Balloons are popular mood boosters for parties, and a favourite toy for children. Although balloon pumps are very common, some people still tend to inflate balloons by mouth. Besides, as there have been balloon product recalls or accidents overseas from time to time, the Consumer Council tested a total of 35 samples of 19 latex balloon models. It was found that all samples released various types of nitrosamines and/or nitrosatable substances, some of which were suspected carcinogens, and nearly 70% (13 models) were found to have a total migration of such substances that exceeded relevant EU toy safety requirements, which was a worrying situation. The Council urges manufacturers to make immediate improvements to reduce migration of nitrosamines and related substances in their products, so as to ensure safety for consumer use. The Council also reminds consumers that it is difficult to reuse or recycle balloons made of latex, so it is advisable to consider replacing them with more eco-friendly decoration materials.
The Council purchased 11 single-colour or single-style balloon products and 8 mixed-colour or mixed-style products from different retailers, with prices ranging from $0.3 to $19.9 per balloon. The models that met relevant safety standards included both higher and lower priced products, reflecting that there is no necessary correlation between product price and safety level.
Over 90% Samples Released Nitrosamines in Different Concentrations
Certain accelerators might be used in the manufacturing process of latex balloons, which may result in the formation of nitrosamines and nitrosatable substances, whereas some preservatives used in raw latex may also be sources of nitrosamines. Some of these nitrosamines are suspected carcinogens and may also pose potential risks to human health. The ingested nitrosatable substances could be converted into nitrosamines in the human body, thus the migration amount of nitrosatable substances is also an important safety indicator.
The International Agency for Research on Cancer (IARC) classified 2 nitrosamines NDELA and NDBA as Group 2B, i.e. possibly carcinogenic to humans, and another nitrosamine NDMA as probably carcinogenic to humans (Group 2A). Animal studies have shown that if ingested orally, these substances might cause harm to organs such as the liver, kidneys, bladder, oesophagus, and nasal cavity, and might cause tumours in experimental animals. Although there is inadequate evidence to prove carcinogenicity in humans, the potential risk should not be ignored.
With reference to the European toy safety standard, a total of 35 balloon samples from 19 models were tested, including 8 models with 3 different colours/styles and 11 models with single colour/style. The samples’ safety was assessed based on the migration of nitrosamines and nitrosatable substances.
The European toy safety standard[1] stipulates that the total migration of nitrosamines in the elastomers used in balloons shall not exceed 0.05mg/kg, while the EU Toy Safety Directive[2] sets the same limit. Over 90% of the tested samples (32 samples) were found to release different types of nitrosamines, among which the total migration amounts of nitrosamines in over 30% of the samples (13 samples) ranged from 0.058mg/kg to 0.39mg/kg, exceeding the limit of the European standard and failing to comply with the relevant EU Directive’s requirement. 10 samples were detected with a higher total migration of nitrosamines, ranging from 0.106mg/kg to 0.39mg/kg, exceeding the limit by about 1.1 times to 6.8 times.
Among them, the migration levels of certain individual nitrosamine(s) in some samples were comparatively high. NDELA was detected in nearly 70% of the samples (24 samples), among which 5 had a migration level of 0.05mg/kg or above. In addition, NDMA and/or NDBA were detected in 27 samples, of which 9 had a higher migration level of NDMA or NDBA, ranging from 0.057mg/kg to 0.355mg/kg. The migration of individual nitrosamine compound in the relevant samples reached or even exceeded 0.05mg/kg. Overall, 20 samples were simultaneously detected with 2 or more nitrosamines such as NDELA and NDMA, or NDELA and NDBA, among which 1 was detected with both relatively high migration of NDELA and NDBA, at 2.58 times and 3.76 times of the migration limit respectively.
All Samples Detected with Nitrosatable Substances
Over Half Exceeded EU Requirement
All samples were found to release different amounts of nitrosatable substances, which could be converted into nitrosamines in the human body, which is also of much concern. The European standard and the EU Toy Safety Directive both set a limit of 1mg/kg for total migration of nitrosatable substances. The Council’s test found that over half of the tested samples (19 samples) had a total migration of nitrosatable substances ranging from 1.114mg/kg to 6.502mg/kg, exceeding the limit of the European standard and the relevant EU regulation. None of the samples were detected with NDELA, but the nitrosatable substances released by 26 samples were found to have converted to NDMA, with half having higher migration levels ranging from 1.037mg/kg to 5.605mg/kg, and the concentration of NDMA converted from the samples alone exceeded the relevant total migration limit.
Overall, only 6 models (12 samples) complied with the relevant EU toy safety regulations, while the total migration of nitrosamines and/or nitrosatable substances detected in the remaining 13 models (23 samples) exceeded the limits stated in the EU regulation, among which 9 samples were detected with total migration of both substances which did not comply with relevant requirements.
As for local legislation, under the Toys and Children’s Products Safety Ordinance, manufacturers, importers and suppliers are required to comply with all the requirements applicable to toys for sale contained in at least 1 of the 3 sets[3]of toy standards specified in its Schedule. Among the 3 sets of toy standards currently specified in Hong Kong legislation, only the European toy safety standard has set a limit on the migration of nitrosamines and related substances for balloon products. However, to strengthen consumer protection, the Council advises the industry to take heed of and make reference to the toy safety standards of different countries or regions, to avoid excessive migration of potentially harmful substances in their products. In fact, with state-of-the-art manufacturing technology, it is feasible to significantly reduce the formation of nitrosamines in latex products. The Council opines that it is absolutely achievable for manufacturers to switch to safer materials for the production of balloons to minimise consumers’ exposure to relevant substances through balloons.
In recent years, the studies conducted by overseas organisations have found that nearly 30% to 40% of the balloon samples in their locale had migration levels of nitrosamines or related substances that did not meet EU regulations, while the Council's test results found that nearly 70% of the balloons did not comply with the related EU regulations, reflecting that non-compliance was more prevalent in Hong Kong than overseas. The Council recommends relevant regulatory bodies to step up surveillance by making reference to relevant standards, so as to ensure that products supplied through different sales channels or modes of sale are all safe, and to study the adequacy of relevant legislation in terms of consumer protection in due course.
Some Models’ Labelling Non-Compliant with Hong Kong Regulations
Proper labelling could help consumers to use balloon products safely. 2 models had safety warnings only in English on their packaging, while the warning statements on 5 models had discrepancies between the English and Chinese, with some statements in English only. In addition, 5 models did not label the company name of the importer or supplier and their Hong Kong addresses. The Council has forwarded relevant product information to the Customs and Excise Department for follow-up. The Council reminds that it is a fundamental consumer right to receive accurate and comprehensive product information, thus manufacturers are urged to make improvements promptly to increase the transparency of product information.
Consumers may consider the following tips when purchasing and playing with balloons:
- Balloon products are difficult to reuse and recycle. Consumers are encouraged to choose eco-friendly or recyclable materials for decoration to support environmental protection;
- When using balloons, it is recommended to use an air pump to inflate them and avoid blowing directly with the mouth to help reduce contact with harmful substances;
- Children should be accompanied by adults when playing. Uninflated balloons should be stored properly, under-inflated or deflated balloons and broken balloons pose choking risks and should be discarded immediately;
- After playing with balloons, wash hands and face before touching food to avoid ingestion of harmful substances;
Consumers should exercise caution when purchasing non-packaged balloon products as they might not specify information such as the brand name, model number and country of origin, or display appropriate safety warnings.
[1] The European toy safety standard sets limits for elastomers used in balloons.
[2] The EU Toy Safety Directive sets limits for all toys that intended to be placed in the mouth.
[3] The 3 sets of standards include the European Standard BS EN 71, American Society for Testing and Materials ASTM F963, and the International Standard ISO 8124.
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