BIS has just published guidance notes on the UK Packaging (Essential Requirements) Regulations

This guide is addressed to those involved in the placing of packaged goods on the market. This guidance cannot cover every situation and, of course, it may be necessary to carefully consider the relevant legislation to see how it applies in your circumstances. However, if you do follow the guidance it will help you to understand how to comply with the law.

The essential requirements of this regulation are, in summary:
• Packaging volume and weight must be the minimum amount to maintain the necessary levels of safety, hygiene and acceptance for the packed product and for the consumer.
• Packaging must be manufactured so as to permit reuse or recovery in accordance with specific requirements.
• Noxious or hazardous substances in packaging must be minimised in emissions, ash or leachate from incineration or landfill.

A new list of harmonised standards has been published in the OJEU:

• Published : Sep 11, 2015 – OJ C 300
• Low Voltage Directive, (Directive 2006/95/EC)
• OJEU

There are 42 new, or updated, standards on this list

General Product Safety Directive 2001/95/EC:

OJEU List:

There are 16 new, or updated, standards on this list, all within the following categories:

• Child use and care articles
• Cycles – Safety requirements for bicycles
• Gymnastic equipment – Trampolines
• Safety of children’s clothing

BS EN 60601-1-2:2015 “Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests” has been published and is available through the BSI website article.

The most significant changes with respect to the previous edition include the following modifications:

• specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with iec 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments;
• specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable rf communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition;
• specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system;
• specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition; and
• better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term “life-supporting”;

and the following additions:

• guidance for determination of immunity test levels for special environments;
• guidance for adjustment of immunity test levels when special considerations of mitigations or intended use are applicable;
• guidance on risk management for basic safety and essential performance with regard to electromagnetic disturbances; and
• guidance on identification of immunity pass/fail criteria.