Festivities and holidays around the world are celebrated by the giving of gifts, especially confectionery. Seasonal peaks in sales as people indulge themselves and their children, means increased production and pressure to meet market demands. Doing so safely requires close attention and adherence to regulatory standards and their worldwide variations.

International and national regulations exist to protect consumers, especially children. Key among these is regulations surrounding confectionery products, toys and other non-nutritive products, as well as contaminants and coloring agents.

Non-Nutritive Products

Regulators worldwide are naturally cautious when it comes to the inclusion of non-nutritive products and toys in confectionery and food products.

Banned from Sale in the US

In the US, the inclusion of toys and nonnutritive products in food is not allowed. For example, it is illegal to sell chocolate eggs that contain packaging with a toy inside in the US. This is because the toy and plastic inner are embedded inside it. The US Consumer Product Safety Commission (CPSC) has agreed with the US Food and Drug Administration (FDA) that these types of product pose a choking hazard. They are therefore banned from sale.

The US Food, Drug and Cosmetic Act of 1938 Section 342 (d) states: “A food shall be deemed to be adulterated – if it is confectionery, and – (1) has partially or completely imbedded therein any non-nutritive object, except that this subparagraph shall not apply in the case of any non-nutritive object if, in the judgment of the Secretary as provided by regulations, such object is of practical functional value to the confectionery product and would not render the product injurious or hazardous to health.”1

Exceptionally, in the US, if the nonnutritive material or toy is attached to the confectionery and serves a functional purpose, such as a stick to hold and will not cause injury or hazard to the consumer, then it is legal to be sold. The most common example of this product type is the ring pop. Provided a product of this type is appropriately labeled and complies with both FDA and CPSC regulations there are no issues with its marketing and sale. The FDA defers to the CPSC to assure that the toys meet their requirements for small part compliance and age related labeling.

EU Acceptability

The question of small toys in food items is viewed slightly differently within the EU. Toy Safety Directive 2009/48/EC2 require that toys contained in, and comingled with, food must have their own packaging. Additionally, any separable toy packaging which is spherical, egg shaped or cylindrical with rounded ends must be large enough to prevent it from blocking the airways when wedged in the mouth.

Packaging that is NOT SEPARABLE although is allowed.

non-complying cylindrical complying cylindrical
(Example of a non-complying cylindrical shaped packaging with rounded ends.) (Example of complying cylindrical shaped packaging with rounded ends, because the parts are not separable.)

Items similar to chocolate eggs that contain packaging with a toy inside can be legally marketed in Canada, Brazil, India, Indonesia, Israel, Taiwan, Hong Kong, Colombia, South Africa, Singapore, Malaysia, Argentina, Cameroon, Venezuela, Australia, New Zealand and some Middle Eastern countries, but not in the US.

Confectionery Contaminants

All regulators are concerned about the contamination of confectionery and other foodstuffs with potentially harmful substances but here also, the US and EU have divergent standards.

Low Lead Levels in the US

Confectionery imported from Mexico containing high levels of lead has brought about a change in US market requirements. The state of California has a lead in candy requirement that prohibits the sale of candy with lead content of more than 1 ppm.3 In 2005 the US FDA also revised their guidance for lead in candy likely to be consumed by small children4 reducing it from ≤0.5
ppm to ≤0.1 ppm.

In the EU there is concern about contaminants in foodstuffs, as established in EC 1881/2006. This sets maximum levels for certain contaminants in foodstuffs5, but there is no specific maximum standard for lead in confectionery. Not that candy with high levels of lead can be legally sold in the EU but the tolerance of lead in products is based on the provisional tolerable weekly intake (PTWI) of 25 ug/kg body weight (bw) as proposed by the World Health Organization (WHO) in 1986. These lead standards may change based on the European Food Safety Authority’s (EFSA) 2010 scientific opinion on lead in food, which states that this PTWI is no longer appropriate as a threshold for critical lead-induced effects particularly for children from the ages of 1 to 7.6.

Colorful Causes for Concern

Confectionery is often brightly colored to make it more attractive to children. Ensuring the safety of these Color additives is a priority for regulators over the world. However, there is no consolidated approach, which can make compliance more complex for manufacturers.

Many Colorants have issues in various countries, but yellow Colorants such as E102 Tartrazine (also known as FD&C Yellow 5 or Food Yellow No. 4), E104 Quinoline Yellow and E110 Sunset Yellow FCF (otherwise known as Orange Yellow S, FD&C Yellow 6 or Food Yellow No. 5) have a wide assortment of restrictions, labelling requirements and are even prohibited from use in some countries. The issue is further complicated by a lack of consistent naming across international boundaries.

Tartrazine, known as FD&C Yellow 5 in the US and Food Yellow No. 4 in Japan, is suspected to cause allergic and asthmatic reactions in a small amount of the population.7 Now controlled by EU directive 1881/2006 its use was once banned in Austria, Germany and Norway.

Quinoline Yellow is not approved for food in Japan and the US, but is approved in over 37 countries for food use. In the US, Quinoline Yellow is approved for use in drugs. Its non approval for food use in the US is because at high levels of consumption there is a potential risk of carcinogenicity.8

Sunset Yellow FCF, or Orange Yellow S, otherwise known as FD&C Yellow 6 in the US and as Food Yellow No. 5 in Japan, is controlled in the EU with directive 1881/2006. At one time its use was banned in Finland and Norway. As with Tartrazine, Sunset Yellow FCF is suspected of causing allergic and asthmatic reactions in a very small segment of the population.9 Described in most countries as yellow this Colorant is actually more orange in appearance than yellow.

Some countries such as the United Kingdom (UK) have asked the food industry to phase out the use of these Colorants, especially for products that are marketed to children. These countries require labelling to state that the product “may have an adverse effect on activity and attention in children”.10 EC 1333/2008 also requires this wording for all food products containing these Colorants.11

Protect Consumers and Your Business

Compliance is not optional, or accidental. It requires planning, industry and regulatory knowledge, as well as investment in safety and quality systems. Regulatory standards exist to protect both your business and your consumers.

  1. Food, Drug Cosmetic Act of 1938 Section 342 Adulterated Food
  2. Directive 2009/48/EC
  3. California Department of Public Health
  4. US FDA Lead in Candy Likely to be Consumed by Small Children
  5. Commission Regulation (EC) No. 1881/2066
  6. EFSA Scientific Opinion on Lead in Food
  7. EFSA Scientific Opinion on the re-evaluation Tartrazine
  8. EFSA Scientific Opinion on the re-evaluation of Quinoline Yellow
  9. EFSA Scientific Opinion on the re-evaluation of Sunset Yellow FCF
  10. Ministers agree food Color ban
  11. EC 1333/2008

Jim Cook
Consumer Testing Services
Food Safety Technologist
SGS North America, Inc.
t: +1 973 461 1493
Website: www.sgs.com/foodsafety

 About SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 70,000 employees, SGS operates a network of over 1,350 offices and laboratories around the world.