Cosmetic Compliance
Intelligence & Solutions
New Zealand Cosmetic Legislation
Mar 24, 2017
Jo Zhou
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CONTENTS

 New Zealand Cosmetics Legislation

Overarching Regulation
Hazardous Substances and New Organisms(HSNO) Act 1996
Competent Authority
Environmental Protection Authority (EPA)
Main Supporting Rules 
1 Jul 206Cosmetic Products Group Standard 2006
Nov 2011Policies and procedures for the New Zealand Inventory of Chemicals(NZIoC) 

Cosmetics in New Zealand are controlled under the scope of chemicals by Environmental Protection Authority (EPA), EPA control chemicals mainly by regulating new organisms and hazardous substances. Cosmetics which contain hazardous substances should comply with the overarching regulation “Hazardous Substances and New Organisms Act 1996”, and get approval from EPA before being manufactured/imported.

Besides, if hazardous substances in cosmetics are new and not listed on “New Zealand Inventory of Chemicals”, the new hazardous substances must be notified to EPA (new unhazardous is not mandatory). Also, EPA divides products with similar nature, type or use into groups and sets special standards for each group. Cosmetic Product Group is one of these groups which include almost all cosmetics and corresponding regulation “Cosmetic Products Group Standard 2006” stipulate special requirements such as labels and packing for this group.

Currently, EPA announced it will revise the overarching regulation “Hazardous Substances and New Organisms (HSNO) Act 1996”, the approval of importing/manufacturing a hazardous substance, the classification and other issues may be amended. The draft will be published soon.

Contents

Part 1 Regulatory Framework and Competent Authority

Existing Main Cosmetic Regulations in New Zealand

Type

Regulation

Remark

Effective Date

Status

Overarching

Hazardous Substances and New Organisms(HSNO) Act 1996

General Regulations to control hazardous substances, cosmetics containing hazardous substances should comply with this one

10 JAN 1996

In force, but is under reforming

supplementary

Cosmetic Products Group Standard 2006

Specify rules especially managing cosmetics such as label, claim, package

1 JUL 2006

In force, amended once in 2012

Inventory

Policies and procedures for the New Zealand Inventory of Chemicals(NZIoC)

Instruct how to notify a new chemical which not listed on NZIoC

NOV 2011

In force


Competent Authority of Cosmetics

Environmental Protection Authority (EPA) is the government agency responsible for regulatory functions concerning New Zealand’s environmental management, and mainly regulates new organisms and hazardous substances (which may be applied in cosmetics).

Part 2 Cosmetic Products

Definition of Cosmetic Products

cosmetic product means any product or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors.

Classification of Cosmetic Products

New Zealand classifies cosmetics by their functions:

Classification

Description

Rinse-off product

a cosmetic product which is intended to be removed after application on the skin, the hair or the mucous membranes

Leave-on product

a cosmetic product which is intended to stay in prolonged contact with the skin, the hair or the mucous membranes

Hair product

a cosmetic product which is intended to be applied on the hair of head or face, except eyelashes

Skin product

a cosmetic product which is intended to be applied on the skin

Lip product

a cosmetic product which is intended to be applied on the lips

Face product

a cosmetic product which is intended to be applied on the skin of the face

Nail product

a cosmetic product which is intended to be applied on nails

Oral product

a cosmetic product which is intended to be applied on teeth or the mucous membranes of the oral cavity but not swallowed

Product applied on mucous membranes

a cosmetic product which is intended to be applied on the mucous membranes i. of the oral cavity, ii. on the rim of the eyes, or iii. of the external genital organs

Eye product

a cosmetic product which is intended to be applied in the vicinity of the eyes

Professional use

the application and use of cosmetic products by persons in the exercise of their professional activity

Approval Compliance

The management core of EPA in New Zealand regulates ingredients (hazardous substances, new chemicals) used in product, rather than product itself. That means if your cosmetic products contain hazardous substances, you need to follow the relevant approval procedures like any other chemical products (petrol, agrichemicals) do. The EPA stipulates that if you are importing, manufacturing or using hazardous substances they must be approved under the Hazardous Substances and New Organism (HSNO) Act.

Note: Hazardous Substance is any substance that has one or more of the following properties above specified levels:

  • An explosive nature (including fireworks)

  • Flammability

  • Ability to oxidise (i.e. accelerate a fire)

  • Corrosiveness

  • Acute or chronic toxicity (toxic to humans)

  • Ecotoxicity, with or without bioaccumulation (i.e. can kill living things either directly or by building up in the environment)

  • Can generate a hazardous substance on contact with air or water.

Hazardous substances can have more than one hazardous property. For example, methylated spirits and petrol are flammable and toxic.

Two types of approval can be applied for: rapid assessment and full release application.

1. Rapid assessment:

To be eligible for a hazardous substance approval by rapid assessment, a substance must meet one of the following criteria:

  • It has a similar composition and similar hazardous properties to a substance that already has a HSNO approval (rapid similar); or

  • Its hazardous properties meet the criteria for low hazard (least degrees of hazard); or

  • It has been formulated so that one or more of its hazardous properties has a lesser degree of hazard than a substance that already has a HSNO approval (rapid reduced).

You will need to download the appropriate form and send the completed and signed application to EPA, along with the application fee.

Once EPA has received your application and payment, they will assess the pathway and determine if your substance is eligible for rapid assessment. If it is not, they will inform you and you may be required to pay a further fee (dependent on the correct pathway). The statutory processing time for a rapid application is 10 working days from formal receipt of an application to when the application is decided. 

2. Full Release Application

If an application to release a hazardous substance is not eligible for rapid assessment, then it may proceed as a non-notified application. However, if there is likely to be significant public interest in the application, it will be publicly notified. You will need to download the appropriate form and send the completed and signed application to EPA, along with the application fee.

Once EPA has received your application and payment, they will assess the pathway and determine if your application will need to be publically notified or not. Once this pathway assessment is complete they will inform you of the outcome. You may be required to pay a further cost if your initial fee does not cover the full cost. You will need to undertake consultation with Māori protection councils if risks of significance to Māori areas are identified either in your application form or by the EPA staff. (See more details on EPA)

Notify New Chemicals

Likewise, if your cosmetics contain new chemicals not listed on New Zealand Inventory of Chemicals (NZLoC), you have to complete a notification before manufacturing or importing.

The NZIoC is a database of all the hazardous chemical components of products approved under group standards. If you have a new product, you can check the list to see if all chemicals comply with it. If your cosmetics contain a hazardous chemical that is not listed on the NZIoC, you must notify with EPA (unhazardous new chemical is not mandatory to list on NZIoC).

Requirements to Notify Chemicals for the Inventory:

To notify a new hazardous chemical with EPA, you must submit following information in written form:

1. The name of the substance; and

2. The HSNO approval number and/or title of the Group Standard under which the substance has 3. Deemed approval; and

4. The name and CAS number of the chemical not listed on the Inventory of Chemicals that is present in the substance; and

5. The concentration of that chemical in the substance; and

6. The hazardous properties of the chemical, including the provision of the relevant hazard data used to assign the substance to the Group Standard; and

7. The proposed use of the substance.

How Do You Know If You Are Required to Notify?

Part 3 Cosmetic Standard Group

Apart from getting approval from EPA for hazardous substances and notifying new hazardous chemicals to NZIoC (rules apply to all chemical products), EPA also divide products with similar nature, type or use into groups and set special standard for each group.

Cosmetic Product Group is one of those groups described above. This group is managed under the Cosmetic Products Group Standard 2006 (amended 2012). The group standard is closely aligned to the European Cosmetics Directive. This Standard stipulates special requirements for cosmetics, such as nanomaterial notification, label, packaging, and cosmetic review, etc., and provides lists of ingredients that are allowed or prohibited to use in cosmetics

Notification of Nanomaterial in Cosmetics

Any person intending to import or manufacture a cosmetic product containing nanoparticles other than zinc oxide or titanium dioxide must, at the time they first import or manufacture the substance, must notify the EPA. Manufacturers or importers should notify with the following information in a written form:

1. The name of the substance; and

2. The HSNO approval number and/or title of the Group Standard under which the substance has a deemed approval; and

3. The nature of the nanomaterial the substance contains.

Labeling

1. Labels must contain a list of ingredients in accordance with the following priority:

  • A list of the ingredients in the product (except color additives) in concentrations of 1% or more in descending order by volume or mass; and

  • A list of the ingredients in the product (except color additives) in concentrations of less than 1% in any order; and

  • Color additives in any order; and

  • Flavor or flavors, which must be described in the list of ingredients by          

             (a) The words, ―flavor‖ or ―flavors‖ or ―aroma‖ or ―aromas‖; or

             (b) The ingredients in the flavor or flavors; and

  • Fragrance or fragrances, which must be described in the list of ingredients by:

            (a) The words, ―fragrance or ―fragrances or ―parfum‖ or parfums‖; or

            (b) The ingredients in the fragrance or fragrances.

2. A label must provide the following general information about a substance

  • Product name; and

  • Enough information to enable its New Zealand importer, supplier or manufacturer to be contacted whether in person or by telephone; and

  • Manufacturer‘s original source or batch code information

3. A substance that contains a component listed in Components Cosmetic Products Must Not Contain, Components Cosmetic Products Must Not Contain Except Subject To the Restrictions and  Conditions Laid Down, Colouring Agents Cosmetic Products May Contain With Restrictions, Preservatives Cosmetic Products May Contain With Restrictions, and UV Filters Cosmetic Products May Contain With Restrictions must comply with the relevant labeling requirements set out in those Lists.

4. Where there is a requirement to list ingredients under subclause 1, the list may be provided on:

  • The substance label; or

  • The outer container or carton if the substance is packed in an outer container or carton; or

  • A package insert or leaflet if the package is too small to include the details on the label; or

  • A leaflet at the point of sale.

5. Substances displayed for sale in tightly compartmentalized trays or racks, or used in conjunction with display units, may declare the ingredients in off-package labeling attached to the display rather than on each retail unit, provided that the total surface area of the substance is less than 80 cm2. This provision does not apply to substances that are contained in an outer package.

6. The ingredients may be declared using their common chemical names or their International Nomenclature Cosmetic Ingredient names.

7. All ingredients present in the form of nanomaterial shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ―nano‖ in brackets.

8. The requirements of this clause do not apply to free samples or testers.

9. When a substance is contained in a package with a capacity of 5 L or 5 kg or less, the label for that package does not need to provide the following information:

            i. The priority identifiers for any HSNO class 9 hazards as required by the Hazardous Substances (Identification) Regulations 2001; or

           ii.The emergency management response statements for any HSNO class 9 hazards as required by the Hazardous Substances (Emergency Management) Regulations 2001.

10. The requirements of subclauses 1 and 3 do not need to be met if the labeling is compliant with current labeling requirements for cosmetic products of Australia, USA, Canada or the European Union, as if the substance were for sale or supply in those countries.

Packaging

General packaging requirements for cosmetics include:

1. Select packaging that when filled and closed—

    i. Does not leak any substance under normal working conditions; and

    ii. Maintains its ability to retain its contents, if part of the contents are removed And the package resealed; and

    iii. Does not react with a substance in any way as to weaken the package; and

2. Ensure that, if a substance is being packed into a package that has previously contained another substance—

    i. Both substances are compatible; or

    ii. All practicable steps are taken to remove all residues of the original substance.

3. In the case of a substance with an aspiration hazard, when that substance is packaged in quantities of less than 2.5 L or 2.5 kg, that package must be child resistant, unless being sold or supplied to a place of work where children do not have access and the substance is for use in that place of work.

Note: These requirements do not apply to a substance that is packaged in an aerosol dispenser.

Packaging cosmetics under some circumstances in New Zealand should comply with UN Packing Group requirements. Details can be seen on Cosmetic Products Group Standard.

Reviewing Cosmetics

The manufacturer is responsible for the safety of their products, and must ensure that they undergo an expert scientific safety assessment before they are sold. It is reviewed regularly to take into account changes made to the EU Directive and other comparable jurisdiction