existing european health risk reduction options …

EXISTING EUROPEAN HEALTH RISK REDUCTION OPTIONS ASSOCIATED WITH CONSUMER PRODUCT EMISSIONS WP7 – DELIVERABLE 9 Authors: Paolo Carrer, Marilena Trantallidi Department of Occupational and Environmental Health, University of Milan, Italy April 2013

This report arises from the project EPHECT which has received funding from the European Union, in the framework of the Health Programme.

“© UMil All rights on the materials described in this document rest with UMil. This document is produced in the frame of the EPHECT‐project. The EPHECT‐project is co‐funded by the European Union in the framework of the health Programmes 2006‐2013. The information and views set out in this document are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf, nor the authors may be held responsible for the use which may be made of the information contained herein. Reproduction is authorized provided the source is acknowledged.”

Distribution List

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DISTRIBUTION LIST

EPHECT associated partners

EPHECT collaborative partners

Summary

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SUMMARY

European air quality policies should focus on indoor exposures to identify, control and eliminate indoor sources of pollution in order to promote health in the indoor environment. In this context, risk reduction options should be implemented in case of hazardous emissions from consumer products, one of the major sources of pollution indoors. EPHECT can contribute to the development of efficient risk management guidance and formulation of policy options in order to achieve an efficient reduction of risk related to the household use of consumer products. This aim can be reached after the evaluation of the outcome of the health risk assessment procedure conducted in the framework of the project for priority compounds emitted indoors from selected consumer products. The main purpose of this document is to provide an overview of the European health risk reduction options related to emissions from consumer products, developed mainly in the frame of the INDEX project (Kotzias et al., 2005), the ENVIE co-ordination action (Oliveira Fernandes et al., 2008) and the REACH Regulation (EC) No 1907/2006. The existing options can be consulted either to be implemented directly or to be used as a basis for the development of new ones in order to ensure optimal indoor air quality. Besides the indication of the main risk reduction measures currently available in Europe, this report also focuses on two concepts to be followed in the framework of EPHECT. First, the prioritization of the risk reduction options, i.e. from “source control” to “exposure control”, according to the “ENVIE approach”, and second, the preference on options that are formulated based on the product’s emission patterns, rather than - as currently promoted by EU legislation - on its chemical content, for the specification of safety conditions and limits. In the framework of EPHECT, options to reduce risk related to chemical emissions from consumer products, together with a health risk assessment methodology, are recommended. These proposals should be further developed in collaboration with policy makers and industry so that existing knowledge is enhanced and an up-to-date, scientifically-supported implementation of policies and risk reduction options related to the indoor use of consumer products in the EU is achieved.

Table of contents

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TABLE OF CONTENTS

DISTRIBUTION LIST .............................................................................................................................................. i

SUMMARY .......................................................................................................................................................... ii

TABLE OF CONTENTS ......................................................................................................................................... iii

LIST OF ACRONYMS ........................................................................................................................................... iv

CHAPTER 1. INTRODUCTION ..............................................................................................................................1

CHAPTER 2. DEVELOPING STRATEGIES FOR RISK REDUCTION ...........................................................................3

CHAPTER 3. EXISTING EU RISK REDUCTION OPTIONS ........................................................................................4

3.1 The INDEX approach ........................................................................................................................... 4

3.2 The ENVIE approach ........................................................................................................................... 5

3.3 The REACH approach .......................................................................................................................... 7

CHAPTER 4. THE EPHECT CONTRIBUTION ....................................................................................................... 12

CHAPTER 5. CONCLUSIONS.............................................................................................................................. 13

REFERENCES .................................................................................................................................................... 15

List of acronyms

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LIST OF ACRONYMS

BPD Biocidal Products Directive CEN European Committee for Standardization CLP Classification, Labelling and Packaging ES Exposure Scenario GPSD General Product Safety Directive IAQ Indoor Air Quality LCI Lowest Concentration of Interest OC Operational Condition PPE Personal Protective Equipment REACH Registration, Evaluation, Authorisation and Restriction of Chemicals RMM Risk Management Measure

CHAPTER 1. Introduction

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CHAPTER 1. INTRODUCTION

It is widely acknowledged that the indoor environment is important to public health and that a high level of protection against adverse effects resulting from inadequate Indoor Air Quality (IAQ) should be assured (WHO, 1999). In this context, European air quality policies should focus on indoor exposures to identify, control and eliminate indoor sources of pollution, in order to reduce important health risks associated with indoor air pollution, i.e. allergic and asthma symptoms, lung cancer, chronic obstructive pulmonary disease, airborne respiratory infections, cardiovascular morbidity and mortality, odour and irritation (Sick Building Syndrome symptoms). Consumer products consist one of the main indoor air pollution sources, together with outdoor air, building materials/equipment/ventilation and occupant activities (Oliveira Fernandes et al., 2008). Therefore, health risk reduction strategies associated with the use of consumer products indoors are required in case of hazardous emissions in order to protect and promote health in the indoor environment. However, the coherent development of strategies to reduce risk in the indoor environment is considered a challenge due to the complexity of indoor pollution sources, the effects pathways and the multitude of parties responsible for generating and respectively controlling indoor air pollution. To be effective, policies aiming at improving IAQ need to be part of a comprehensive, internally and externally consistent management strategy involving governments, institutions, professional bodies and individuals (Oliveira Fernandes et al., 2008). The initial step in the development of a risk reduction strategy is the risk assessment of the substance. The outcome of the risk characterization step of the risk assessment procedure is the conclusion either that the use of the substance can be considered to be of no immediate concern or that recommendations for risk reduction are necessary. In the framework of EPHECT, health risk assessment is performed in relation to key and emerging indoor air pollutants emitted during the household use of selected consumer products, and is reported under Work Package 7 (WP7, Deliverable 8). Health risk assessment can contribute to the development of specific recommendations for control, mitigation and/or remediation, or more general policy recommendations for improving IAQ through identified management options. Risk management for IAQ can involve regulatory strategies, such as bans of chemicals or products, emissions limits, labelling requirements, exposure limits and ventilation standards. Alternatively, non-regulatory approaches can be implicated, including the production of guidelines and guidance, labelling schemes, market and fiscal incentives, population information campaigns, training and education of involved parties, and support of sustainable non-polluting technologies (Oliveira Fernandes et al., 2008). While risk assessment is a science-based exercise, risk management involves also technical, economic, social and legal realities, as well as need for actions in case of incomplete information (Kotzias et al., 2005). Concerning emissions from consumer products, the “INDEX report” (Kotzias et al., 2005) and the “ENVIE co-ordination action” (Oliveira Fernandes et al., 2008) are the two major European projects that have dealt with the recommendation of risk reduction options associated with the use of consumer products indoors. Currently, under the REACH Regulation (European Commission, 2006), Risk Reduction Measures (RMMs) for consumer products are explicitly required to be documented, aiming at controlling, limiting or avoiding exposures, and helping to insure the safe use (or handling) of a substance as part of a consumer product. As a general remark, it has to be highlighted that REACH, as well as the rest of the policies in the existing EU legislation related to chemicals and consumer products - General Product Safety Directive 2001/95/EC (GPSD), Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging (CLP), Biocidal Products Directive 98/8/EC (BPD), Toys Safety Directive 2009/48/EC, Cosmetics Directive 76/768/EC – are mostly

CHAPTER 1 Introduction

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based on the product’s chemical content rather than on its emission patterns in order to specify safety conditions and limits. In the framework of EPHECT, recommendations for risk reduction options, along with a health risk assessment framework, are proposed, focusing on emissions from consumer products associated to their household use. These proposals should be further developed together with policy makers and relevant industrial associations in order to enhance the existing knowledge and to accomplish the implementation of product policies and related risk reduction options in a more informed and scientifically-supported way. The scope of this report is to form an overview of the health risk reduction options related to the emissions from consumer products currently available in Europe. This overview can be consulted in the framework of EPHECT for the selection of measures to reduce risk attributed to hazardous emissions from consumer products. This aim can be reached, either directly using the existing options, or indirectly using this document as a basis for the development of new ones.

CHAPTER 2. Developing strategies for risk reduction

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CHAPTER 2. DEVELOPING STRATEGIES FOR RISK REDUCTION

The term “risk reduction” refers to the act of taking measures to protect man and/or the environment from the risks identified (Van Leeuwen et al., 1996). “Risk reduction measures” are defined by experts as “any action, use of tool, change of parameter state or abatement of substance emission that is introduced during manufacture or use of a substance (either in pure state, in a mixture or included in an article) in order to prevent, control or limit or reduce exposure of humans and/or the environment” (RIP 3.2-2-IV WP 2 Task Group 2, 2007). The starting point for the development of a risk reduction strategy is to conduct a risk assessment of the chemical substance of concern. If the risk assessment concludes that there is a need for limiting the risks and that risk reduction measures are necessary in relation to one or more adverse effects, the development of a risk reduction strategy becomes a necessity. The risk assessment identifies the magnitude and character of the risks foreseen for a substance, derived from: - any significant hazardous effects and any significant routes of exposure; - the severity, reversibility and imminence of any critical effects; - the likelihood of specified effects occurring; and - the populations at risk. According to the guidance document “Development of Risk Reduction Strategies for Priority Chemicals” (IPCS, 1999), developing a risk reduction strategy is a generic step-wise process comprising of the following six basic steps: (i) Assessing potential risks Objective: Identify which specific stages in the manufacture, storage, distribution, use or disposal of the substance give rise to risks which need to be limited. (ii) Identifying risk reduction options Objective: Taking account of any existing risk reduction measures, identify a wide range of available options for reducing the risks which need to be limited. (iii) Identifying possible tools for implementing risk reduction Objective: Identify the administrative, legal and/or other tools with which any recommended action could be taken. (iv) Recommending the most appropriate approach Objective: Select the most appropriate risk reduction strategy by evaluating the list of potential effective measures and implementation methods against the following criteria: effectiveness, practicality, economic impact and monitorability. (v) Analyzing advantages and drawbacks if marketing and use restrictions are under consideration Objective: If marketing and use restrictions are recommended, draw up an analysis of the advantages and drawbacks as well as availability of alternatives. (vi) Drawing up a formal risk reduction strategy Objective: Submit the risk assessment and any recommended risk reduction strategy to decision makers.

CHAPTER 3. Existing EU risk reduction options

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CHAPTER 3. EXISTING EU RISK REDUCTION OPTIONS

3.1 The INDEX approach

The EC INDEX project (2002-2005) “Critical Appraisal of the Setting and Implementation of Indoor Exposure Limits in the EU” (Kotzias et al., 2005), funded by DG SANCO and coordinated by the European Commission’s Joint Research Centre/Institute for Health and Consumer Protection, evaluated the indoor air chemicals for which exposure and health data were available in Europe. The scope of the project was to identify priorities and to assess the needs for a Community strategy and action plan in the area of indoor air pollution. This scope was accomplished by setting up a list of compounds to be regulated in indoor environments with priority on the basis of health impact criteria, by providing suggestions and recommendations on potential exposure limits for these compounds, and by providing information on links with existing knowledge, ongoing studies and legislation at world scale. On the basis of the available information and after careful examination of the existing data, it was decided to conduct a detailed assessment of 14 out of initial 41 candidate compounds. These 14 compounds were categorized into three groups: the high priority chemicals (formaldehyde, carbon monoxide, nitrogen dioxide, benzene and naphthalene), the second priority chemicals (acetaldehyde, toluene, meta-, para-, ortho- xylene and styrene) and the additional chemicals of interest (α-pinene, d-limonene and ammonia). The outcome of the INDEX project was the formulation of recommendations of indoor air quality policies and management options for the high priority compound list of chemicals, i.e. the chemicals with potential of high indoor concentrations, recognized health impacts and effective risk management requirements. The second priority chemicals were not considered to urgently require regulatory risk management actions specifically in indoor air. Finally, the additional chemicals of interest for indoor air risk management were considered to need further research with regard to human exposure or dose-response before recommendations could be made. Among the risk management tools proposed in the INDEX project, the ones related to consumer product emissions are the following: (i) IAQ guidelines: Guideline values for key pollutants are useful when matching potential sources, occupant needs and ventilation rates. (ii) Ventilation standards can be powerful means of preventing or controlling indoor sources and ensuring sufficient contaminant dilution. (iii) Limits, labelling and reporting of the contents of or releases from consumer products can be quite inflexible and heavy instruments when mandated by law, but flexible and effective on voluntary basis, as long as commonly agreed (between consumers, builders, industry and public health authorities), widely published and generally understood criteria are used. A combination of both legal and voluntary actions is needed. Significant health hazards call for legal requirements; comfort and quality considerations are better managed by voluntary actions. Legal or voluntary, the labelling and product information schemes should be coordinated at European level. (iv) Public awareness raising and information is the key to safe indoor environments, because, due to their sheer numbers, a great majority of potential indoor pollution risks must be identified, assessed and managed by occupants themselves. They are best helped by widespread and general awareness raising information, and easily found and understood sources (leaflets, internet sites) for more specific technical information. Additionally to the general risk management tools mentioned above, specific management options were suggested for the high priority chemicals identified in the INDEX project. Among them, the ones suggested for formaldehyde, benzene and naphthalene are of interest for EPHECT and are listed below:

CHAPTER 3. Existing EU risk reduction options reduction

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Formaldehyde - Minimise emissions of formaldehyde from products. - Discourage the use of formaldehyde-containing products. - Require product labelling to inform about formaldehyde content and potential formaldehyde release

from household products. Benzene - Ban benzene sources indoors. - Lower the permissible benzene content in any consumer product and report about known benzene

levels also when below permissible levels. Naphthalene - Restrict the use of naphthalene-containing household products, particularly mothballs.

3.2 The ENVIE approach

The EC project ENVIE (Oliveira Fernandes et al., 2008) was a “European co-ordination action on Indoor Air Quality and Health Effects” (2004-2008), funded by DG Research in the context of the 6th Framework Research Programme (2002-2006). ENVIE focused on those indoor air quality issues of the highest Europe-wide health relevance. Its aim was to identify and evaluate the key building and housing-related policies, both existing and new, in order to improve IAQ in Europe and minimize the associated adverse health consequences. In the framework of this project, the health conditions which in Europe appear to have the strongest link to IAQ were initially identified. Then, the indoor air contaminants considered as the most likely causal agents for these health effects were assessed and the sources considered as the most likely contributors to these exposures were evaluated. ENVIE is related to consumer product emissions studied in EPHECT, both in terms of its “shortlist of exposures”, i.e. VOCs, combustion products, bio-aerosols, pathogens, radon, carbon monoxide, and its “shortlist of sources”, i.e. outdoor air, building materials/equipment/ventilation, consumer products and occupant activities. Among the main controls stated in ENVIE for the reduction or elimination of indoor-related health risks, the ones that are of interest to EPHECT can be found under the section “Consumer products, occupant behavior and maintenance” and include: (i) restrictions on the content of products, (ii) advice on the proper and safe use of products, and (iii) provision of adequate ventilation to prevent the build-up of hazardous concentrations of pollutants. The main conclusion of the ENVIE co-ordination action was the prioritization of the two main strategies for risk reduction, i.e. “source control” where the nature or strength of the sources, or even their existence indoors is removed, replaced or moderated, and “exposure control”, essentially through ventilation. In the ENVIE approach, the need to promote the first strategy was stressed, following the precautionary principle, according to which prevention is better than restitution, mitigation and restoration. More specifically, considering the targets for intervention, the elimination of the source of contamination, by removing or replacing or moderating it, was considered the option of first priority. Cutting or restricting the pathway from the source to the human indoor microenvironment by filtering the contaminant originating from the outdoor source(s) in the ventilation system or by extracting the effluents from indoor sources away from human exposure was considered the option of second priority. Another way considered to control exposure was the restriction of the time spent in a particular contaminated space and, as the ultimate solution, the


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dilution with increased ventilation. The levels of ventilation tend to decrease as a consequence of the “source control” strategies. The outcome of the ENVIE co-ordination action was the proposal of a framework to manage the issue of IAQ from the policy point of view. Among the various recommendations suggested, the ones of interest to EPHECT concerning consumer products lie under the recommendations on “policies concerning energy efficiency, building materials, products and maintenance”. In particular, the proposal regarded the development and application of European harmonized protocols for IAQ testing, reporting and labelling (common IAQ monitoring procedures). An agreement on a European harmonized protocol for the measurement, assessment and reporting of emissions from the use of cleaning and other household chemicals and products would be essential to ensure the high quality and healthiness of the products used, as well as the information to manage a high and predictable IAQ. According to ENVIE, for an evidence-based policy development, the following are required: (i) development of guidelines and procedures to measure emissions from consumer products, including criteria for low emitting products, (ii) development of a labelling system to control emissions from consumer products, and (iii) definition of standard methods for testing emissions from consumer products, similar to those developed for building materials and furnishings within the European standards organization (CEN), to provide comparable data on the release of chemicals and gases during their use. Additionally, the recommendation on the development of European health-based ventilation guidelines to control exposure to pollutants from indoor and outdoor sources, lying under “policies concerning specific building constructions and equipment” can be mentioned.


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3.3 The REACH approach

Under the European chemicals legislation, REACH Regulation (EC) No 1907/2006, in order to ensure efficient risk management of industrial chemicals, an important objective is to encourage and in certain cases to ensure that substances of high concern are eventually replaced by less dangerous substances or technologies, where suitable economically and technically viable alternatives are available (European Commission, 2006, paragraph 12). For the regulation of the use of chemicals in consumer products, in particular, REACH uses both “criteria-based” and “substance-specific” processes. The first approach defines a set of criteria that need to be applied in order to identify substances that are eligible for regulation, while the second one regulates particular identified substances that are listed in the legislation (Molander and Ruden, 2012). REACH requires assessing exposure resulting from all conditions of use, i.e. Operational Conditions (OCs) and Risk Management Measures (RMMs), within an Exposure Scenario (ES). The resultant exposure estimate should then be compared with the Derived No Effect Level - DNEL for the critical endpoint in order to demonstrate control of risks. Among actors across supply chains, REACH establishes a duty for information exchange on the foreseeable uses and risks relative to the substances in consumer products, including the OCs and RMMs that are necessary for the safe use of a substance. For the different foreseeable uses of consumer products, including normal use, misuse, and accidental use, posing different risks, use-specific ESs and OCs/RMMs need to be considered as part of the risk assessment; they are explicitly required to be documented as part of the Chemical Safety Report and they are communicated down the supply chain via the Safety Data Sheet (Bruinen de Bruin et al., 2007). Under REACH, there are two basic types of RMMs related to exposure to consumer products (ECHA, 2012): (i) the “product-integrated” RMMs, under the control of the supplier, and (ii) the “consumer instruction/communication on safe use” RMMs. The first type of RMMs addresses technical measures that are developed during the design phase and applied during the manufacturing, assembling and finishing operations of a product before its use by consumers. These RMMs should cover to a high extent the foreseeable identified uses by the consumers and the related risks. The second type of RMMs includes labelling and refers mostly to the product-related risk and safety instructions, communication and education directed at the product users. As the effectiveness or real application of this type of RMMs depends on the willingness of the actual user to follow them, these are difficult to control by the product manufacturer, importer or distributors (Bruinen de Bruin et al., 2007). As presented in the “Guidance on information requirements and chemical safety assessment document” (ECHA, 2012), where the study of Bruinen de Bruin et al. (2007) is consulted, the two aforementioned types of consumer product RMMs can be further sub-divided into the categories shown in Figure 1.


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Figure 1: Product-integrated and consumer instruction/communication RMMs that can be considered in the ES (ECHA, 2012).

Under REACH, to enable efficient information exchange on RMMs among the actors across supply chains, the RMM library (available via http://www.cefic.org) serves as a tool to collect, store, and select appropriate information on RMMs (occupational, consumer and environmental). This library was developed in the context of the preparation of the ECHA Guidance on Chemical Safety Assessment with the aim to provide information to specify RMMs chosen to eliminate or minimize exposure to hazardous substances. The RMM library is built upon generic RMMs standard descriptors (name, description, reference for the different types of RMMs), descriptive fields for specific RMMs applications and RMMs efficiency calculation fields. Considering that OCs, i.e. use conditions such as duration/frequency of exposure and applied amount of chemical, may also be used to reduce or eliminate risks of exposure, these are listed together with the RMMs in the library. All RMMs/OCs are allocated in “RMM/OC Categories”, which are further sub-divided into different types - referred to as “RMM/OC General Names (Types)”. Under the “RMM/OC General Names (Types)” headings, names of particular measures can be found as “RMM/OC Specific Names” with a corresponding “RMM/OC Description” to further define the measure and ensure that there is common interpretation and understanding. In addition to the above, each RMM/OC is assigned a “Unique Number”, i.e. a reference number. Under REACH, RMMs/OCs are implemented in order to reduce human exposure to hazardous compounds. Among all RMMs/OCs described in the RMM library, the ones (RMM/OC specific names) relevant to exposure to consumer products - by inhalation only - are indicated below, listed under the corresponding categories (in bullet points) and general names/types (in italics). It has to be noted that the measures of elimination and substitution of a substance are not included in the library; these cannot be considered as


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RMMs to be reflected in an ES as the registrant will not provide an ES for uses in which the substance is substituted (ECHA, 2012).

“Product-substance related” Limiting concentration of hazardous or non-hazardous ingredient - Reduce hazardous ingredients in product so no longer classified as dangerous - Control of pH - Control of inhalable and/or respirable particulates/aerosols - Control of reactivity - Dilution by user prior to application Change of physical state (e.g. powder pellet) - Control of physical form (to prevent or reduce inhalation, e.g. tablets or paste vs. powder or aerosol,

inclusion in matrices) - Control of solubility User friendly packaging (reducing handling) - Packaging of the product (to allow delivery of product with minimal inhalation exposure) - Packaging - type of closure (e.g. child-resistant caps) - Packaging - orifice size (to control dispensing of product) - Packaging - size (to minimize exposure to user during normal usage or from accident if entire contents

are spilled, to make product too big for children to handle, to limit the volume of packets, dozers) - Packaging - pre-dosed one way (product already mixed for use) Info / Guidance / Manual other than label and safety data sheet - First aid instructions (for treatment of accidental exposures) - Technical data sheet/instructions for use - Advice on maximum time for product/substance handling use

Marketing and use related Marketing and use – general - Control of aesthetics (e.g. colour or fragrance, to minimize confusion or attractiveness to children) Product safety /advice - Avoid exposure - obtain special instructions before use - Do not breathe dust - Do not breathe gas/fumes/vapour/spray - Do not empty into drains, dispose of this material and its container at hazardous or special waste

collection point - Do not empty into drains - Do not mix with ... (to be specified by the manufacturer) - Handle and open container with care - During fumigation/spraying wear suitable respiratory equipment - Never add water to this product - Not recommended for interior use on large surface areas


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- Usage instruction - storage - Advice against misuse of product (e.g. (i) do not use for …. (ii) do not mix with ... (iii) keep away from…

e.g. heat) - Keep at temperature not exceeding ...°C - Keep away from ... (incompatible materials to be indicated by the manufacturer) - Keep away from combustible material - Keep away from heat - Keep away from sources of ignition - no smoking - Keep container in a well-ventilated place - Keep container tightly closed and at temperature not exceeding ... °C - Keep container tightly closed and in a well-ventilated place - Keep container tightly closed in a cool place - Keep container tightly closed in a cool, well-ventilated place (obsolete) - Keep container tightly closed - Keep in a cool place away from ... (incompatible materials to be indicated by the manufacturer) - Keep in a cool place - Keep in a cool, well-ventilated place away from ... (incompatible materials to be indicated by the

manufacturer) - Keep only in the original container at temperature not exceeding ... °C - Keep only in the original container in a cool, well-ventilated place - Keep only in the original container in a cool, well-ventilated place away from ... (incompatible materials

to be indicated by the manufacturer) - Keep only in the original container - Keep out of the reach of children - Keep wet with ... (appropriate material to be specified by the manufacturer)

Process control /change Process control /change - Supply in pre-dosed, disposable packaging (to eliminate portioning and weighing) - Limitation of quantity used/applied per time unit (exposure proportional to quantity handled if nothing

else is changed while duration is equal) - Limitation of duration of heat producing or dispersive process (e.g. homogenization, to reduce change of

temperature that would lead to emission or to reduce amount dispersed) - Specified minimal room size for application (room size assumption for worst case conditions in case of

presence near source of dispersion) - Specified minimal room height for application (border assumption for considering dilution by

convection) - Wetting of material with water to limit dust emission or explosion (binds fines that would otherwise be

swirled up and may form explosive atmosphere or exposure) Cleaning of process equipment - Washing/rinsing items with water/detergent following manufacturing process (for water insoluble

components - applies to washing of product/item before use and is relevant e.g. for consumers using textiles)

- Washing/rinsing items with water (per se or following cleaning with detergent) (for water soluble components and complementary to cleaning with detergent - applies to washing of product/item before use or further processing after surface treatment and is relevant for consumers using textiles)


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Reduction of waste, disposal of waste - Disposal - Dispose of this material and its container at hazardous or special waste collection point

(collection system for hazardous waste e.g. supplier return systems)

General dilution ventilation Dilution ventilation - Open windows - Use only in well ventilated areas

Personal protective equipment Respiratory protection - Use dust or gas filter mask Face/eye/ear protection - Wear eye/face protection - Goggles - Chemical resistant (tight goggles to avoid contact of eyes with gases)

First aid measures First aid measures - In case of accident by inhalation: remove casualty to fresh air and keep at rest

CHAPTER 4. The EPHECT contribution

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CHAPTER 4. THE EPHECT CONTRIBUTION

The wide range of policies related to chemicals and consumer products in the existing EU legislation – REACH, GPSD, CLP, BPD, Toys Safety Directive, Cosmetics Directive – are not fully harmonized. This fact makes a robust and collective risk assessment of chemicals difficult to be achieved. Broader guidelines on IAQ at European level would be the preferred option as an umbrella of policy. Yet, in practice, however, their implementation for consumer products in private dwellings would not be easy. All current EU policies related to chemicals and consumer products specify safety conditions and limits mostly based on the product’s chemical content rather than on its emission patterns. In the framework of EPHECT, the need to focus on consumer product emissions for the recommendations of risk reduction options, as well as for the proposal of a health risk assessment methodology, is stressed. More specifically, it is suggested that testing methodologies for the emission measurements should be harmonized at EU level so that quality data are collected and a robust risk assessment associated to the use of consumer products indoors is achieved. Furthermore, the testing methods should represent the intended use and application of the product, in a context of harmonised scenarios for the different product classes. The outcome of EPHECT should be considered as pre-normative work, able to provide advice and recommendations on future standardisation of consumer products emission testing, considering the gaps identified. It can directly be beneficial to the work of the European Committee for Standardization (CEN) on consumer products, extend the recently developed CEN TC 351 horizontal standard on construction products, as well as the recently set-up CEN Project Committee (‘PC 421’) on ‘Emission safety of combustible air fresheners and similar products’. In the current setting, where EU legislation mainly limits the contents of pollutants and EU actions establish priorities on strategies to reduce their concentrations in spaces, product labelling would be the connection between concentrations and emissions, as a means of source control. According to the Preparatory EU working expert group (ECA WG 27) coordinated by the European Commission’s Joint Research Centre (EC-JRC), the development of a harmonized labelling system at EU level to control emissions from consumer products is recommended. This harmonized framework for indoor product emissions labeling schemes should comprise core and transitional criteria for the chemical characterization and the sensory and health evaluation of product emissions (ECA report No. 27, 2012). At EU level, there are no practices regarding harmonised labelling for consumer products, yet. The health risk assessment of chemicals emitted from consumer products in the framework of EPHECT could form a basis to extend the recently developed EU-LCI harmonisation framework (ECA report No. 29, 2013; in press); the latter framework focuses on the evaluation of chemicals emitted from construction products from a health stand-point, based on the LCI (Lowest Concentration of Interest) concept, and could be extended to chemicals emitted from various consumer products, where applicable.

CHAPTER 5. Conclusions

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CHAPTER 5. CONCLUSIONS In the context of reducing risk associated to the indoor use of consumer products in Europe, EPHECT can contribute to the development of efficient risk management guidance and formulation of policy options. This objective can be reached by evaluating the outcome of a human health risk assessment of priority compounds emitted during the household use of selected consumer products conducted in the framework of the project. The main purpose of this document is to provide an overview of the health risk reduction options available in Europe related to the emissions from consumer products. These management options have been mainly developed in the frame of the INDEX project (Kotzias et al., 2005), the ENVIE co-ordination action (Oliveira Fernandes et al., 2008) and the REACH Regulation (EC) No 1907/2006 (European Commission, 2006). In the framework of EPHECT, according to the conclusion of risk characterization for each of the consumer products selected, this synopsis can be consulted to select measures for risk reduction in case emissions are considered hazardous. The existing options can either be implemented directly or used as a basis for the development of new ones to promote health in the indoor environment. In EPHECT, the ENVIE concept is followed concerning the prioritization of strategies for optimal IAQ, that is from “source control” to “exposure control”. “Source control” is given first priority, according to the precautionary principle, in order to avoid, moderate or manage the indoor sources of emissions. “Exposure control”, achieved mostly through ventilation to ensure sufficient contaminant dilution, should be seen as a subsequent resort when deciding on control measures. The main options currently available in Europe aiming towards an efficient reduction of risk associated with emissions from consumer products include: - elimination and substitution of hazardous compounds - limitation of the concentration of hazardous compounds - reduction of emissions of hazardous compounds - change of physical state of a product - adequate product packaging of a product which reduces handling - limitation or restriction of the use of a product - product labelling regarding the content of hazardous compounds and their potential release from

consumer products - instructions, information and warnings regarding normal/safe use of a product (duration, frequency,

quantity) - adequate ventilation to prevent the build-up of hazardous concentrations of pollutants - use of personal protective equipment. In general, measures related to consumer instructions regarding the safe use of products are considered difficult to control, as adherence to instructions as risk management measures cannot be guaranteed. For example, consumers will not necessarily use Personal Protective Equipment (PPE) even when recommended by the manufacturer and/or when PPE is provided with the product. Additionally, the actual application of adequate ventilation is usually difficult to achieve in practice and certain ventilation rates cannot always be assured. Therefore, under REACH, the implementation of “product-integrated” RMMs, under the control of the supplier is a preferred choice over “consumer instruction/communication on safe use” RMMs for an efficient reduction of risk. Currently, EU legislation related to chemicals and consumer products specifies safety conditions and limits mostly based on the product’s chemical content rather than on its emission patterns. In the framework of EPHECT, the need to focus on consumer product emissions in order to propose risk reduction options, as well as to suggest a methodology for health risk assessment, is recommended. These proposals should be further developed together with policy makers and industry so that existing knowledge is enhanced and the

CHAPTER 5. Conclusions

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implementation of policies and risk reduction options related to the chemical emissions from consumer products is achieved in an efficient and science-oriented way. Last but not least, a harmonisation framework at EU level for emission testing methodologies, health-based evaluation and product labelling criteria would be an efficient way forward.

References

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