Child-resistant packaging

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Child-resistant packaging is intended to prevent small children who are not yet able to overcome a complex opening mechanism from coming into contact with the contents that are hazardous to health. For many products that pose a health risk to small children , their use is mandatory through national and international legislation.

General

Child-resistant packaging comes in numerous types. Packaging with closures that can be opened by pressing and turning at the same time are very often used. Other systems include, for example, blister packs and one-time dosing for liquid contents from the field of pharmaceutical products or child-resistant cardboard boxes , flow packs, bags with opening locks.

A number of internationally recognized standards define the requirements for child-resistant packaging. Testing and certification is carried out by certification bodies that are accredited according to EN 45011.

Products that must be packaged in a child-proof manner

The list of products to be backed up is extremely extensive. These include, among other things, chemical-technical household products such as aggressive cleaning agents , hardware store products such as acids , alkalis , formulations containing gasoline , products with high concentrations of essential oils such as lamp oils or cosmetics . In addition, drugs represent a significant potential hazard.

Norms

In Europe, various standards regulate the requirements for child-resistant packaging. ISO 8317 (2003) forms the standard for resealable packaging. For non-resealable packaging, DIN EN 862 (2006) for non-pharmaceutical products and DIN EN 14375 (2004) for pharmaceutical products apply. These standards have been adapted several times in the past.

The requirements for packaging used in the USA originate from the regulations according to US 16 CFR § 1700.20, regardless of the type and locking system.

Legal basis

European Union

In the European Union , the regulations for chemical-technical products such as household cleaners etc. are defined in Regulation (EC) No. 1272/2008 (CLP) . These stipulate that products with a certain risk to the health of small children may only be placed on the market in child-resistant packaging that meets the above standards.

Germany

In Germany, the Medicines Act (AMG) regulates the use of child-resistant packaging in a binding manner for the pharmaceutical sector . In Section 28 AMG, the highest federal authority is given the opportunity to issue provisions according to which medicinal products with certain active ingredients are to be packaged in a child-proof manner. The Federal Institute for Drugs and Medical Devices maintains a list of active ingredients for drugs to be packaged in a child-proof manner. The packaging of products containing these active ingredients must comply with the above standards.

There is no Europe-wide uniform regulation, but the standards ISO 8317 and DIN EN 14375 are recognized throughout Europe.

United States

In the USA, the above-mentioned regulation US 16 CFR § 1700.20 defines the uniform rules for dangerous chemical-technical, as well as for pharmaceutical products. In addition to many household products that are harmful to health, all prescription drugs, with a few exceptions, must be packaged in a child-proof manner. At the same time, US 16 CFR § 1700.20 specifies which requirements child-proof packaging has to meet. These are similar to the standards used in Europe, but more extensive for the pharmaceutical sector.

Testing and certification

Child-resistant packaging is only available if it conforms to the standards mentioned. Certification by an institute accredited according to DIN EN ISO / IEC 17065 (conformity assessment - requirements for bodies that certify products, processes and services) serves as recognized evidence of this.

responsibility

According to Directive 1999/45 / EC, the distributor is responsible for ensuring that the requirements with regard to child-resistant packaging are met. In the case of dangerous substances and preparations, this role is usually taken on by the filling company.

literature

  • Horst Antonischki: Child- safe and senior-friendly packaging. Hüthig, Heidelberg 2005, ISBN 3-7785-2959-5
  • Rolf Abelmann: Child-resistant packaging for pharmaceuticals: makes it difficult for children! In: Packreport 12, 2006
  • Order of an edition according to § 28 Medicines Act (child-proof packaging for. Medicines) of February 12, 1982. (BAnz No. 36 of February 23, 1982, p. 1), pdf , 65.1 kB
  • Child-resistant packaging for pharmaceuticals. Order of an edition according to § 28 Medicines Act of September 17, 1984. (BAnz No. 178 of September 20, 1984, p. 10683), pdf , 90.1 kB