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Indoor air quality and its effects on health: the case of consumer products. EPHECT project Final Event at the EP 18th of September 2013 17:30 – 21:00 Room ASP 3H1

Chaired by Mrs. Catherine Stihler / Mr. Claude Moraes MEP

The EPHECT project (Emissions, exposure patterns and health effects of consumer products in the EU) focuses

on exposures resulting from the household use of personal care products, air fresheners, and cleaning agents.

More specifically, products causing an exposure that is related to the use scenarios, and products being

potential sources of health relevant air pollutants in households, were selected for a more thorough analysis in

this project. Emphasis was put on EPHECT key and emerging indoor air pollutants that were selected with

respect to international concerted actions or organisations (WHO, Index, etc.) and existing guidelines or limit

values. The EPHECT key pollutants include: CO, NO2, ammonia, benzene, toluene, xylenes, styrene, phthalates,

lead, O3, PAHs, naphthalene, PCBs, PCDDs, chloroamines, hypochlorite, H2O2, formaldehyde, acrolein,

glutaraldehyde, acetaldehyde, siloxanes, fluorinated, quaternary ammonium chlorides -Ozone-consuming

compounds: limonene, α-pinene, geraniol, a-terpineol, linalool -Specific airway allergens: isocyanates, acid

anhydrides, radical production - particles (fine & ultrafine): ultrafine PM < 0.1, particle number, size fraction

area, chemical characterisation, metals, carbon (EC/OC), and oxidized PAHs. This list was applied to determine

the compounds that were feasible to assess in product emission testing.

The study was initiated by a literature

review, inventorying published and

accessible emission and exposure

data of any consumer product. This

information was the starting point for

the development of BUMAC, the

database on emissions and exposures

related to consumer products. Using

pre-established verification criteria,

15 relevant product classes of

personal care products, air

fresheners, and cleaning agents were

identified for further research in

EPHECT. These include: all purpose cleaners, kitchen cleaning agents, floor cleaning agents, glass and window

cleaners, bathroom cleaning agents, furniture polish, floor polish, coating products, combustible air fresheners,

air freshener sprays, passive air fresheners, electric units, hair styling sprays, deodorant sprays and perfumes.

In order to develop a suitable product emission test protocol as well as a representative exposure assessment,

a market study on product uses, involving 4335 respondents from 10 different EU member states, was

organized. Consumption information and use scenarios in North, South, East and West Europe were

Outcome of the EPHECT market study on the EU uses and use patterns of

consumer products

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inventoried, which lead to the identification of relevant characteristics and parameters for emission testing and

exposure assessment. Most used brands, regional use scenario differences as well as typical use habits such as

respecting user guidelines, excessive uses of a product, and room ventilation during or after the product

application, were assessed.

The EPHECT umbrella for consumer product testing was developed in order to establish an EPHECT emission

test scenario, characterised by a maximum agreement with the existing standard for building materials, as well

as a maximum similarity between the protocols for the different studied product classes. According to the

EPHECT umbrella, the product test scenario is determined by (1) the product’s aggregation state (liquid, gel,

solid), and (2) product package, which is on its turn related to the use scenario (to be sprayed, to be volatilized,

to be applied with a cloth, etc.). Experiments were performed by 4 laboratories, each utilising an emission test

chamber of different dimensions. A suitable QA/QC strategy was designed, involving any analysis performed by

the laboratories. For the majority of the product classes, two products (including the EU most used product

brand) were subjected to product emission testing. In total 25 different products have been tested.

Additionally, for one personal care product, one air freshener and one cleaning agent, the EPHECT test scenario

was applied on the same product in all 4 laboratories, by a different operator, in an emission test chamber of

different dimensions. The results of this inter-laboratory study indicated that the most straight forward test

scenario (e.g. one spray on a cotton cloth), lead to the most reproducible normalized specific emission rates.

Other use scenarios such as applying the product and spreading it over a surface, using a cloth, indicated a

more complex reproducibility between the laboratories. The experiments also emphasized the importance of a

suitable loading factor. For all tested products, normalized specific emission rates of (respiratory health

related) EPHECT priority compounds were calculated based on test chamber concentrations.

EPHECT Umbrella for consumer product emission testing

A more thorough screening of all emitted VOCs (volatile organic compounds) as well as the assessment of the

emitted TVOC levels (total volatile organic compounds C6-C16, according to ISO 16000-6) underlined the

importance of further research on compounds that have not been prioritised in EPHECT. It was noticed that the

majority of the tested continuous emission sources (excluding candles) lead to ideal room concentrations that

are situated in the recommended Evaluation Standard Level 1 (0.3 -1 mg/m³) of the German IRK/AOLG Ad-hoc

Working Group. Level 1 is described as ‘No relevant objections, provided that any guide values for individual

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substances or groups of substances are not exceeded’. TVOC levels of

discontinuous sources may be elevated as well; however, more

detailed indoor modelling is needed to assess the impact on the

indoor air.

The formation of secondary reaction products in presence of ozone

was studied for a kitchen cleaning agent, an electrical as well as a

passive air freshener. The selection of these product classes was

based upon the qualitative identification of compounds that are

known to easily undergo ozone-initiated reactions, i.e. terpenes, like

limonene, within the time-frame of typical indoor exchange rates.

Quantified secondary reaction products (in excess of ozone) include

formaldehyde and acetaldehyde, but also poly-oxygenates like IPOH

(3-Isopropenyl-6-oxo-heptanal), 6-MHO (6-methyl-5-heptene-2-one), 4-AMCH (4-Acetyl-1-methylcyclohexene

)and 4-OPA (4-oxo-pentanal), known to be typical key oxidation products of limonene (Atkinson and Arey,

2003; Calogirou et al., 1999). A tentative health risk assessment on respiratory effects of the quantified

secondary reaction products was based on recent human reference values (Wolkoff et al., 2013) and reported

Lowest-Observed-Adverse-Effect-Level (LOAEL) values for formaldehyde and acrolein. It showed that for the

certain terpene containing products, concern should be raised to both acute effects and sensory irritation (eyes

and upper airways), but also to airway limitation in the conducting airways. Acrolein reached close to 100% of

its proposed LOAEL value for long-term effects. Further research on reaction mechanisms, validations in real-

life, and exposures and risk assessment is therefore justified.

The reconsideration of the EPHECT priority compounds in the light of available literature as well as their

occurrence in the experimental product testing outcomes, lead to the identification of acrolein, formaldehyde,

naphthalene, d-limonene, and α-pinene as target pollutants for respiratory health risk assessment. Hazard

identification and dose-response relationship were assessed by evaluating human and animal toxicological data

concerning effects of short and long-term inhalation exposure. The critical effect, No-Observed-Adverse-Effect-

Level (NOAEL) and Lowest-Observed-Adverse-Effect-Level (LOAEL) were identified for each priority compound

and the limits of exposure in the framework of EPHECT were calculated. For the purposes of health risk

assessment, irritative and respiratory end-points were considered, both for acute exposures of 30 min,

reflecting exposure during use, as well as for long-term exposures of 24 h, reflecting the exposure during daily

activities.

Indoor air modelling was performed using specific emission rates derived from the experiments, respecting the

outcomes of the EPHECT market study. Exposure assessment was performed using the most representative

worst-case specific emission rate for every EPHECT target compound mentioned above, emitted during

household use of the selected consumer product classes, plus for the compound benzene. A methodology was

developed to construct scenarios for the use of consumer products by two population groups (housewives and

retired people) in the 4 geographical areas of Europe (North, West, South, East), based on the re-analysis of the

market study data (i.e. 8 population groups). Subsequently, the most representative worst-case scenario

regarding the product use in home micro-environments was identified, respecting the use preferences of the

population group in each geographical area. Representative ventilation rates for every geographical region,

used for indoor air modelling, were derived from literature. To be proactive, the situation at a theoretical ‘zero’

ventilation rate (of 0.1 ACH) was calculated as well. Indoor air modelling was performed on 3 levels of

complexity: Level 1: one product, one compound in one microenvironment (CONC-CPM, comparison with

BAMA model); Level 2: many products, one compound, exposure in one microenvironment (CONC-CPM model)

and Level 3: many products, all compounds (that can be modelled) in one dwelling, including thus several

microenvironments (IAQ chemical model with lumped chemical scheme). Because of its complexity as well as

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the indoor environmental parameters needed for the latter simulation, this level could only be accomplished

for the U.K.

For risk characterisation, the exposure assessment was related/compared to the health-based limits of

exposure. These consist of the WHO guideline values (for formaldehyde and naphthalene), and other health-

based limits of exposure determined in EPHECT (for acrolein, d-limonene and α-pinene). The indoor air

concentrations in each microenvironment of a compound from single product use were then expressed as a

percentage of the health-based limit of exposure, however, without considering the possibility of multiple

sources.

The results for the 30-minutes exposures as well as for the 24-h exposures showed that in all 25 tested

products, none of the 5 target pollutants of health risk assessment was exceeding their corresponding limit of

exposure. The highest contributions to the 30-minute exposures were found for formaldehyde (82% of its limit

of exposure) emitted from floor cleaning agent; for acrolein (4% of its limit of exposure) emitted from a candle;

for d-limonene (2% of its limit of exposure) emitted from a kitchen cleaning agent, and for α-pinene (0.04% of

its limit of exposure) emitted from floor cleaning agent. For 24-hours exposures, naphthalene emitted by

furniture polish emitted about 15% of its limit of exposure, formaldehyde emitted by floor cleaning agent

reached about 8% of its limit of exposure, acrolein emitted from a candle reached 2% of its limit of exposure, d-

limonene emitted from a kitchen cleaning agent also 2% of its limit of exposure and α-pinene emitted from a

passive air freshener reached 0.2% of its limit of exposure. In the set of EPHECT consumer products, benzene

was found to only be emitted from candles. Data analysis on aggregated exposures (several products, exposure

to one compound in one or several micro-environments) showed that also exposures resulting from the use of

different products were below the limits of exposures both for long- as well as for short-term exposures,

although considerable contributions to short-term exposures may be obtained at low ventilation conditions. It

should be noted that exposure modelling and health risk assessment in EPHECT is focussed on the 5 target

compounds; it does not take into account other pollutants, TVOC or secondary reaction products. It is however

the first study in its kind to provide exposure estimates and health risk assessment for 8 population groups

across Europe (respecting regional differences in uses and use scenarios as well as ventilation conditions of

each region and population group), using 15 different consumer product classes in households.

Final recommendations, resulting from EPHECT have been focussed to risk management for consumer

products, recommendations for policy makers, and recommendations for users. Risk management for

consumer products emphasizes the importance of the definition of a consumer, as distinctions should be made

between intended and non-intended users, and between vulnerable and less vulnerable users. The use and use

scenario of a product, such as frequency, duration, combinations with other products and building materials,

ventilation and expected use, will also affect the total exposure, thus the risk of the consumer. In fact, the EC

project ENVIE (Oliveira Fernandes et al., 2008) “European co-ordination action on Indoor Air Quality and Health

Effects” (2004-2008), presented a main conclusion with relevance in this context: 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.

This option is however in the hands of the manufacturers and policy makers that can force to decrease the

contaminants present in the consumer products. Another way considered to control exposure was the

restriction of the time spent in a particular contaminated space and, as the ultimate solution, the dilution with

increased ventilation, which can be implemented by the consumer.

In the review of policies, it was verified that most of existing EU policies on chemicals and consumer products

(e.g. REACH, General Product Safety Directive, CLP/GHS, Biocidal Products Directive, Toys Safety Directive,

Cosmetics Directive, etc.) specify safety conditions and limits mostly based on chemical content and not on

emissions patterns. The EPHECT’s guidance for emission testing umbrella protocol for various categories of

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consumer products as well as the results obtained for emission should be seen as a pre-normative work, which

will provide advice and recommendations on future standardisation of emission testing of consumer products

along with gaps identified and needs for further research. At this stage, it is not possible to propose

recommendations on limits of contaminants based on the results of the Project. But it is however possible to

propose recommendations on the strategies used to develop new guidelines. In the last year of the project an

EPHECT Stakeholder Meeting took place in Brussels, on May 15th

, in order to present the results of the project

to stakeholders, and to hear their opinions in what regards actions are to be taken. After a short discussion, a

set of main conclusions could be retained. It was clear that all participants identified the need of well defined

procedures and a clear message from policies. In general, some words were common for all represented

stakeholders: Harmonization and Simplification.

Regulation is the most powerful tool to force people to create a good indoor air quality (Bluyssen, 2010). For

Consumer Products, at this stage there is still research work required in order to provide further foundations

for preparing objective regulation. EPHECT created and demonstrated the building blocks for a health related

consumer product evaluation. However, Policy Makers should provide the actors with the instruments

necessary to apply and increase this knowledge. It is essential to further support research and technical work,

as CEN in the areas of Methods of Testing, and Risk Assessment.

All documents will be available from the 1st

of October 2013 on www.ephect.eu

EPHECT Associated Partners

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.

Air Quality Measurements, Environmental Risk and Health, VITO

Eddy Goelen,Marianne Stranger, Jeroen Van Deun, Frederick Maes

Eurofins (DK, G) Reinhard Oppl

Department of Engineering and Management of Energy Resources, University of West Macedonia, UOWM

John Bartzis, Evalgelis TolisSani Dimitroupoulous

Institute for Health and Consumer ProtectionCEC-JRC (I)

Stylianos KephalopoulosJosefa Barrero-Moreno

Methods, Research and External Relations, ANSESSandrine Fraize-Frontier;Derrick Crump (Cranfield University, subcontractor)

Umwelt Bundes Amt, UBA (G) Christine Daumling

Chemical-Technical Analysis and Chemical Food Technology, Technische Universität München, TUM

Albrecht FriessThomas Letzel

Health Food Safety and Environment, FPS(B)

Robert MartensFabrice Thielen

Indoor Environment Group, National Research Centre for the Working Environment, NRCWE

Peder WolkoffAsger Nörgard

European Chemical Industry Council, CEFIC Loredana GuineaManfred Giersig

Unit of Advanced Studies on Energy in the Built Environment, Instituto de Engenharia Mecânica, IDMEC

Eduardo de Oliveira Fernandes, Gabriela Ventura Silva

TUM Business School (G)Larissa DrescherJutta Roosen

Dipartimento di Medicina del Lavoro, Università degli Studi di Milano, UMIL

Paolo CarrerMarilena Trantallidi

International Association for Soaps, Detergents and Maintenance Products, AISE

Gerard Stijntjes Paul Loyd

IPSOS BelgiumAndrew JohnsonElena Lucica

Associated partners