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When packaging is childishly easy to open it can become fatally dangerous. Manufacturers must offer hazardous household products and medications in childproof packaging. On the other hand they face the challenge of making the packaging easy enough for the growing number of senior consumers to handle.
There are national and international laws that are conceived to regulate the use of childproof packaging for household products and medications that represent a potential health hazard. The regulations stipulate precisely which products with which dangerous characteristics or ingredients may be put on the market in childproof packaging. They also dictate the standards that the packaging must fulfil in order to be considered childproof. In European regions, this is regulated for example through the EU Commission Directive 1999/45/EC (Dangerous Preparations Directive) and Council Directive 1967/548/EEC. In the USA, the basic laws are specified in US 16 CFR § 1700: Hazardous household products and almost all prescription medications may only be sold in the USA in childproof packaging.
Fundamentally, all products that are offered to consumers and are freely accessible such as household cleaners or highly combustible products that contain toxic, flammable, caustic or irritating ingredients fall under the regulations for products requiring childproof packaging. The provisions governing pharmaceutical products, however, are extremely inconsistent even within the EU.
International Differences
With the introduction of the "Poison Prevention Packaging Act", products that posed a threat to small children were required to be packaged in childproof packaging for the first time in 1970. Simultaneously standardised test methods for childproof packaging were developed. Soon thereafter similar standards were developed worldwide; these standards still vary, however, in size and composition of the samples, as well as in the evaluation methods. In addition, the laws regarding the use of childproof packaging vary internationally. A package can only be designated as childproof packaging according to the lawmakers if it fulfils the respective standards.
One example is ISO 8317 (2003), which corresponds to DIN EN ISO 8317 (2004) and is the international standard for reclosable childproof packaging, making it the most important standard. It is applied in the area of pharmaceutical and chemical-technical products. It describes two test methods that packaging must pass. In one test, a group of up to 200 small children between the ages of 42 and 51 months must not be able to open the packaging. They are first given five minutes time, after which they are shown how to open the packaging. They then have an additional five minutes time. The packaging is considered childproof if no more than 15% of the children are able to open the packaging during the first five minutes; no more than 20% may succeed in opening the packaging during the entire test. In another test, seniors between 50 and 70 years of age are given five minutes time to open the packaging, then an additional one minute of time, but without a demonstration. At least 90% must be able to open and properly reclose the packaging in order for it to be considered suitable for seniors. Older certificates or assessments according to ISO 8317 (1989) or DIN EN 28317 (1994) are no longer valid.
Additional standards include, for example, EN 862 (2005) for non-reclosable childproof packaging for non-pharmaceutical products, as well as EN 14375 (2003) for non-reclosable pharmaceutical packaging. The latter affects primarily blister packs for tablets, but also stick packs or granule bags. Compliance with the standard can be verified through a certificate from an EN 45011-accredited certification authority.
In Detail
One detail states, for example, that a closure alone — without a container —cannot be childproof. Only an entire package can be childproof, regardless of the fact that we often refer to childproof caps in everyday language. For the same reason there are no childproof films; they can only be certified in combination with a defined blister lower portion.
There is no requirement to label childproof packages, and according to ivm Institut VerpackungsMarktforschung GmbH, very few packages are properly labelled. The use of childproof packaging will grow in the future. Manufacturers and packers would do well to consider the topic of child safety at an early stage. On the other hand it is important to do justice to the demographic shift and the associated increase in the number of seniors.
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