ANNEX A3: Legislation and Abbreviations

[Version 1 | Date: Feb 2016]

Legislation, regulations and standards

Suppliers of goods and services to Essity must comply with all applicable laws and regulations. The following list includes some, but not all, of the directives, legislation, regulations and standards applicable in the main markets where Essity does business. This list is not exhaustive and shall not relieve supplier of its obligation to comply with all legal and regulatory requirements applicable to the goods or services it provides.

It is supplier’s obligation to check and ensure that the most recent, up-to-date versions of the laws and regulations referenced here are identified and complied with.

International management and harmonized standards

• ISO 9001 Quality management systems – Requirements
• ISO 13485 Quality management systems for medical devices – Requirements
• OHSAS 18001 Occupational Health and Safety Management
• ISO 50001 Energy management Systems
• ISO 14001 Environmental management systems – Requirements
• ISO 14971 Risk management for medical devices
• ISO 10993 Biological evaluation of medical devices

http://www.iso.org/iso/iso_catalogue.htm

Product related directives and regulations

EU:

• 93/42/EEC: Directive concerning medical devices
• 1223/2009/EC: Regulation on cosmetics
• 1907/2006/EC: Regulation concerning the registration, evaluation, authorisation and restriction of chemicals (REACH) http://echa.europa.eu/
• 1935/2004/EC: Regulation on materials and articles intended to come into contact with food
• 2001/95/EC: Directive on general product safety
• 2011/65/EU : Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHSII)
• 2012/19/EU: Directive on waste electrical and electronic equipment (WEEE)
• 2006/66/EC: Directive on batteries and accumulators and waste batteries and accumulators
• 2008/1/EC: Directive on integrated pollution prevention and control
• 2009/48/EC: Directive on the safety of toys 648/2004/EC: Regulation on detergents
• 2006/95/EC: Low voltage directive
• 528/2012/EC: Regulation concerning making available on the market and use of biocidal products
• 1272/2008/EC: CLP Regulation
• 2009/28/EC: Promotion of the use of energy from renewable sources

http://eur-lex.europa.eu

USA:

• Consumer Product Safety Act 2008
• FDA 21 CFR 820: Medical Device regulations
• FDA 21 CFR 176 – Paper and paperboard components
• The Medical Device Reporting (MDR) regulation (21 CFR 803)
• Toxic Substances Control Act
• Federal Insecticide, Fungicide and Rodenticide Act.
• Federal Hazardous Substances Act (FHSA)
• California Proposition 65 – Safe Drinking Water and Toxic Enforcement Act

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm135680.htm

Australia/New Zealand:

• TGO AS/NZS 2869-2008 Therapeutic Goods Order - Standard for Tampons
• AS/NZS ISO 8124 Standard on Safety of Toys
• NICNAS: National Industrial Chemicals Notification and Assessment Scheme
• Industrial Chemicals (Notification and Assessment) Act 1989 (the Act).
• Australian Consumer Law (ACL)
• Australian regulatory guidelines for medical devices (ARGMD)

• SEPA order no 7 of the Measures on Environmental Administration of New
• Chemical Substances, “China REACH”
• CFDA: Order 650: Regulation on Medical Devices
• CFDA: Regulations Concerning the Hygiene Supervision over Cosmetics (1989)

System-related guidelines

• BfR Recommendations on Food Contact Materials
• BfR Guidelines for the evaluation of Personal Sanitary Products
• BfR Guidelines for the evaluation of Sanitary Papers
• IFS Household and Personal Care Standard, 28/07/2011
• BRC - British Consortium Standard, Issue 3 2010

• GMP - Good Manufacturing Practice
• GLP - Good Laboratory Practice