Scientific Opinion
Scientific Opinion
Brominated flame retardants
Brominated flame retardants (BFRs) are mixtures of man-made chemicals that are added to a wide variety of products, including for industrial use, to make them less flammable. They are used commonly in plastics, textiles and electrical/electronic equipment.
There are five main classes of BFRs, listed here with their common uses:
- Hexabromocyclododecanes (HBCDDs) – thermal insulation in the building industry.
- Polybrominated diphenyl ethers (PBDEs) – plastics, textiles, electronic castings, circuitry.
- Tetrabromobisphenol A (TBBPA) and other phenols – printed circuit boards, thermoplastics (mainly in TVs).
- Polybrominated biphenyls (PBBs) – consumer appliances, textiles, plastic foams.
- Other brominated flame retardants.
These classes have been marketed as technical mixtures under different commercial brands. In the European Union the use of certain BFRs is banned or restricted; however, due to their persistence Persistence refers to the ability of harmful organisms like bacteria to survive and thrive despite regular cleaning and disinfection efforts, potentially lingering in hidden places for months or even years. in the environment there are still concerns about the risks these chemicals pose to public health. BFR-treated products, whether in use or waste, leach BFRs into the environment and contaminate the air, soil and water. These contaminants may then enter the food chain where they mainly occur in food of animal origin, such as fish, meat, milk and derived products.
Latest
EFSA is updating its scientific opinions on BFRs in food, taking into account new occurrence The fact or frequency of something (e.g. a disease or deficiency in a population) happening. data and scientific information. The work is scheduled for completion by 2025.
EFSA experts are assessing the risks raised by each BFR class present in food individually, after which they will consider whether employing a mixture approach for all the assessed BFR classes is appropriate.
European and national decision-makers use EFSA’s scientific advice, together with other considerations, to decide on possible measures to reduce consumer exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. to contaminants in food. Such measures might include, for example, the setting of maximum levels in food.
The scientific opinions on the risks to human health related to the presence of hexabromocyclododecanes (HBCDDs) and of polybrominated diphenyl ethers (PBDEs) in food were updated in 2021 and 2024, respectively (see Milestones).
Experts are currently finalising their assessment of the risks to human health related to TBBPA and its derivatives, taking into consideration the comments received during a public consultation of the draft opinion. The publication of the scientific opinion is expected for July 2024.
The following draft scientific opinion is open for public consultation:
As a next step, experts will assess a set of emerging and novel BFRs.
Currently, there are restrictions in place for the production, sale and use of products containing PBDEs. In March 2023, ECHA released its regulatory strategy for flame retardants, emphasising the need to minimise the exposure to aromatic brominated flame retardants and identifying them as candidates for EU-wide restriction.
Milestones
2024
January 2024
EFSA publishes its updated opinion on polybrominated diphenyl ethers (PBDEs) in food. Experts conclude that current dietary exposure For the purposes of risk assessment, measurement of the amount of a substance consumed by a person or animal in their diet that is intentionally added or unintentionally present (e.g. a nutrient, additive or pesticide). to PBDEs in the European population Community of humans, animals or plants from the same species. is likely to raise a health concern. The most significant effects relate to the reproductive and nervous systems.
2021
March
EFSA publishes a scientific opinion on the risks to human health related to the presence of hexabromocyclododecanes (HBCDDs) in food. Experts conclude that current dietary exposure to HBCDDs across European countries does not raise a health concern. The only exception is breastfed infants consuming breast milk in high amounts and with high levels of HBCDDs. In this case EFSA concludes that the exposure may raise a health concern, noting that more data on the levels of HBCDDs in human milk are needed to enable a more robust exposure assessment One of the key steps in risk assessment, this relates to a thorough evaluation of who, or what, has been exposed to a hazard and a quantification of the amounts involved..
2012
October
The scientific opinion on emerging and novel BFRs looks at lesser-known BFRs not covered in the five other scientific opinions. Whereas emerging BFRs have been identified in materials and/or goods and in wildlife, food or humans, novel BFRs have been identified only in materials and/or goods but not in wildlife, food or humans. Limited and widely varying data on 17 emerging and 10 novel BFRs were collected. Due to the lack of data and limited information on occurrence, exposure and toxicity The potential of a substance to cause harm to a living organism. for all these BFRs, a risk characterisation The final stage of risk assessment, in which the likelihood that a particular substance will cause harm is calculated in the light of the nature of the hazard and the extent to which people, animals, plants and/or the environment are exposed to it. was not possible. Experts identified some emerging and novel BFRs that could be a potential health concern and should be considered first for future investigations.
April
EFSA publishes an opinion on Brominated phenols and their derivatives (other than TBBPA or its derivatives). Due to the lack of occurrence data and toxicity studies, the risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. focuses on 2,4,6-tribromophenol (2,4,6-TBP). It is unlikely that current dietary exposure to 2,4,6-TBP in the EU would raise a health concern. Also, exposure of infants to 2,4,6-TBP via breast feeding is unlikely to raise a health concern. Due to lack of data a risk assessment of the other brominated phenols or their derivatives was not possible.
2011
December
Current dietary exposure to Tetrabromobisphenol A (TBBPA) in the EU does not raise a health concern. No occurrence data for TBBPA derivatives were submitted to EFSA and no information on their toxicity was identified.
July
EFSA concludes that current dietary exposure to Hexabromocyclododecanes (HBCDDs) in the EU does not raise a health concern. Furthermore, additional exposure, particularly of young children, to HBCDDs from house dust is unlikely to raise a health concern.
May
EFSA considers eight polybrominated diphenyl ethers (PBDEs) of primary interest. Relevant toxicity data are available for four of them (BDE-47, -99, -153 and -209). The risk assessment is limited to these four, for which the margin of exposure (MOE) approach is used. For BDE-99, the MOE The margin of exposure (MOE) is a tool used in risk assessment to explore safety concerns arising from the presence of a potentially toxic substance in food or animal feed. indicates a potential health concern with respect to the current dietary exposure. This was notable for young children (aged 1-3 years old), although the presence of one food sample in the category ‘Food for infants and small children’ with a high concentration of BDE-99 could have led to overestimation of the exposure for this specific age group. For BDE-47, -153 and -209 the current dietary exposure is unlikely to raise a health concern.
2010
Since October
Between October 2010 and October 2012, EFSA’s Panel on Contaminants in the Food Chain (CONTAM Panel) completed a series of six scientific opinions on the main groups of BFRs and potential risks to public health from their presence in food.
EFSA experts conclude that the risk to the European population from exposure to Polybrominated biphenyls (PBBs) through food is of no concern.
2006
February
EFSA identifies some compounds to be monitored in food and feed, based on knowledge on the production volumes, the occurrence of each chemical compound in food and feed, their persistence in the environment and their toxicity. This follows a request from the European Commission to determine the chemical compounds within the groups of BFRs that may be a concern for human and/or animal health to monitor their possible presence in food and feed.
EFSA's role
EFSA provides scientific advice and risk assessments on BFRs for EU risk managers to help them assess the need for regulatory measures as regards the safety of BFR-contaminated food. EFSA is required to:
- Evaluate the toxicity of BFRs for humans considering all relevant toxicological information available.
- Carry out exposure assessments on the basis of occurrence data obtained in food monitoring activities, in particular, from EU Member States.
- Consider the exposure of specific population groups (e.g. infants and children, people following specific diets, etc.) to BFRs through food and indicate the relative importance of other non-dietary sources.
- Explore whether individual compounds can be used as markers for dietary exposure to BFRs.
- Identify potential data gaps for the five groups of BFRs.
EU framework
The EU has adopted legislation to reduce or halt the sale and use of certain BFRs to protect health and the environment.
In particular, in 2003 an EU directive prohibited the placing on the market of two commercial mixtures of PBDEs, known as PentaBDE and OctaBDE, as well as their use in preparations if they had more than 0.1% of these substances by weight.
Since 2006 new electrical and electronic equipment is not allowed to contain any amount of PBBs and PBDEs.
In July 2008, the European Court of Justice (ECJ) banned a third PBDE mixture, DecaBDE, originally exempted from the restrictions.
In 2014, the EU recommended that Member States monitor the presence of BFRs in food.