory-database, 2017-08-30.

26 https://www.echa.europa.eu/web/guest/advanced-search-for-

chemicals?p_p_id=dissadvancedsearch_WAR_disssearchportlet&p_p_lifecycle=0&_dissadvancedsearch_

WAR

_disssearchportlet_searchOccurred=true&_dissadvancedsearch_WAR_disssearchportlet_sessionCriteriaId=

diss AdvancedSearchSessionParam101401504609897486, 2017-09-04

27 https://echa.europa.eu/sv/information-on-chemicals/biocidal-active-

substances?p_auth=Cixyz81p&p_p_id=echarevbiocides_WAR_echarevbiocidesportlet&p_p_lifecycle=1&p_p_

s tate=normal&p_p_mode=view&p_p_col_id=column-

1&p_p_col_pos=1&p_p_col_count=2&_echarevbiocides_WAR_echarevbiocidesportlet_viewTab=Search&_ech

arevbiocides_WAR_echarevbiocidesportlet_javax.portlet.action=tabsAction&_echarevbiocides_WAR_echarevb

iocidesportlet_tabs1=Summary. 30/06/2017

28 https://echa.europa.eu/sv/candidate-list-table, 2017-08-30

29

https://www.oeko-tex.com/se/business/certifications_and_services/ots_100/ots_100_start.xhtml

30

Emma L. Schymanski, Junho Jeon, Rebekka Gulde, Kathrin Fenner, Matthias Ruff, Heinz P. Singer, and

Juliane Hollender Identifying Small Molecules via High Resolution Mass Spectrometry: Communicating

Confidence Environ. Sci. Technol., 2014, 48 (4), pp 2097–2098, DOI: 10.1021/es5002105

http://docplayer.net/42753946-About-nordic-ecolabelled-sanitary-products.html

http://verkkolehti.tukes.fi/produkten-luktar-av-kemikalier-farligt-eller

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https://www.echa.europa.eu/web/guest/advanced-search-for

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https://echa.europa.eu/sv/candidate-list-table

https://www.oeko-tex.com/se/business/certifications_and_services/ots_100/ots_100_start.xhtml

Appendix 1

Substances which may be present in feminine hygiene products based on the examined literature

Substances in the list have been mentioned in the reviewed data. Substances marked in yellow have been detected in the reported analyses. Where available,

harmonised and notified classifications (where there are deviations from the harmonised classification) have also been specified for the criteria (Carc 1A, 1B, 2, Muta

1A, 1B, 2, Repr ,1A, 1B, 2) and allergenic/sensitising (Resp. sens 1, Skin sens 1). Data obtained from https://echa.europa.eu/sv. Rows marked in yellow present the

substances which according to the literature data were found during chemical analysis and which also fulfil these criteria.

Substance

Trivial name /Abbreviation

CAS number

EC number

Harmonised classification

Notified classification

2,3,7,8-TetraCDD CDD = chlorodibenzo-p-dioxin

1746-01-6

217-122-7

1,2,3,7,8-PentaCDD 40321-76-4

1,2,3,4,7,8-HexaCDD 39227-28-6

1,2,3,6,7,8-HexaCDD 57653-85-7

1,2,3,7,8,9-HexaCDD 19408-74-3

1,2,3,4,6,7,8-HeptaCDD 35822-46-9 muta2

OctaCDD 3268-87-9

2,3,7,8-TetraCDF 51207-31-9

1,2,3,7,8-PentaCDF 57117-41-6 muta2

2,3,4,7,8-PentaCDF 57117-31-4 694-761-1 carc1a

IVL Svenska Miljöinstitutet AB

IVL Swedish Environmental Research Institute Ltd.

C.I.N.: 556116-2446

VAT no.: SE556116244601

Box 21060, SE-100 31 Stockholm

Valhallavägen 81, 114 27 Stockholm

Box 53021, SE-400 14 Göteborg

Aschebergsgatan 44, 411 33 Göteborg

Registered office: Stockholm Tel: +46 (0)10-788 65 00 Tel: +46 (0)10-788 65 00

www.ivl.se Fax: +46(0)10-788 65 90 Fax: + 46 (0)10-788 68 90

http://www.ivl.se/

Substance


CAS number

EC number



1,2,3,4,7,8-HexaCDF 70648-26-9

1,2,3,6,7,8-HexaCDF 57117-44-9

1,2,3,7,8,9-HexaCDF 72918-21-9 muta2

2,3,4,6,7,8-HexaCDF 60851-34-5

1,2,3,4,6,7,8-HeptaCDF 67562-39-4

1,2,3,4,7,8,9-HeptaCDF 55673-89-7

OctaCDF

CDF = chlorodibenzofuran

39001-02-0

Naphthalene 91-20-3 202-049-5 Carc2

Acenaphthylene 208-96-8 205-917-1

Acenaphthene 83-32-9 201-469-6

Fluorene 86-73-7 201-695-5

Phenanthrene 85-01-8 201-581-5 skin sens1

Anthracene 120-12-7 204-371-1 skin sens2

Fluoranthene 206-44-0 205-912-4

Pyrene 129-00-0 204-927-3

Benzo(a)anthracene 56-55-3 200-280-6 Carc1b

Chrysene 218-01-9 205-923-4 Carc1b, Muta2

Benzo(b)fluoranthene 205-99-2 205-911-9 Carc 1b

Benzo(j)fluoranthene 205-82-3 205-910-3 Carc 1b

Benzo(k)fluoranthene 207-08-9 205-916-6 Carc 1b

Benzo(a)pyrene

50-32-8

200-028-5

SkinSens1, Muta1b, Carc1b, Repr1b

Dibenzo(a,h)anthracene 53-70-3 200-181-8 Carc1b

Indeno(1,2,3-cd)pyrene 193-39-5 205-893-2 n.a. Carc 2 Benzo(ghi)perylene 191-24-2 205-883-8 n.a.

Diisobutyl phthalate DiBP 84-69-5 201-553-2 Repr1b

Di-n-butyl phthalate DnBP 84-74-2 201-557-4 Repr1b

Butylbenzyl phthalate BBzP 85-68-7 201-622-7 Repr1b

Bis(2-ethylhexyl) phthalate DEHP 117-81-7 204-211-0 Repr1b

Substance


CAS number

EC number



Bis(2-methoxyethyl) phthalate DMEP 117-82-8 204-212-6 Repr1b

Diisopentyl phthalate DiPP 605-50-5 210-088-4 Repr1b skinsens1

Di-n-pentyl phthalate DnPP 131-18-0 205-017-9 Repr1b

Di-n-hexyl phthalate DnHP 84-75-3 201-559-5 Repr1b

Glufosinate sesquisodium salt 51276-47-2

Glyphosate 70393-85-0

Aminomethylphosphonic acid (AMPA)

1066-51-9

623-325-5 n.a

Aldrin 309-00-2 206-215-8 Carc2

Atrazine 1912-24-9 217-617-8 Skinsens1

Camfechlor (Toxaphene) 8001-35-2 232-283-3 Carc2

Cyfluthrin 68359-37-5 269-855-7

2,4-D 94-75-7 202-361-1 Skinsens1

DDT 50-29-3 200-024-3 Carc2

Diazinon 333-41-5 206-373-8

Dichlorvos (Lindane) 62-73-7 200-547-7 Skinsens1

Dieldrin 60-57-1 200-484-5 Carc2

Dicofol 115-32-2 204-082-0 Skinsens1

Endosulfan 115-29-7 204-079-4

Endrin 72-20-8 200-775-7

Fluazifop butyl 69806-50-4 274-125-6 Repr1b

Fenvalerate 51630-58-1 257-326-3

Heptachlor epoxide Heptachloropoxide 1024-57-3 213-831-0 Carc2

Hexachlorobenzene 118-74-1 204-273-9 Carc1b

Captan 133-06-2 205-087-0 Skinsens1 Carc2

Carbaryl 63-25-2 200-555-0 Carc2

Quintozene 82-68-8 201-435-0 Skinsens1

Lambdacyhalothrin 91465-08-6 415-130-7

Methoxychlor 72-43-5 200-779-9 Carc2, repr2

Substance


CAS number

EC number



Pentachlorophenol 87-86-5 201-778-6 Carc2

Permethrin 52645-53-1 258-067-9 Skinsens1

Pirimicarb 23103-98-2 245-430-1 Skinsens1 Carc2

Simazine 122-34-9 204-535-2 Carc2

2,4,5-T 93-76-5 202-273-3

Trifluralin 1582-09-8 216-428-8 Skinsens1 Carc2

Malaoxon/Malathion 1634-78-2

Dichlofluanid 1085-98-9 214-118-7 Skinsens1

Mecarbam 2595-54-2 219-993-9

Procymidone 32809-16-8 Repr1b

Methidathion 950-37-8 213-449-4 skinsens1

Fensulfothion 115-90-2 204-114-3

Pyrethrum plant

Piperonyl Butoxide 06/03/1951 200-076-7 Repr2

Methyl acrylate 96-33-3 202-500-6 skinsens1

Ethyl acrylate 140-88-5 205-438-8 skinsens1

Butyl acrylate 141-32-2 205-480-7 skinsens1

Butyl methacrylate 97-88-1 202-615-1 skinsens1

tert-Butyl acrylate 1663-39-4 216-768-7 skinsens1

Ethylene diacrylate 2274-11-5 218-886-4 skinsens1

2-Ethylhexyl methacrylate 688-84-6 211-708-6

Hydroxypropyl acrylate 999-61-1 213-663-8 skinsens1

1,6-hexanediol diacrylate 13048-33-4 13048-33-4 skinsens1

Ethylenglycol diacrylate 2274-11-5 218-886-4 skinsens1

Glycerol tricaprylate 538-23-8 208-686-5

Oleyl Alcohol 143-28-2 205-597-3

Formaldehyde 50-00-0 200-001-8 skinsens1 carc1b

1,2,4-Trimethylbenzene 95-63-6 202-436-9

Substance


CAS number

EC number



1,3,5-Trimethylbenzene 526-73-8 208-394-8

2-Butanone 78-93-3 201-159-0

4-Ethyltoluene 622-96-8 210-761-2

Acetone 67-64-1 200-662-2

Chloroethane 75-00-3 200-830-5 carc2

Chloroform 67-66-3 200-663-8 carc2, repr2

Chloromethane 74-87-3 200-817-4 carc2

Cyclohexane 110-82-7 203-806-2

Ethyl acetate 141-78-6 205-500-4 skinsens1

Ethylbenzene 100-41-4 202-849-4

Heptane 142-82-5 205-563-8

Isopropyl alcohol 67-63-0 200-661-7

m-Xylene 108-38-3 203-576-3

p-Xylene 106-42-3 203-396-5

o-Xylene 95-47-6 202-422-2

Styrene 100-42-5 202-851-5 repr2

Toluene 108-88-3 203-625-9 repr2

trans-1,2-Dichloroethene 156-60-5 205-860-2

Vinyl acetate 108-05-4 203-545-4 carc2

Methylchloroisothiazolinone 26172-55-4 247-500-7 skinsens1

Methylisothiazolinone 2682-20-4 220-239-6 skinsens1

Glutaraldehyde 111-30-8 203-856-5 skinsens 1a respsens 1

Quaternium-15 4080-31-3 223-805-0

Quaternium-15 cis form 51229-78-8 426-020-3 skinsens1 repr2

DMDM Hydantoin 6440-58-0 229-222-8 skinsens1

D&C Red No.33 3567-66-6 222-656-9

Ext D&C Violet#2 4430-18-6 224-618-7

FD&C Yellow #5 1934-21-0 217-699-5

Octamethylcyclotetrasiloxane 556-67-2 209-136-7 repr2

Substance


CAS number

EC number



Decamethylcyclopentasiloxane 541-02-6 208-764-9

Abietic acid 514-10-3 208-178-3 skinsens1

10,10’-oxybisphenoxarsine 58-36-6 200-377-3 carc1a

Triclosan 3380-34-5 222-182-2

2,2'-dichloro-4,4'-methylenedianiline 101-14-4 202-918-9 carc1b

Antimony trioxide 1309-64-4 215-175-0 carc2

caprolactam 105-60-2 203-313-2

Adipic acid 124-04-9 204-673-3

Dimethylacetamide 127-19-5 204-826-4 repr1b

Dimethylformamide 68-12-2 200-679-5 repr1b

Acrylamide 79-06-1 201-173-7 skinsens1 muta1b carc1b repr2

Tetraallylethoxy ethane 29895-12-3

1,1,1 Trimethylolpropanetricrylate 3454-29-3 222-384-0 skin sens 1 resp sens 1

Nitric acid 7697-37-2 231-714-2

Appendix 2

Chemicals from Swiss study: Substances chimiques présentes dans les protections hygiéniques: Evaluation des risques. Département fédéral de l'intérieur DFI,

Office fédéral de la sécurité alimentaire et des affaires vétérinaires OSAV, Evaluation des risques, Confédération suisse.


Table 2:1. Dioxins in tampons. Concentrations in pg/g; total PCDD/F in pg/g of toxic equivalents (pg/g TEQ). Dioxins 16-01963 16-01965 16-01967 16-01968 16-01973 16-01978 16-01998 16-02001

2,3,7,8-TetraCDD <0.011 <0.013 <0.012 <0.012 <0.012 <0.013 <0.013 <0.013

1,2,3,7,8-PentaCDD <0.015 <0.017 <0.016 <0.016 <0.016 <0.017 <0.017 <0.017

1,2,3,4,7,8-HexaCDD <0.023 <0.025 <0.024 <0.025 0.0293 <0.026 <0.026 0.0297

1,2,3,6,7,8-HexaCDD <0.031 <0.034 <0.033 <0.034 <0.033 <0.035 <0.035 <0.036

1,2,3,7,8,9-HexaCDD <0.029 <0.032 <0.031 <0.032 <0.031 <0.033 <0.033 <0.034

1,2,3,4,6,7,8-HeptaCDD 0.333 <0.053 <0.050 0.233 0.49 0.231 0.277 0.428

OctaCDD 4.49 <0.38 <0.036 4.87 7.69 4.04 4.73 6.22

2,3,7,8-TetraCDF <0.031 <0.034 <0.033 <0.034 <0.033 <0.035 <0.035 <0.036

1,2,3,7,8-PentaCDF <0.022 <0.024 <0.023 <0.023 <0.023 <0.024 <0.024 <0.025

2,3,4,7,8-PentaCDF <0.034 <0.037 <0.035 <0.036 <0.036 <0.038 <0.038 <0.039

1,2,3,4,7,8-HexaCDF <0.035 <0.039 <0.037 <0.038 <0.038 <0.04 <0.040 <0.041

1,2,3,6,7,8-HexaCDF <0.032 <0.036 <0.034 <0.035 <0.035 <0.036 <0.036 <0.037

1,2,3,7,8,9-HexaCDF <0.024 <0.026 <0.025 <0.026 <0.036 <0.027 <0.027 <0.028

2,3,4,6,7,8-HexaCDF <0.029 <0.032 <0.031 <0.032 <0.031 <0.033 <0.033 <0.034

1,2,3,4,6,7,8-HeptaCDF <0.034 <0.037 <0.035 <0.036 0.0995 <0.038 <0.038 <0.039

1,2,3,4,7,8,9-HeptaCDF <0.023 <0.026 <0.024 <0.025 <0.025 <0.026 <0.026 <0.027

OctaCDF <0.072 <0.079 <0.075 <0.078 0.248 <0.081 <0.081 <0.083

Total PCDD/F TEQ, LQ excl. 0.00468 ND ND 0.00379 0.0112 0.00353 0.00419 0.00912

Total PCDD/F TEQ, LQ incl. 0.0661 0.0683 0.0648 0.0698 0.0738 0.0725 0.0729 0.0771

N.D. not detected



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Table 2:2. Dioxins in sanitary towels. Concentrations in pg/g; total PCDD/F in pg/g of toxic equivalents (pg/g TEQ). Dioxins 16-01964 16-01966 16-01974 16-01975 16-01976 16-01977 16-01997 16-02000

2,3,7,8-TetraCDD <0.012 <0.011 <0.012 <0.012 <0.011 <0.012 <0.013 <0.013

1,2,3,7,8-PentaCDD <0.0246 <0.014 <0.016 <0.015 <0.014 <0.016 <0.016 <0.017

1,2,3,4,7,8-HexaCDD <0.025 <0.022 <0.024 <0.023 <0.021 <0.025 <0.025 <0.025

1,2,3,6,7,8-HexaCDD <0.034 <0.030 <0.033 <0.032 <0.029 <0.034 <0.034 <0.034

1,2,3,7,8,9-HexaCDD <0.032 <0.028 <0.031 <0.030 <0.027 <0.032 <0.032 <0.032

1,2,3,4,6,7,8-HeptaCDD <0.052 <0.046 <0.051 <0.049 <0.045 <0.053 <0.053 <0.053

OctaCDD <0.38 <0.33 <0.37 <0.35 <0.32 <0.38 <0.38 <0.38

2,3,7,8-TetraCDF <0.034 <0.030 <0.033 <0.032 0.0385 <0.034 <0.034 <0.034

1,2,3,7,8-PentaCDF <0.023 <0.021 <0.023 <0.022 <0.020 <0.024 <0.024 <0.024

2,3,4,7,8-PentaCDF <0.037 <0.032 <0.036 <0.034 <0.031 <0.037 <0.037 <0.037

1,2,3,4,7,8-HexaCDF <0.039 <0.034 <0.038 <0.036 <0.033 <0.039 <0.039 <0.039

1,2,3,6,7,8-HexaCDF <0.035 <0.031 <0.035 <0.033 <0.030 <0.035 <0.036 <0.036

1,2,3,7,8,9-HexaCDF <0.026 <0.023 <0.026 <0.024 <0.022 <0.026 <0.026 <0.026

2,3,4,6,7,8-HexaCDF <0.032 <0.028 <0.031 <0.030 <0.027 <0.032 <0.032 <0.032

1,2,3,4,6,7,8-HeptaCDF <0.037 <0.032 <0.036 <0.034 <0.031 <0.037 <0.037 <0.037

1,2,3,4,7,8,9-HeptaCDF <0.025 <0.022 <0.025 <0.024 <0.022 <0.026 <0.026 <0.026

OctaCDF <0.078 <0.069 <0.077 0.158 <0.067 0.127 0.121 <0.079

Total PCDD/F TEQ, LQ excl. ND ND ND 0.0000475 0.00385 0.0000382 0.0000364 ND

Total PCDD/F TEQ, LQ incl. 0.0756 0.0589 0.0659 0.0627 0.0587 0.0678 0.068 0.0683

N.D. not detected

Table 2:3. PAH in tampons. Concentrations in µg/g. Total 8-PAH includes PAH benzo(a)anthracene for benzo(ghi)perylene (extra hazardous PAH: les plus dangereuses) PAH 16-01963 16-01965 16-01967 16-01968 16-01973 16-01978 16-01998 16-02001

Naphthalène 9.89 11.1 11.3 12.4 9.04 8.91 35.5 16.3

Acenaphthylène <0.97 <1.1 <1.0 <0.98 <1.0 <0.98 <0.99 <1.1

Acenaphthène 5.02 8.22 6.54 5.65 5.59 5.38 4.82 10.2

Fluorène 1.82 1.79 1.9 1.52 2.01 <0.98 2.67 2.81

Phénanthrène 11.3 9.76 10 11.3 12.6 6.61 13.5 15.4

Anthracène <0.97 <1.1 <1 <0.98 <1.0 <0.98 <0.99 <1.1

Fluoranthène 1.5 <1.1 <1 1.18 <1.0 <0.98 1.31 <1.1

Pyrène <0.97 <1.1 <1 <0.98 <1.0 <0.98 <0.99 <1.1

Benzo(a)anthracène <0.97 <1.1 <1 <0.98 <1.0 <0.98 <0.99 <1.1

Chrysène <0.97 <1.1 <1 <0.98 <1.0 <0.98 <0.99 <1.1

Benzo(b/j)fluoranthène <0.97 <1.1 <1 <0.98 <1.0 <0.98 <0.99 <1.1

Benzo(k)fluoranthène <0.97 <1.1 <1 <0.98 <1.0 <0.98 <0.99 <1.1

Benzo(a)pyrène <0.97 <1.1 <1 <0.98 <1.0 <0.98 <0.99 <1.1

Dibenzo(a,h)anthracène <0.97 <1.1 <1 <0.98 <1.0 <0.98 <0.99 <1.1

Indeno(1,2,3-cd)pyrène <0.97 <1.1 <1 <0.98 <1.0 <0.98 <0.99 <1.1

Benzo(ghi)pérylène <0.97 <1.1 <1 <0.98 <1.0 <0.98 <0.99 <1.1

Total 8-PAH, LQ excl. ND ND ND ND ND ND ND ND

Total 8-PAH, LQ incl. 7.8 8.8 8 7.8 8 7.8 7.9 7.8

N.D. not detected

Table 2:4. PAH in sanitary towels. Concentrations in µg/g. Total 8-PAH includes PAH benzo(a)anthracene for benzo(ghi)perylene (extra hazardous PAH: les plus

dangereuses) PAH 16-01964 16-01966 16-01974 16-01975 16-01976 16-01977 16-01997 16-02000

Naphthalène 19.7 15.5 18.5 19 16 23.7 17.3 24.5

Acenaphthylène 1.09 <0.86 <1.2 <1.1 <1 <1.1 <1.2 <1.2

Acenaphthène 8.81 12.8 18 15 12.5 18.1 15.4 30.9

Fluorène 3.89 2.71 3.14 3.57 4.34 3 6.4 4.88

Phénanthrène 25 18.6 41.4 31.6 20.8 10.8 27.8 96

Anthracène 1.57 <0.86 4.4 <1.97 <1 <1.1 6.68 <8.00

Fluoranthène 10 6.21 <1.2 16.6 12 99.4 17.9 15.9

Pyrène 261 107 9.02 118 473 2150 123 39.5

Benzo(a)anthracène 1.11 2.63 <1.2 <1.1 3.49 3.01 1.94 <1.94

Chrysène 5.85 1.24 <1.2 2.95 13.8 15.6 2.97 1.42

Benzo(b/j)fluoranthène 3.32 7.51 9.91 6.21 2.39 <6.98 5.55 3.89

Benzo(k)fluoranthène 1.47 1.39 1.72 <2.45 4.43 8.12 1.52 5.64

Benzo(a)pyrène <4.03 2.55 6.25 3.44 <6.65 <13.4 3.03 7.72

Dibenzo(a,h)anthracène <4.46 <0.978 <1.91 <2.16 <6.18 <19.5 <2.55 <7.24

Indeno(1,2,3-cd)pyrène <0.96 <1.22 <6.37 <3.28 <3.06 <4.72 <2.55 <5.85

Benzo(ghi)pérylène <0.96 <1.27 <6.67 <3.44 <3.20 2.56 <2.67 <6.12

Total 8-PAH, LQ excl. 11.75 15.32 17.88 12.6 24.11 29.29 15.01 18.67

Total 8-PAH, LQ incl. 22.1 18.8 34.9 25 43.2 73.9 22.8 39.8

Table 2:5. Formaldehyde, phthalates and pesticides in tampons. Formaldehyde and phthalates in mg/kg(µg/g), pesticides in ng/g. 16-01963 16-01965 16-01967 16-01968 16-01973 16-01978 16-01998 16-02001

Formaldehyde <5 <5 <5 <5 <5 <5 <5 <5

Phtalate de di-isobutyle (DiBP) <1 <1 <1 <1 <1 <1 <1 <1

Phtalate de dibutyle (DBP) <1 <1 <1 <1 <1 <1 <1 <1

Phtalate de benzylbutyle (BBP) <1 <1 <1 <1 <1 <1 <1 <1

Phtalate de bis(2-éthylhexyle) (DEHP) <1 <1 <1 <1 <1 <1 <1 <1

Phtalate de bis(2-methoxyéthyle) (DMEP) <1 <1 <1 <1 <1 <1 <1 <1

Phtalate de di-isopentyle (DPP) <10 <10 <10 <10 <10 <10 <10 <10

Phtalate de di-n-hexyle (DnHP) <1 <1 <1 <1 <1 <1 <1 <1

Phtalate de di-n-pentyle (DnPP) <1 <1 <1 <1 <1 <1 <1 <1

Glufosinate <10 <10 <10 <10 <10 <10 <10 <10

Glyphosate <10 <10 <10 <10 <10 <10 <10 <10

Acide aminométhylphosphonique (AMPA) <10 <10 <10 <10 <10 <10 <10 <10

Table 2:6. Formaldehyde, phthalates and pesticides in sanitary towels. Formaldehyde in mg/dm2, phthalates in mg/kg (µg/g), pesticides in ng/g. 16-01964 16-01966 16-01974 16-01975 16-01976 16-01977 16-01997 16-02000

Formaldehyde <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02

Phtalate de di-isobutyle (DiBP) <1 <1 <1 <1 <1 <1 <1 <1

Phtalate de dibutyle (DBP) <1 <1 <1 <1 <1 <1 <1 <1

Phtalate de benzylbutyle (BBP) <1 <1 <1 <1 <1 <1 <1 <1

Phtalate de bis(2-éthylhexyle) (DEHP) <1 <1 <1 <1 <1 <1 <1 <1

Phtalate de bis(2-methoxyéthyle) (DMEP) <1 <1 <1 <1 <1 <1 <1 <1

Phtalate de di-isopentyle (DPP) <10 <10 <10 <10 <10 <10 <10 <10

Phtalate de di-n-hexyle (DnHP) <1 <1 <1 <1 <1 <1 <1 <1

Phtalate de di-n-pentyle (DnPP) <1 <1 <1 <1 <1 <1 <1 <1

Glufosinate <10 <10 <10 <10 <10 <10 <10 <10

Glyphosate <10 <10 <10 <10 <10 <10 <10 <10 Acide aminométhylphosphonique (AMPA) <10 <10 <10 <10 32 <10 <10 <10

Appendix 3

Hazardous substances that may feature in feminine hygiene products based on registration in user sector PC39 in

REACH Annex XV and information about the hazard posed by the substance

Relevant substances both on group and substance level are presented in the following table as a cross-section between substances registered in the market sector

PC 39: Cosmetics, personal care products in Annex XV of REACH and substances with a harmonised classification as CMR or allergenic/sensitising in

accordance with CLP, classed as PBT substances and endocrine disrupting substances identified in IPCP’s report on endocrine disrupting substances i.

Substances used as biocides have also been included, and the substances included in the Candidate List.

Name CAS number EC number

Harmonised classification Biocides SVHC PBT

(E)-3-methyl-5-cyclopentadecen-1-one

63314-79-4, 82356-51-2

429-900-5

Skin sens. 1

(R)-p-mentha-1,8-diene

5989-27-5, 68606-81-5

227-813-5

Skin sens. 1

(S)-p-mentha-1,8-diene

5989-54-8

227-815-6

Skin sens. 1

1,2-Benzenedicarboxylic acid, di-C9-11- branched alkyl esters, C10-rich

68515-49-1

271-091-4

Endocrine UNEP



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number Name CAS number EC Harmonised classification Biocides SVHC PBT

1,3,4,6,7,8-hexahydro-4,6,6,7,8,8- hexamethylindeno[5,6-c]pyran

1222-05-5

214-946-9

Endocrine UNEP

1,3-bis(hydroxymethyl)-5,5- dimethylimidazolidine-2,4-dione

6440-58-0

229-222-8

Biocide

1-(2-hydroxyethyl)-1H-pyrazol-4,5- diyldiammoniumsulfate

155601-30-2

429-300-3

Skin sens. 1

1-(5,6,7,8-tetrahydro-3,5,5,6,8,8- hexamethyl-2-naphthyl)ethan-1-one

1506-02-1

216-133-4

Endocrine UNEP

1-(5,6,7,8-tetrahydro-3,5,5,6,8,8- hexamethyl-2-naphthyl)ethan-1-one

21145-77-7

244-240-6

Endocrine UNEP

1-chloro-2,3-epoxypropane

106-89-8

203-439-8

Carc. 1BSkin sens. 1

1-vinyl-2-pyrrolidone

88-12-0

201-800-4

Carc. 2

2,2-bis[[(1- oxoisooctadecyl)oxy]methyl]-1,3- propanediyl bis(isooctadecanoate)

62125-22-8

263-423-1

PBT

2,4-dihydroxybenzophenone

131-56-6

205-029-4

Endocrine UNEP

2,6-di-tert-butyl-p-cresol

128-37-0

204-881-4

Endocrine UNEP

2-[(2-hydroperoxybutan-2- yl)peroxy]butane-2-peroxol; butane- 2,2-diperoxol

1338-23-4

700-954-4

Biocide

2-dimethylaminoethyl methacrylate

2867-47-2

220-688-8

Skin sens. 1

number Name CAS number EC Harmonised classification Biocides SVHC PBT

2-hydroxyethyl methacrylate

868-77-9

212-782-2

Skin sens. 1

2-methyl-4-phenylpentanol

92585-24-5

402-770-7

Skin sens. 1

2-methyl-p-phenylenediamine

95-70-5

202-442-1

Skin sens. 1

2-methyl-p-phenylenediamine sulfate

615-50-9, 6369-59-1

210-431-8

Skin sens. 1

2-phenoxyethanol

122-99-6

204-589-7

Biocide

3,6,9.12- tetraazatetradecamethylenediamine

4067-16-7

223-775-9

Skin sens. 1

3,7-dimethylocta-2,6-dienenitrile

5146-66-7

225-918-0

Muta. 1B

4-aminophenol

123-30-8

204-616-2

Muta. 2

[[(phosphonomethyl)imino]bis[ethane- 2,1- diylnitrilobis(methylene)]]tetrakisphosphonic acid

15827-60-8

239-931-4

PBT

A mixture of: ethyl (2R,3R)-3- isopropylbicyclo[2.2.1]hept-5-ene-2- carboxylate; ethyl (2S,3S)-3- isopropylbicyclo[2.2.1]hept-5-ene-2- carboxylate

116044-44-1

427-090-8

Skin sens. 1

A mixture of: trans-4-acetoxy-4-methyl- 2-propyl-tetrahydro-2H-pyran; cis-4- acetoxy-4-methyl-2-propyl-tetrahydro- 2H-pyran

131766-73-9

412-450-9

Skin sens. 1

Name CAS number EC

number Harmonised classification Biocides SVHC PBT

Alcohols, C12-13, branched and linear, ethoxylated, sulfates, sodium salts

161074-79-9

500-513-4

PBT

Alkanes, C4-5

68475-60-5

270-654-1

Carc. 1AMuta. 1B

Aluminium, 6-hydroxy-5-[(4- sulfophenyl)azo]-2-naphthalenesulfonic acid complex

15790-07-5

239-888-1

PBT

Amines, polyethylenepoly-

68131-73-7

268-626-9

Skin sens. 1

Benzoic acid

65-85-0

200-618-2

Biocide

Benzophenone

119-61-9

204-337-6

Endocrine UNEP

Benzyl alcohol

100-51-6

202-859-9

Biocide

Bis(pentabromophenyl) ether

1163-19-5

214-604-9

Endocrine UNEP

SVHC

PBT

Boric acid

10043-35-3

233-139-2

Repr. 1B

Biocide

SVHC

Bronopol

52-51-7

200-143-0

Biocide

Butane

106-97-8

203-448-7

Carc. 1AMuta. 1B

Butanedioic acid, sulfo-, 4-C12-14 (even numbered)-alkyl esters, disodium salts

-

939-638-8

PBT

Name CAS number EC

number Harmonised classification Biocides SVHC PBT

Butyl methacrylate 97-88-1 202-615-1 Skin sens. 1

Cadmium chloride

10108-64-2, 35658-65-2

233-296-7

Carc. 1BMuta. 1BRepr. 1B

SVHC

Cadmium sulphide

1306-23-6

215-147-8

Carc. 1BMuta. 2Repr. 2

SVHC

Calcium dihydroxide

1305-62-0

215-137-3

Biocide

Calcium magnesium oxide

37247-91-9

253-425-0

Biocide

Calcium oxide

1305-78-8

215-138-9

Biocide

Cinnamaldehyde

104-55-2

203-213-9

Biocide

Citral

5392-40-5

226-394-6

Skin sens. 1

Citric acid

77-92-9, 5949-29-1

201-069-1

Biocide

Copper

7440-50-8

231-159-6

Biocide

Copper dihydroxide

20427-59-2

243-815-9

Biocide

Copper oxide

09 Oct

215-269-1

Biocide

Copper sulphate

7758-98-7, 7758-99-8

231-847-6

Biocide



Copper(II) carbonate--copper(II) hydroxide (1:1)

12069-69-1

235-113-6

Biocide

D-gluconic acid, compound with N,N''- bis(4-chlorophenyl)-3,12-diimino- 2,4,11,13- tetraazatetradecanediamidine (2:1)

18472-51-0

242-354-0

Biocide

Decanoic acid

334-48-5

206-376-4

Biocide

Diammonium peroxodisulphate

7727-54-0

231-786-5

Resp. sens. 1Skin sens. 1

Dibenzoyl peroxide

94-36-0

202-327-6

Skin sens. 1

Diboron trioxide

1303-86-2

215-125-8

Repr. 1B

Biocide

SVHC

Dichloromethane

75-09-2

200-838-9

Carc. 2

Diethyl phthalate

84-66-2

201-550-6

Endocrine UNEP

Dipotassium peroxodisulphate

7727-21-1

231-781-8

Resp. sens. 1Skin sens. 1

Disodium 6-hydroxy-5-[(2-methoxy-4- sulphonato-m-tolyl)azo]naphthalene-2- sulphonate

25956-17-6

247-368-0

PBT

Disodium disulphite

7681-57-4

231-673-0

Biocide

Disodium octaborate

12008-41-2, 12280-03-4

234-541-0

Repr. 1B

Biocide



Disodium peroxodisulphate

7775-27-1

231-892-1

Biocide

Disodium tetraborate, anhydrous

1303-96-4, 1330-43-4, 12179- 04-3

215-540-4

Repr. 1B

Biocide

SVHC

Distillates (petroleum), hydrotreated light paraffinic

64742-55-8

265-158-7

Carc. 1B

Ethanol

64-17-5, 97281-11-3

200-578-6

Biocide

Ethyl 4-hydroxybenzoate

120-47-8

204-399-4

Endocrine UNEP

Ethyl methacrylate

97-63-2

202-597-5

Skin sens. 1

Fatty acids, C16-18, zinc salts

91051-01-3

293-049-4

PBT

Formaldehyde

50-00-0

200-001-8

Carc. 1BMuta. 2Skin sens. 1

Biocide

Fuel gases

68476-26-6

270-667-2

Carc. 1AMuta. 1B

Gases (petroleum), depropanizer dry, propene-rich

68477-90-7

270-772-3

Carc. 1AMuta. 1B

Geraniol

106-24-1

203-377-1

Biocide

Glutaral

111-30-8

203-856-5

Resp. sens. 1

Biocide

Glycollic acid

79-14-1

201-180-5

Biocide



Glyoxal

107-22-2

203-474-9 Muta. 2Skin sens. 1

Biocide

Hexa-2,4-dienoic acid

110-44-1

203-768-7

Biocide

Hydrocarbons, C6, isoalkanes, <5% n- hexane

64742-49-0

931-254-9 Carc. 1BMuta. 1B

Hydrocarbons, C7, n-alkanes, isoalkanes, cyclics

64742-49-0

927-510-4 Carc. 1BMuta. 1B

Hydrocarbons, C7-C9, isoalkanes

64741-66-8

921-728-3 Carc. 1BMuta. 1B

Hydrogen peroxide

7722-84-1

231-765-0

Biocide

Isobutane

75-28-5

200-857-2 Carc. 1AMuta. 1B

L-(+)-lactic acid

79-33-4

201-196-2

Biocide

L-p-mentha-1(6),8-dien-2-one

6485-40-1

229-352-5 Skin sens. 1

Lauric acid

143-07-7

205-582-1

Biocide

Lubricating oils

74869-22-0

278-012-2 Carc. 1B

Maleic acid

110-16-7

203-742-5 Skin sens. 1

Maleic anhydride

108-31-6

203-571-6 Resp. sens. 1Skin sens. 1



Mercury

7439-97-6

231-106-7

Repr. 1B

Methanol

67-56-1

200-659-6

PBT

Methenamine

100-97-0

202-905-8

Skin sens. 1

Methoxycarbonyloxycyclooct-4-ene

87731-18-8

401-620-8

Skin sens. 1

Methyl 4-hydroxybenzoate

99-76-3

202-785-7

Endocrine UNEP

Methyl methacrylate

80-62-6

201-297-1

Skin sens. 1

Methyloxirane

75-56-9

200-879-2

Carc. 1BMuta. 1B

SVHC

N-(n-dodecyl)pyrrolidinone

2687-96-9

403-730-1

Skin sens. 1

N-hexane

110-54-3

203-777-6

Repr. 2Endocrine UNEP

Nonanoic acid

112-05-0

203-931-2

Biocide

Octamethylcyclotetrasiloxane

556-67-2

209-136-7

Repr. 2Endocrine UNEP

Octanoic acid

124-07-2

204-677-5

Biocide

Oxybenzone

131-57-7

205-031-5

Endocrine UNEP



p-phenylenediamine 106-50-3 203-404-7 Skin sens. 1

Pentapotassium bis(peroxymonosulphate) bis(sulphate)

70693-62-8

274-778-7

Biocide

Petrolatum

8009-03-8

232-373-2

Carc. 1B

Petrolatum (petroleum), clay-treated

100684-33-1

309-706-6

Carc. 1B

Petrolatum (petroleum), hydrotreated

92045-77-7

295-459-9

Carc. 1B

Petrolatum (petroleum), oxidized

64743-01-7

265-206-7

Carc. 1B

Potassium (E,E)-hexa-2,4-dienoate

590-00-1, 24634-61-5

246-376-1

Biocide

Potassium hydroxide

1310-58-3

215-181-3

PBT

Propan-1-ol

71-23-8

200-746-9

Biocide

Propan-2-ol

67-63-0

200-661-7

Biocide

Propyl 4-hydroxybenzoate

94-13-3

202-307-7

Endocrine UNEP

Pyrithione zinc

13463-41-7

236-671-3

Biocide

Resin acids and Rosin acids, esters with diethylene glycol

68153-38-8

268-884-2

PBT

number Name CAS number EC - Harmonised classification

Biocides SVHC PBT

Resorcinol

108-46-3

203-585-2

Endocrine UNEP

Rosin

8050-09-7

232-475-7

Skin sens. 1

Salicylic acid

69-72-7

200-712-3

Biocide

Silicon dioxide

7631-86-9, 112926-00-8

231-545-4

Biocide

Slack wax (petroleum)

64742-61-6

265-165-5

Carc. 1B

Slack wax (petroleum), clay-treated

90669-78-6

292-660-3

Carc. 1B

Slack wax (petroleum), hydrotreated

92062-09-4

295-523-6

Carc. 1B

Sodium dichromate

7789-12-0, 10588-01-9

234-190-3

Carc. 1BMuta. 1BRepr. 1BResp. sens. 1Skin sens. 1

SVHC

Sodium hypochlorite

7681-52-9

231-668-3

Biocide

Sodium N-(hydroxymethyl)glycinate

70161-44-3

274-357-8

Biocide

tert-butyl-4-methoxyphenol

121-00-6, 25013-16-5

246-563-8

Endocrine UNEP

tetraethyl N,N'- (methylenedicyclohexane-4,1-diyl)bis- .sc.dl.sc.-aspartate

136210-30-5

429-270-1

Skin sens. 1

number

i The International Panel on Chemical Pollution (IPCP), 2016. Overview Report I: A Compilation of Lists of Chemicals Recognised as Endocrine Disrupting Chemicals (EDCs) or

Suggested as Potential EDCs

Name CAS number EC - Harmonised classification Biocides SVHC PBT

Triclosan

3380-34-5

222-182-2

Endocrine UNEP

Biocide

Triphenyl phosphate

115-86-6

204-112-2

Endocrine UNEP

Troclosene sodium

2893-78-9, 51580-86-0

220-767-7

Biocide

Vinyl acetate

108-05-4

203-545-4

Carc. 2

Appendix 4

Table 4.1 Substances identified in qualitative analysis (screening) Substances identified in the qualitative analysis. Substances marked in yellow fulfil the criteria in accordance with harmonised and notified (if they deviate from the

harmonised) classifications for the criteria (Carc 1A, 1B, 2, Muta 1A, 1B, 2, Repr 1A, 1B, 2) and allergenic/sensitising (Resp. sens 1, Skin sens 1). Data obtained from

.https://echa.europa.eu/sv

Branched 4-nonylphenol ethoxylate 127087-87-0 Skin Sens 1, Repr 2

Polyethelene glycol 25322-68-3

Methyl dihydrojasminate, 37172-53-5

D4, Octamethylcyclotetrasiloxane, 556-67-2 Repr 2

D5, Decamethylcyclopentasiloxane 541-02-6

D6, Dodecamethylcyclohexasiloxane, 540-97-6

D7, Tetradecamethylcycloheptasiloxane, 107-50-6

D8, Hexadecamethylcyclooctasiloxane, 556-68-3

D9, Octadecamethylcyclononasiloxane 556-71-8

Benzophenone 119-61-9 Carc 2, Skin Sens 1B

Propylbenzoic acid 2438-05-03

Abietic acid 514-10-3 Skin Sens. 1

Alcohol ethoxylate 68439-46-3



C.I.N.: 556116-2446

VAT no.: SE556116244601






www.ivl.se Fax: +46(0)10-788 65 90 Fax: + 46 (0)10-788 68 90

Harmonised Notified classification classification CAS number Subst

ance

https://echa.europa.eu/sv

http://www.ivl.se/

Table 4.2 Substances identified in a separate evaluation in collaboration with the Swedish Chemicals Agency

The extract from the sample Sanitary Towels 1-7 (6496-6502 and associated blanks) has, in collaboration with Stellan Fisher, Swedish Chemicals Agency, been

evaluated against a substance database which also includes the indices “exposure score” and “hazard score”. A higher exposure score means that the substance is

more commonly found in society; a higher hazard score means that the substance is deemed to entail higher risks. A hazard score of “-” means that the information is

missing. From the hits obtained, those subjectively assessed as interesting have been selected. Rows which sit together in the table, without separating grey rows,

indicate co-eluting chromatographic peaks. In some cases, alternative hits for the same peak are given. These have been arranged in descending exposure score and

then descending hazard score.

Name I

Name II

CAS no.

MF

Re

tTim

e

O

bse

rved

mas

s (m

/z)

A

dd

uct

s

O

bse

rved

neu

tral

mas

s (D

a)

E

xpec

ted

neu

tral

mas

s (D

a)

Mas

s er

ror

(pp

m)

Exp

osu

reS

core

-Hu

m (

max

27)

Haz

Sco

re_H

um

Ch

ron

ic(1

-9)

2-Pyrrolidinone, 1-ethyl- 1-Ethyl-2-pyrrolidinone 2687-91-4 C6H11NO 2.27 114.0915 +H 113.08367 113.08406 3.45 24 9

Benzenesulfonic acid, dodecyl- Dodecylbenzenesulfonic acid 27176-87-0 C18H30O3S 3.17 349.1828 +Na 326.193 326.19157 -4.4 24 7

Naphthalenesulfonic acid, dipentyl- Dipentylnaphthalenesulphonic acid 61702-94-1 C20H28O3S 3.17 349.1828 +H 348.17498 348.17592 2.7 2 6

Stannane, tributyl[[(4-dodecylphenyl)sulfonyl]oxy]- Tributyl(((p-

dodecylphenyl)sulphonyl)oxy)stannane

85938-51-8

C18H30O3S.

3.17

349.1828

+Na

326.193

326.19157

-4.4

2

-

2-Cyclopentene-1-acetic acid, ethyl ester 2-Cyclopentene-1-acetic acid, ethyl ester 15848-49-4 C9H14O2 4.8 155.1065 +H 154.0987 154.09938 4.43 9 -

2-Propenoic acid, cyclohexyl ester Cyclohexyl acrylate 3066-71-5 C9H14O2 4.8 155.1065 +H 154.0987 154.09938 4.43 2 4

Neodecanoic acid Nickel(2+) neodecanoate 85508-44-7 C10H20O2. 6.55 195.1354 +Na 172.14555 172.14633 4.56 2 9

Cyclopentaneacetic acid, 3-oxo-2-pentyl-, methyl Methyl dihydrojasmonate 24851-98-7 C13H22O3 8.24 227.164 +H 226.15618 226.1569 3.18 24 -

Name I

Name II

CAS no.

MF

Re

tTim

e

O

bse

rved

mas

s (m

/z)

A

dd

uct

s

O

bse

rved

neu

tral

mas

s (D

a)

E

xpec

ted

neu

tral

mas

s (D

a)

Mas

s er

ror

(pp

m)

Exp

osu

reS

core

-Hu

m (

max

27)

Haz

Sco

re_H

um

Ch

ron

ic(1

-9)

ester

Peroxide, 1,1-dimethylethyl 1-methyl-1-phenylethyl

Peroxide, 1,1-dimethylethyl 1-methyl-1- phenylethyl

3457-61-2

C13H20O2

8.36

209.1534

+H

208.14556

208.14633

3.72

17

4

4,7-Methano-3aH-indene-3a-carboxylic acid,

octahydro-, ethyl ester, (3a.alpha.,

4.alpha.,7.alpha.,7a.alpha.)-

Ethyl (3aR,4S,7R,7aR)-octahydro-3aH-4,7-

methanoindene-3a-carboxylate rel

80657-64-3

C13H20O2

8.36

209.1534

+H

208.14556

208.14633

3.72

15

4

Ethanol, 2-(3,3-dimethylbicyclo[2.2.1]hept-2- ylidene)-, 1-acetate

Ethanol, 2-(3,3-dimethylbicyclo[2.2.1]hept-2- ylidene)-, acetate

2226-03-1

C13H20O2

8.36

209.1534

+H

208.14556

208.14633

3.72

2

-

Cyclohexene, 1-methyl-4-(1-methylethenyl)- Limonene 138-86-3 C10H16 8.38 137.1325 +H 136.12467 136.1252 3.92 25 7

Cyclohexene, 1-methyl-3-(1-methylethylidene)- trans-1-methyl-4-(1-methylvinyl)cyclohexene 6876-12-6 C10H16 8.38 137.1325 +H 136.12467 136.1252 3.92 18 7

Cyclohexene, 1-methyl-4-(1-methylethenyl)-, trans- 1,7,7-trimethyltricyclo[2.2.1.02,6]heptane 508-32-7 C10H16 8.38 137.1325 +H 136.12467 136.1252 3.92 7 4

Cyclohexene, 1-methyl-5-(1-methylethenyl)-, (R)- Cyclohexene, 1-methyl-3-(1-methylethylidene)- 17092-80-7 C10H16 8.38 137.1324 +H 136.12459 136.1252 4.48 4 4

Tricyclo[2.2.1.02,6]heptane, 1,3,3-trimethyl- (R)-1-methyl-5-(1-methylvinyl)cyclohexene 1461-27-4 C10H16 8.38 137.1324 +H 136.12459 136.1252 4.48 2 6

Tricyclo[2.2.1.02,6]heptane, 1,7,7-trimethyl- 1,3,3-trimethyltricyclo[2.2.1.02,6]heptane 488-97-1 C10H16 8.38 137.1324 +H 136.12459 136.1252 4.48 2 4

D-Galactitol, 3,6-anhydro-1-O-(1-oxododecyl)- Sorbitan, monododecanoate 8028-02-2 C18H34O6 9.98 347.2423 +H 346.23445 346.23554 3.14 2 -

D-Galactitol, 3,6-anhydro-1-O-(1-oxododecyl)- Sorbitan, monododecanoate 8028-02-2 C18H34O6 9.99 369.2241 +Na 346.23432 346.23554 3.52 2 -

Neodecaneperoxoic acid, 1,1,3,3-tetramethylbutyl ester

Neodecaneperoxoic acid, 1,1,3,3- tetramethylbutyl ester

51240-95-0

C18H36O3

10.06

310.2371

+NH4

300.26535

300.26644

3.64

10

-

Benzenemethanol, 3,5-bis(1,1-dimethylethyl)-4-

hydroxy-, .alpha.-propanoate 3,5-di-tert-butyl-4-hydroxybenzyl propionate

89022-83-3

C18H28O3

10.06

315.1925

+Na

292.20274

292.20384

3.8

2

4

Name I

Name II

CAS no.

MF

Re

tTim

e

O

bse

rved

mas

s (m

/z)

A

dd

uct

s

O

bse

rved

neu

tral

mas

s (D

a)

E

xpec

ted

neu

tral

mas

s (D

a)

Mas

s er

ror

(pp

m)

Exp

osu

reS

core

-Hu

m (

max

27)

Haz

Sco

re_H

um

Ch

ron

ic(1

-9)

D-Galactitol, 3,6-anhydro-1-O-(1-oxododecyl)- Sorbitan, monododecanoate 8028-02-2 C18H34O6 10.16 347.2424 +H 346.23458 346.23554 2.78 2 -

1-Phenanthrenecarboxylic acid, 1,2,3,4,4a,9,10,10a-

octahydro-1,4a-dimethyl-7-(1-methylethyl)-, (1R,4aS,10aR)-

Dehydroabietic acid

1740-19-8

C20H28O2

10.2

323.1977

+Na

300.20792

300.20893

3.35

20

2

Androst-4-ene-3,17-dione, 1-methyl-, (1?)- Androst-4-ene-3,17-dione, 1-methyl-, (1?)- 4136-62-3 C20H28O2 10.2 323.1977 +Na 300.20792 300.20893 3.35 5 -

1,2,3-Propanetricarboxylic acid, 2-(acetyloxy)-, 1,2,3-

tributyl ester Acetyl tributyl citrate

77-90-7

C20H34O8

10.29

425.2139

+Na

402.2241

402.22537

3.16

25

3

1,2,3-Propanetricarboxylic acid, 2-(acetyloxy)-, 1,2,3- tributyl ester

Acetyl tributyl citrate

77-90-7

C20H34O8

10.29

403.232

+H

402.2242

402.22537

2.91

25

3

1,3,2-Dioxaborinane, 2,2'-[2,2-dimethyl-1,3- propanediylbis(oxy)]bis[5,5-dimethyl-


5456-05-3

C15H30B2O6

10.54

351.2134

+Na

328.22364

328.22285

- 2.41

2

-

1,3,2-Dioxaborinane, 2,2'-[2,2-dimethyl-1,3-

propanediylbis(oxy)]bis[5,5-dimethyl-


propanediylbis(oxy)]bis[5,5-dimethyl- 5456-05-3

C15H30B2O6

10.54

329.2317

+H

328.22386

328.22285

-

3.09

2

-



5456-05-3

C15H30B2O6

10.54

351.2134

+Na

328.22364

328.22285

- 2.41

2

-



5456-05-3

C15H30B2O6

10.54

329.2317

+H

328.22386

328.22285

- 3.09

2

-

Phenol, 4-(3,4,5-trimethylheptyl)-

Phenol, dodecyl-, branched

121158-58-

5 C16H26O

10.66

257.1872

+Na

234.19739

234.19836

4.14

23

3

2H-Pyran, 2-(3,3-dimethylbicyclo[2.2.1]hept-2-

yl)tetrahydro-4,6-dimethyl-, didehydro deriv.

2-(3,3-dimethylbicyclo[2.2.1]hept-2-

yl)tetrahydro-4,6-dimethyl-2H-pyran, didehydro derivative

71850-60-7

C16H26O

10.66

257.1872

+Na

234.19739

234.19836

4.14

2

4

Name I

Name II

CAS no.

MF

Re

tTim

e

O

bse

rved

mas

s (m

/z)

A

dd

uct

s

O

bse

rved

neu

tral

mas

s (D

a)

E

xpec

ted

neu

tral

mas

s (D

a)

Mas

s er

ror

(pp

m)

Exp

osu

reS

core

-Hu

m (

max

27)

Haz

Sco

re_H

um

Ch

ron

ic(1

-9)

Peroxydicarbonic acid, bis(3,5,5-trimethylhexyl)

ester


ester 4113-15-9

C20H38O6

10.79

397.2556

+Na

374.26578

374.26684

2.82

2

-


ester


ester 4113-15-9

C20H38O6

10.79

375.2737

+H

374.26592

374.26684

2.46

2

-

1-Phenanthrenecarboxylic acid, 1,2,3,4,4a,9,10,10a-

octahydro-1,4a-dimethyl-7-(1-methylethyl)-,

(1R,4aS,10aR)-

Dehydroabietic acid

1740-19-8

C20H28O2

10.93

301.2157

+H

300.20784

300.20893

3.62

20

2

Androst-4-ene-3,17-dione, 1-methyl-, (1?)- Androst-4-ene-3,17-dione, 1-methyl-, (1?)- 4136-62-3 C20H28O2 10.93 301.2157 +H 300.20784 300.20893 3.62 5 -

19-Norpregn-5(10)-en-3-one, 17-hydroxy-, (17?)- 19-Norpregn-5(10)-en-3-one, 17-hydroxy-, (17?)- 6318-07-6 C20H30O2 11.15 325.2134 +Na 302.22355 302.22458 3.41 2 -

1-Phenanthrenecarboxylic acid,

1,2,3,4,4a,4b,5,6,7,9,10,10a-dodecahydro-1,4a-

dimethyl-7-(1-methylethylidene)-, [1R-

(1.alpha.,4a.beta.,4b.alpha.,10a.alpha.)]-

Neoabietic acid

471-77-2

C20H30O2

11.15

325.2134

+Na

302.22355

302.22458

3.41

3

-

Gona-2,5(10)-dien-17-ol, 13-ethyl-3-methoxy-,

(17.beta.)-(.+-.)-

Gona-2,5(10)-dien-17-ol, 13-ethyl-3-methoxy-,

(17.beta.)-(.+-.)- 1038-28-4

C20H30O2

11.15

325.2134

+Na

302.22355

302.22458

3.41

5

-

Cyclopropanecarboxylic acid, 2,2-dimethyl-3-(2-

methyl-1-propenyl)-, 2-methyl-4-oxo-3-(2-

propynyl)-2-cyclopenten-1-yl ester

Prallethrin

23031-36-9

C19H24O3

11.34

323.1623

+Na

300.17252

300.17254

0.07

13

7

Androst-4-ene-3,17-dione, 6,19-epoxy-, (6.beta.)- Androst-4-ene-3,17-dione, 6,19-epoxy-, (6.beta.)- 6563-83-3 C19H24O3 11.34 323.1623 +Na 300.17252 300.17254 0.07 2 4

Gona-2,5(10)-dien-17-ol, 13-ethyl-3-methoxy-, (17.beta.)-(.+-.)-


1038-28-4

C20H30O2

11.42

325.2132

+Na

302.22343

302.22458

3.82

5

-




Neoabietic acid

471-77-2

C20H30O2

11.42

325.2132

+Na

302.22343

302.22458

3.82

3

-

Name I

Name II

CAS no.

MF

Re

tTim

e

O

bse

rved

mas

s (m

/z)

A

dd

uct

s

O

bse

rved

neu

tral

mas

s (D

a)

E

xpec

ted

neu

tral

mas

s (D

a)

Mas

s er

ror

(pp

m)

Exp

osu

reS

core

-Hu

m (

max

27)

Haz

Sco

re_H

um

Ch

ron

ic(1

-9)


19-Norpregn-5(10)-en-3-one, 17-hydroxy-, (17?)- 19-Norpregn-5(10)-en-3-one, 17-hydroxy-, (17?)- 6318-07-6 C20H30O2 11.42 303.2309 +H 302.2231 302.22458 4.89 2 -



1038-28-4

C20H30O2

11.6

325.2133

+Na

302.22352

302.22458

3.51

5

-





Neoabietic acid

471-77-2

C20H30O2

11.6

325.2133

+Na

302.22352

302.22458

3.51

3

-

19-Norpregn-5(10)-en-3-one, 17-hydroxy-, (17?)- 19-Norpregn-5(10)-en-3-one, 17-hydroxy-, (17?)- 6318-07-6 C20H30O2 11.6 325.2133 +Na 302.22352 302.22458 3.51 2 -

Piperidine, 4,4-bis[(1,1-dimethylethyl)dioxy]-2,2,6,6-

tetramethyl-

4,4-Bis((tert-butyl)dioxy)-2,2,6,6-

tetramethylpiperidine

75279-29-7

C17H35NO4

11.73

327.2289

+NH4

317.25717

317.25661

-

1.78

2

4

Dodecanoic acid, 1-methylethyl ester Dodecanoic acid, 1-methylethyl ester 10233-13-3 C15H30O2 11.75 265.2135 +Na 242.22373 242.22458 3.5 24 -

Dodecanoic acid, propyl ester Propyl laurate 3681-78-5 C15H30O2 11.75 265.2135 +Na 242.22373 242.22458 3.5 3 4

9-Octadecenoic acid

Octadec-9-enoic acid

2027-47-6

C18H34O2

11.77

305.247

+Na

282.25715

282.25588

- 4.49

3

4

4,5-Epoxycyclohexane-1,2-dicarboxylic acid, di-(2- ethylhexyl) ester

4,5-Epoxycyclohexane-1,2-dicarboxylic acid, di- (2-ethylhexyl) ester

10138-36-0

C24H42O5

11.91

433.292

+Na

410.30216

410.30322

2.59

3

4


propanediylbis(oxy)]bis[5,5-dimethyl-


propanediylbis(oxy)]bis[5,5-dimethyl- 5456-05-3

C15H30B2O6

11.97

327.2266

NoAdduct

327.22656

327.22648

-

0.25

2

-

Piperidine, 4,4-bis[(1,1-dimethylethyl)dioxy]-2,2,6,6- 4,4-Bis((tert-butyl)dioxy)-2,2,6,6- 75279-29-7 C17H35NO4 11.98 327.2268 +NH4 317.25507 317.25661 4.86 2 4

Name I

Name II

CAS no.

MF

Re

tTim

e

O

bse

rved

mas

s (m

/z)

A

dd

uct

s

O

bse

rved

neu

tral

mas

s (D

a)

E

xpec

ted

neu

tral

mas

s (D

a)

Mas

s er

ror

(pp

m)

Exp

osu

reS

core

-Hu

m (

max

27)

Haz

Sco

re_H

um

Ch

ron

ic(1

-9)

tetramethyl- tetramethylpiperidine

Isooctadecanoic acid, monoester with 1,2,3- propanetriol

Isooctadecanoic acid, monoester with 1,2,3- propanetriol

66085-00-5

C21H42O4

12.07

381.297

+Na

358.30717

358.30831

3.19

14

-

Cinchonan-9-ol, (8a,9R)-, mono[[(S)-[(1R)-2-methyl-

1-(1-oxopropoxy)propoxy](4-

phenylbutyl)phosphinyl]acetate] (salt)

[R-(R*S*)][[2-Methyl-1-(1-

oxopropoxy)propoxy]-(4-

phenylbutyl)phosphinyl]acetic acid (-)-

cinchonidine (1:1) salt

137590-32-

0

C19H29O6P.

12.19

385.1779

+H

384.17009

384.17018

0.22

2

4

Cyclopropanecarboxylic acid, 2,2-dimethyl-3-(2-

methyl-1-propenyl)-, 2-methyl-4-oxo-3-(2,4-

pentadienyl)-2-cyclopenten-1-yl ester, [1R-

[1.alpha.[S*(Z)],3.beta.]]-

Pyrethrin I

121-21-1

C21H28O3

12.25

351.1935

+Na

328.20374

328.20384

0.31

15

7

Cinchonan-9-ol, (8a,9R)-, mono[[(S)-[(1R)-2-methyl-

1-(1-oxopropoxy)propoxy](4-

phenylbutyl)phosphinyl]acetate] (salt)

[R-(R*S*)][[2-Methyl-1-(1-

oxopropoxy)propoxy]-(4-

phenylbutyl)phosphinyl]acetic acid (-)-

cinchonidine (1:1) salt

137590-32-

0

C19H29O6P.

12.34

385.1778

+H

384.17

384.17018

0.46

2

4



C.I.N.: 556116-2446

VAT no.: SE556116244601

Registered office: Stockholm

www.ivl.se



Tel: +46 (0)10-788 65 00

Fax: +46(0)10-788 65 90



Tel: +46 (0)10-788 65 00

Fax: + 46 (0)10-788 68 90

Appendix 5

Substances occurring in more than one of the lists (Appendices 1, 3, 4)

Substance CAS number Alternative name Selection Literature Screening

Butyl methacrylate 97-88-1 x x

Formaldehyde 50-00-0 x x

Isopropyl alcohol 67-63-0 x x

Vinyl acetate 108-05-4 x x

Glutaraldehyde 111-30-8 x x

Octamethylcyclotetrasiloxane 556-67-2 D4 x x x

Decamethylcyclopentasiloxane 541-02-6 D5 x x

Triclosan 3380-34-5 x x

Benzophenone 119-61-9 x x

Abietic acid 514-10-3 x x

http://www.ivl.se/



C.I.N.: 556116-2446

VAT no.: SE556116244601

Registered office: Stockholm

www.ivl.se



Tel: +46 (0)10-788 65 00

Fax: +46(0)10-788 65 90



Tel: +46 (0)10-788 65 00

Fax: + 46 (0)10-788 68 90

Appendix 6

Substances proposed for quantitative analysis

Substance

CAS number

EC number

Trivial name

Reason for inclusion in the list

Other reason for inclusion in the list


Product type

Harmonised Classification

Notified Classifications

Abietic acid

514-10-3

208-178-3

Screening,

mentioned in

the literature

Cross-section

between lists

Adhesive and

binding agent

Sanitary towels

Skin Sens 1

Formaldehyde

50-00-0

200-001-8

mentioned in

Nordic

ecolabelling

criteria

cross-section

between the

lists

residues in dried adhesive

All

Skin Sens 1,

Carc1B, Muta 2

Glutaraldehyde

111-30-8

203-856-5

Glutaral


criteria


lists

disinfection

All

Skin Sens 1A

Butyl methacrylate

97-88-1

202-615-1

mentioned in

the literature


lists

superabsorbents

All

Skin Sens 1

http://www.ivl.se/

Substance

CAS number

EC number

Trivial name


Other reason

for inclusion

in the list


Product type



Isopropyl alcohol

67-63-0

200-661-7

detected in the study on

Always sanitary towels


lists

disinfection? Residues

solvent?

All

Vinyl acetate

108-05-4

203-545-4

detected in the study on

Always sanitary towels


lists

polyvinyl acetate

All

Carc 2

Triclosan

3380-34-5

222-182-2


criteria


lists

anti-bacterial

All

Benzophenone

119-61-9

204-337-6

screening

menstrual cups

cross-section between lists and

screening

menstrual cups

Skin Sens 1B,

Carc 2

Octamethylcyclotetrasiloxan

e

556-67-2

D4


criteria


screening

silicone

menstrual cups

Repr 2

Decamethylcyclopentasiloxa

ne

541-02-6

D5

mentioned in

Nordic

ecolabelling

criteria


screening

silicone

menstrual

cups

Nonylphenol ethoxylates 127087-87-

0

500-315-8

Screening

sanitary towels

Skin Sens 1,

Repr 2

Substance

CAS number

EC number

Trivial name


Other reason for inclusion

in the list


Product type



mentioned in

the literature

2,3,7,8-TetraCDD

1746-01-6 217-122-7 as a potent

dioxin

to ease concerns

bleaching cotton tampons,

sanitary towels

mentioned in

the literature

1,2,3,7,8-PentaCDD

40321-76-4 694-814-9 as a potent

dioxin

to ease

concerns

bleaching cotton tampons,

sanitary towels

OctaCDD

3268-87-9

694-813-3

measurable concentrations in the

literature study

to ease concerns

bleaching cotton

tampons,

sanitary

towels

measurable

concentrations

in the literature

study, tampons,

Glyphosate 70393-85-0 consumer concerns

to ease concerns

pesticides sanitary towels

measurable

concentrations

in the literature

Aminomethylphosphonic

acid (AMPA)

1066-51-9 623-325-5 study,

consumer concerns

to ease concerns

pesticides tampons,

sanitary towels

several different

substances, some

are

PAH 16 substances


literature study

primarily

sanitary

towels

classified as per

our criteria

Substance

CAS number

EC number

Trivial name



in the list


Product type



Malaoxon/Malathion

121-75-5

204-497-7


literature study

pesticides

tampons

Skin Sens1

Dichlofluanid

1085-98-9

214-118-7


literature study

pesticides

tampons

Skin Sens1

Mecarbam

2595-54-2

219-993-9


literature study

pesticides

tampons

Procymidone

32809-16-8

measurable

concentrations

in the literature

study

pesticides

tampons

Repr1B

Methidathion

950-37-8

213-449-4


literature study

pesticides

tampons

Skin Sens1

Fensulfothion

115-90-2

204-114-3


literature study

pesticides

tampons

Piperonyl Butoxide

51-03-6

200-076-7

measurable concentrations in the literature study

pesticides

tampons

Repr2

Substance

CAS number

EC number

Trivial name



in the list


Product type



several different

substances, some

are

classified

Arsenic and its

compounds

mentioned in

Nordic

ecolabelling

residues

from

production

all apart from

menstrual cups

as per our

criteria

Organotin compounds

mentioned in

Nordic

ecolabelling

residues

from

production

all apart from

menstrual cups

2,2-dichloro-4,4-

methylenedianiline

101-14-4

202-918-9

MOCA

mentioned in

Nordic

ecolabelling

residues

from

production

all apart from

menstrual cups

Carc 1B

diisobutyl phthalate

84-69-5

201-553-2

DIBP

mentioned in

Nordic

ecolabelling

residues

from

production

all apart from

menstrual cups

Repr 1B

Antimony trioxide

1309-64-4

215-175-0

mentioned in

Nordic

ecolabelling

residues

from

production

all apart from

menstrual cups

Carc 2

Styrene

100-42-5

202-851-5

mentioned in

Nordic

ecolabelling

residues

from

production

all apart from

menstrual cups

Repr2

Caprolactam

105-60-2

203-313-2

mentioned in

Nordic

ecolabelling

residues

from

production

all apart from

menstrual cups

adipic acid

124-04-9

204-673-3

mentioned in

Nordic

ecolabelling

residues

from

production

all apart from

menstrual cups

Substance

CAS number

EC number

Trivial name



in the list


Product type



Dimethylacetamide

127-19-5

204-826-4

DMAc

mentione

d in

Nordic

ecolabelli

ng

residues

from

production

all apart from

menstrual cups

Repr 1B

dimethylformamide

..68-12-02

200-679-5

DMF

mentione

d in

Nordic

ecolabelli

ng

residues

from

production

all apart from

menstrual cups

Repr 1B

acrylamide

79-06-01

201-173-7

mentione

d in

Nordic

ecolabelli

ng

residues

from

production

sanitary towels,

Skin Sens1,

Muta 1B,

Repr2, Carc

1B

methylisothiazolinone

2682-20-4

220-239-6

MI

mentioned in

Nordic

ecolabelling

residues

from

production

wet wipes

Skin Sens1

methylchloroisothiazolinone

26172-55-4

247-500-7

CMI

mentione

d in

Nordic

ecolabelli

ng

residues

from

production

wet wipes

Skin Sens1

Box 2, 172 13 Sundbyberg

+46(0)8-519 41 100

Visiting and delivery address

Esplanaden 3A, 172 67 Sundbyberg

[email protected]

www.kemikalieinspektionen.se

mailto:[email protected]

http://www.kemikalieinspektionen.se/

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