compliance

Introduction

Ensuring compliance with applicable product regulations and safety standards is arguably one of the more difficult and risky aspects of importing products. This module helps you understand the basic concepts of product compliance, and how the process works in practice.

Disclaimer

Information in this module is provided for educational purposes only. 

The content contains only general information about product safety, labeling, documentation, testing, risks, and other product compliance-related topics. It is not legal advice, and should not be treated as such. 

Further, we don’t guarantee that the information provided in this tutorial is up to date, covering all possible scenarios or exemptions, all-encompassing or accurate. 

Also, we generally don’t cover European national and US state standards/regulations/requirements.

Objectives

+ Understand the basic concepts of product compliance

+ Understand importer responsibility

+ Understand applicable product regulations

 

 

Follow this process to assess applicable product regulations, safety standards, labeling requirements, document/certification requirements, licenses/permits, testing requirements and more.

 

1 Basic Concepts

 

This tutorial serves as an introduction to the basic concepts of product compliance, including product regulations, safety standards, chemicals, and heavy metals regulations, labeling and documentation/certification.

Product Regulations

Product regulations generally apply to specific product categories, materials or consumer age groups. In addition, one or more product regulations may apply to a specific product.

Examples

  •   Product-specific regulations (e.g. Electronics)
  •   Material-specific regulations (e.g. Food contact materials)
  •   Age-group specific regulations (e.g. Products for children aged 12 or younger)
  •   Substance regulations (e.g. Chemicals and heavy metals)

Scope

Some product regulations cover basic labeling rules, while other regulations are more comprehensive. Generally, product regulations can be broken down into the following components:

  •   Product safety requirements/standards
  •   Substance restrictions
  •   Labeling requirements
  •   Documentation/certification
  •   Lab testing requirements
  •   Pre-import approvals

Understanding these components is crucial when assessing what product compliance means in practice. Each part will be covered in greater detail throughout this course.

Product Standards

Product standards outline technical specifications and can be used as reference points when ensuring compliance with relevant product regulations. In a way, product standards are the building blocks that help you fulfill the requirements outlined by certain product regulations. Further, your product can also be lab tested according to certain product standards.

Scope

  •   Electrical safety
  •   Physical/mechanical properties (e.g. sharp edges)
  •   Flammability
  •   Quality standards
  •   Testing standards

 

Mandatory product standards

Some product regulations reference specific product standards. It’s generally up to the importer or manufacturer to assess which product standards apply to a certain product. 

Each product standard must then be implemented on a design stage to ensure that the product is fully compliant.

This makes sense, as product regulations generally apply to broad categories of products. However, the unique nature of each product means that only certain standards are applicable to a given product.

Voluntary product standards

Some product standards are not mandatory, in the sense that compliance is required before you start selling a certain product. 

However, keep in mind that you importers and domestic manufacturers are always liable for ensuring that their products are safe – regardless of whether product-specific regulations and/or standards apply.

It’s therefore in your interest to do your utmost to ensure that your product is safe. 

As such, voluntary standards are still highly relevant as a general product safety roadmap and reference point.

Substance Regulations

Substance regulations restrict certain chemicals, heavy metals, and pollutants. Products containing restricted substances above a certain limit are illegal to import or sell. 

Notice that some substance regulations apply to all consumer products, while others apply only to children’s products or certain materials.

Scope

  •   Chemicals
  •   Heavy metals
  •   Pollutants

Labeling Requirements

Labeling requirements may be part of a certain product regulation or apply broadly to all consumer products.

 Labeling requirements may apply both to the product and its packaging.

Scope

  •   Compliance marks
  •   Warning labels
  •   Country of origin
  •   Traceability codes

Documentation/Certification

Documentation requirements generally refer to mandatory self-issued declarations/certificates, user manuals, technical documents, test reports, and other relevant paperwork.

Scope

  •   Self-Issued Declaration/Certificates
  •   User manuals
  •   Technical documents
  •   Test reports
  •   Factory documents
  •   Pre-import permits

 

Test Reports

Lab test reports are often part of the mandatory documentation requirements when importing or selling products.

Permits

Pre-import permits and licenses are generally not mandatory when importing or export most products to the United States, the European Union or other developed countries. However, there are some exemptions,

Product Testing

Third-party lab testing verifies if a product conforms to certain product standards and/or substance regulation. 

A test report is issued once the lab test is completed, which is then used as proof of compliance – assuming the test is passed.

Mandatory Testing

Third-party lab testing is mandatory for certain products, in particular toys and other children’s products, electronics, machinery, and food contact materials.

Voluntary Testing

Third-party lab testing is voluntary for most consumer products. 

That said, importers and manufacturers are generally required to ensure that the product is safe and compliant. 

Few importers and manufacturers have the expertise and equipment to verify if a product is compliant.

As such, third-party lab testing is still de-facto mandatory as it’s the only viable way to verify if a product is compliant.

Accepted/Accredited Lab Testing Companies

Government bodies may only accept test reports issued by specific companies.

 For example, CPSIA testing can only be conducted by CPSC accepted testing companies.

Testing Costs

Lab testing costs are generally paid for by the buyer. Note that the testing costs can range from less than a hundred dollars to several thousand. 

The cost generally depends on the following factors:

  •   Number of applicable standards/regulations/substances
  •   Number of materials
  •   Number of colors
  •   Number of components
  •   Number of tests required per material/color/component

List of Testing Companies

  •   QIMA
  •   Bureau Veritas
  •   SGS
  •   Intertek
  •   TUV
  •   CMA
  •   Eurofins

Importer Responsibility

Note that the importer is de-facto responsible for ensuring that all imported products are fully compliant. The authorities generally only go after importers in case of compliance issues, in which case any of the following may occur:

  •   Products withheld by the customs authorities
  •   Forced product recall
  •   Fines

Amazon

All products sold on Amazon must comply with the applicable product regulations in the relevant country or market. 

Amazon is generally strict when it comes to verifying the compliance of listed products. Here is a summary of the information they may request before or after a product listing:

  •   Test reports
  •   Certificates
  •   Product photocopies
  •   Packaging photocopies
  •   Third-party compliance assessment documents
  •   Supplier invoices

FAQ

What if there are no applicable regulations/standards for my product?

The basic concept of product safety is that all products are safe for the consumer to use, under ‘foreseeable usage conditions’. 

As such, you shall assess how your product may be used, and ensure that the product is designed with safety in mind, regardless of whether or not there are applicable product-specific standards.

Can we assume that a product is compliant if it’s already sold in a certain country?

No, this is not the case. Test reports and other documents must be issued in the Importers name, not the suppliers. 

As such, it doesn’t matter if the exact same product (made by one and the same supplier) is already sold in your country – as you still have to go through all compliance steps for your product.

Can we use test reports owned by our supplier?

Test reports are generally only valid if they are issued in the name of the Importer, and valid for the relevant product. 

You cannot use an old test report, valid for another product, to prove that your products are compliant.

This is the case even if you import private label products, and the supplier happens to have a test report for the same product. 

As you cannot prove that the tested product was made using the exact same materials and components – old test reports cannot be applied to products manufactured at a later date.

Can we ask our supplier to test the product?

Manufacturers don’t have the expertise and equipment to handle lab testing. 

Further, some regulations only accept test reports issued by accepted third-party testing companies.

 

2 Supplier Check

 

Far from all suppliers outside the EU can ensure compliance with mandatory product regulations and standards. 

Some suppliers have no experience manufacturing products in compliance with EU standards, while other suppliers do.

To assess your supplier’s ability to manufacture compliance products, you must review their existing compliance track record. 

This is done by requesting, reviewing and verifying their existing test reports.

Why? Suppliers with a verifiable compliance track record (e.g. existing test reports) are far more likely to have the expertise and material supplier network necessary to manufacture compliant products.

Note: Test reports are generally only valid if they are issued in the name of the Importer, and valid for the relevant product. 

You cannot use an old test report, valid for another product, to prove that your products are compliant.

Step 1: Request test reports

Contact your supplier to request test report files. We recommend that you use this template when doing so:

Do you have any of the following test reports valid for [PRODUCT] in [INSERT COUNTRY]?

  •   Insert regulation/standard
  •   Insert regulation/standard
  •   Insert regulation/standard

Note that we need these documents to assess your capability to manufacture products that we can legally sell in our country.

Step 2: Test report review

 Regulation/Standard: The test report shall be valid for the relevant product standard and/or regulation.

 Product/Material/SKU: The test report shall be valid for a relevant (related) product/model.

 Held by: The company name shall match that of your suppliers

 Issued by: The test report shall be issued by an accredited testing company

 

Step 3: Verification

  1. Find the issuing company on the test report (e.g. QIMA or SGS)
  2. Use the test report/certificate verification system on their website by inputting the test report/certificate number or use the contact form to request a manual verification
  3. The issuing company normally confirms the validity of the test report within 3 days

Notice: Disqualify the supplier if they provided a fake or altered test report

 

3 Overview: United States

 

This tutorial is a general overview of relevant product regulations, standards, labeling, documentation and lab testing requirements. 

Note that this tutorial may not cover every single product regulation, standard or other requirement applicable to your product. 

Further, some standards, regulations, and requirements may not be applicable to your product.

Content Overview

 

Read this

  1. Information on this page/website is provided for educational purposes only. The content contains only general information about product safety, labeling, documentation, testing, risks, and other product compliance-related topics. 

It is not legal advice, and should not be treated as such. Further, we don’t guarantee that the information provided in this tutorial is up to date, all-encompassing or accurate. 

Also, we generally don’t cover European national and US state standards/regulations/requirements.

  1. Lab testing companies, such as QIMA and Intertek, can help you confirm currently applicable (mandatory and voluntary) product standards and regulations when you request a free lab testing quotation.
  2. Product regulations, standards, and other requirements are subject to updates and changes, and new regulations may be added. Note that lab testing companies, such as QIMA and Intertek, generally keep track of new regulations, standards, and other requirements.
  3. You must contact all relevant national/state authorities (see Additional Resources for examples) to request information on applicable product regulations, standards, and other requirements. 

Note that we don’t guarantee that Tutorial 6.3 is kept up to date or is entirely accurate.

  1. Products of any type or category designed for children are generally subject to mandatory children’s product safety standards.
  2. Product regulations may cover safety standards, documentation/certification requirements, labeling, packaging, and testing requirements.
  3. The information on this page is a complement to 6.4: Compliance Assessment and 6.5: Task List.

California Proposition 65

California Proposition 65 restricts more than 800 chemicals and heavy metals in all consumer products sold in California.

As such, products that contain excessive amounts (e.g. above the max limits) cannot be sold in California.

Examples of restricted substances

  •   Lead
  •   Cadmium
  •   Mercury
  •   Phthalates

California Proposition 65 Lab testing

We recommend that you book lab testing prior to importing products to the United States. 

Third-party lab testing is the only way to verify that your product is compliant with California Proposition 65.

Note that most manufacturers in Asia cannot provide CA Prop 65 test reports.

Testing costs

California Proposition 65 third-party lab testing costs are based on the number of products, materials, and colors. 

Testing costs start at around $200 but can increase the many times that based on the mentioned factors.

Warning Labeling

California Proposition 65 third-party testing is generally not mandatory if you attach a warning label to the product or its packaging. However, if you don’t wish to attach a warning label, you must verify that the product is compliant through third-party testing.

Additional Resources

  1. About Proposition 65 (Link)

Country of Origin

Country of origin marking is mandatory for most products imported and sold in the United States. 

The product and the packaging must have a permanently affixed country of origin label. As such, a sticker is not enough.

Examples

  •   Made in China
  •   Made in Vietnam
  •   Made in India

Label file

You must create a country of origin file and submit it to your manufacturer before starting mass production. 

We recommend that you provide a country of origin label file in .ai or .eps formats.

Additional Resources

  1. Marking of Country of Origin on U.S. Imports (Link)

CPSC Standards

Federal Hazardous Substances Act (FHSA) and other CPSC standards and substance restrictions limit the usage of certain substances, such as lead and formaldehyde. 

Third-party lab testing from a CPSC accepted company is not always mandatory when it comes to non-children’s products.

Examples of restricted substances

  •   Formaldehyde
  •   Lead

Lab Testing

We still recommend that you book lab testing from a CPSC accepted lab testing company as this is the only way to verify if your product is safe for your customers.

Additional Resources

  1. CPSC Regulations, Laws & Standards (Link)
  2. CPSC Regulations, Mandatory Standards and Bans (Link)

General Certificate of Conformity (GCC)

The GCC is a document issued by the importer or manufacturer of certain non-children’s products. 

The GCC is essentially a statement from the importer or the manufacturer, certifying that the product is lab tested and compliant with relevant CPSC and ASTM safety standards.

The GCC is identical to the Children’s Product Certificate (CPC). That said, the GCC is only applicable to certain products, while the CPC is mandatory for all children’s products imported and sold in the United States.

Content Summary

  1. Product name and description
  2. List of applicable CPSC safety rules and ASTM standards
  3. Your company name
  4. Contact details: Mailing address, e-mail address, phone number
  5. Name of the person holding the test report
  6. Date (month, year) and place (city, country) of production
  7. Date (month, year) and place (city, country) of product testing
  8. Third-party testing company, contact person, e-mail, phone number and address

Additional Resources

  1. CPSC General Certificate of Conformity (Link)
  2. GCC Sample (Link)

ASTM Standards

Compliance with ASTM standards is generally voluntary. That said, ASTM standards can be utilized at a product development stage to ensure that the product is safe to use.

ASTM also provides testing methods and procedures, which serve as an excellent reference point when it comes to verifying that your product reaches high quality and safety standards.

Note: Unsafe products are subject to forced recalls, even in case there are no mandatory safety standards for your product. It is therefore always in the interest of the manufacturer or importer to ensure that the products are safe.

You can search for ASTM product standards on their official website.

ASTM testing

SGS, Intertek, QMIA, Bureau Veritas, and other established third-party testing companies offer ASTM lab testing services. 

Note that most manufacturers don’t have the equipment and expertise to carry out ASTM testing.

Product Packaging

Importers and manufacturers must also ensure that the packaging materials are compliant. 

Below follows a brief summary of US packaging requirements.

Heavy Metals Restrictions

Many US states restrict lead, cadmium, mercury, and other heavy metals in packaging materials, printing inks, and dyes. 

Third-party lab testing is the only available method to verify if your packaging materials are compliant.

Intertek, SGS, TUV, QIMA and other product testing companies offer packaging materials testing services.

Labeling Requirements

Product labeling requirements, such as country of origin and compliance marks, may also need to be printed on the product packaging.

Bag Suffocation Warning

Bag suffocation warning label texts are mandatory for all Amazon sellers and in certain US states. 

Below you find an example and some additional resources.

Amazon Example

Warning: To avoid the danger of suffocation, keep this plastic bag away from babies and children. 

Do not use this bag in cribs, beds, carriages, or playpens. This bag is not a toy.

Additional Resources

  1. States with Toxics in Packaging Laws (Link)
  2. Bag Suffocation Warning (Link)

Additional Resources

Agency Products / Area Description Website
CPSC Apparel, Textiles, Toys, Children’s Products, Watches, Jewelry, Accessories, General Consumer Goods, Other The U.S. Consumer Product Safety Commission (CPSC) administers and develops product regulations and substance bans. It also issues recalls of products that have already been placed on the market.

On the website, you can find information about product standards and substance restrictions.

Click here
Small Business Ombudsman (CPSC) Apparel, Textiles, Toys, Children’s Products, Watches, Jewelry, Accessories, General Consumer Goods, Other The CPSC offers a free online advisory service for small businesses.

The Small Business Ombudsman can offer you quick and free guidance on all CPSC regulations.

Click here
FTC n/a The Federal Trade Commission (FTC) monitors business practices. On its website, you can find information about labeling requirements and other trade regulations. Click here
CPB n/a The U.S. Customs and Border Protection collects import duties and enforce trade regulations. On its website, you can find information about labeling requirements and other trade regulations. Click here
OEHHA General Consumer Goods Office of Environmental Health Hazard Assessment (OEHHA) is a California state department, which develops and administers CA Prop 65. Click here
FDA Food Contact Materials, Food & Beverage, Medical Devices The Food and Drugs Administration (FDA) develops and enforces regulations related to food contact materials, food products, medical products and other. Click here
FCC Electronics The Federal Communications Commission (FCC) regulates electromagnetic compatibility (EMC) in electrical devices. This includes technical standards, document requirements and labeling requirements. Click here

Notes 

  1. Additional regulations may apply in your state. Contact your local authorities to confirm if any additional regulations or substance bans are in place.
  2. We generally recommend that you create a traceability code or your products (e.g. SKU-MMYYYY-CN)

  

4/ Overview: European Union

  

This tutorial is a general overview of relevant product regulations, standards, labeling, documentation and lab testing requirements. 

Note that this tutorial may not cover every single product regulation, standard or other requirement applicable to your product. 

Further, some standards, regulations, and requirements may not be applicable to your product.

Content Overview

Read this

  1. Information on this page/website is provided for educational purposes only. 

The content contains only general information about product safety, labeling, documentation, testing, risks, and other product compliance-related topics. It is not legal advice, and should not be treated as such. 

Further, we don’t guarantee that the information provided in this tutorial is up to date, all-encompassing or accurate. 

Also, we generally don’t cover European national and US state standards/regulations/requirements.

  1. Lab testing companies, such as QIMA and Intertek, can help you confirm currently applicable (mandatory and voluntary) product standards and regulations when you request a free lab testing quotation.
  2. Product regulations, standards, and other requirements are subject to updates and changes, and new regulations may be added. 

Note that lab testing companies, such as QIMA and Intertek, generally keep track of new regulations, standards, and other requirements.

  1. You must contact all relevant national/state authorities (see Additional Resources for examples) to request information on applicable product regulations, standards, and other requirements. Note that we don’t guarantee that Tutorial 6.3 is kept up to date or is entirely accurate.
  2. Products of any type or category designed for children are generally subject to mandatory children’s product safety standards.
  3. Product regulations may cover safety standards, documentation/certification requirements, labeling, packaging, and testing requirements.
  4. The information on this page is a complement to 6.4: Compliance Assessment and 6.5: Task List.

REACH

REACH is an EU regulation that restricts chemicals, heavy metals, and pollutants in all consumer products sold in the European Union.

Consumer products, containing excessive amounts of restricted substances are not legal to import and sell in the European Union.

Here are a few examples of regulated substances:

  •   Lead
  •   Cadmium
  •   Mercury

Substances of Very High Concern (SVHC)

Each year, the EU adds new substances to the list of restricted chemicals and heavy metals. 

That said, importers don’t need to keep track of these substances. Instead, third party testing companies will help you keep track of which substances to include in the lab test.

Lab testing

Third-party lab testing is the only way to verify that your products are REACH compliant. 

There are various companies offering REACH testing, including SGS, Bureau Veritas, QIMA, and TUV.

We recommend that you book REACH compliance testing before your products are shipped to the EU. 

Further, it’s also essential to instruct your supplier before placing the order that the products must pass third party REACH testing.

Testing companies

Here are some companies offering REACH compliance testing:

  •   QIMA
  •   Bureau Veritas
  •   Intertek
  •   SGS
  •   TUV

Costs

The REACH compliance testing cost depends entirely on the number of different items, colors, and colors. In general, testing starts at $200 per material.

Additional Resources

  1. REACH (EC 1907/2006) (Link)
  2. ECHA: You are importing, producing or supplying articles (Link)
  3. ECHA: Importer (Link)
  4. Intertek: REACH Importer Obligations (Link)

CE Marking

Products regulated by one or more CE Directives must carry the CE mark, which indicates that the product is compliant with all applicable EU directives for which CE marking is mandatory. 

The CE mark must be permanently affixed to the product, packaging, and the user manual. As such, a sticker or other temporary solution is not enough.

Products Categories (Examples)

  •   Electronics
  •   Toys
  •   Machinery
  •   Protective equipment
  •   Construction materials
  •   Medical Devices
  •   Vehicles

CE Directives (Examples)

  •   Low Voltage Directive (LVD)
  •   Electromagnetic Compatibility (EMC) Directive
  •   RoHS Directive
  •   Radio Equipment Directive
  •   Medical Devices Directive
  •   Machinery Directive
  •   Toy Safety Directive (EN 71)
  •   Eco-Design Directive
  •   Personal Protective Equipment (PPE) Directive

Additional Resources

  1. CE marking (Link)
  2. When is CE marking mandatory? (Link)
  3. List of EU directives/regulations/standards (Link)

CE label file

You must provide a digital CE label file to your supplier, preferably in .ai or .eps format. In addition, you must also specify the following:

  •   Dimensions
  •   Position
  •   Color
  •   Print type

You may also need to include the CE mark in your packaging artwork and user manual files.

Product Traceability

In addition to the CE mark, you may also need to affix a permanent traceability code to the product and its packaging. 

The traceability code can include the following information:

  •   SKU
  •   Manufacturing date
  •   Production facility
  •   Country code

Example: SKU-YYMM-01-CN

CE Documentation

CE compliance requires more than the printed CE mark itself. 

In addition, you also need to issue a range of documents, including a Declaration of Conformity, User Manual and Technical File.

Declaration of Conformity (DoC)

The Declaration of Conformity is a document issued by either the importer or the manufacturer, which includes the following information:

  •   Produce identification/SKU (e.g. Model A)
  •   Product features
  •   Name and address of the manufacturer/importer
  •   List of EN standards or directives
  •   Location
  •   Responsible individual

The DoC is the primary document used to demonstrate compliance to government bodies, retailers and even end-consumers.

User Manual

You must also create a user manual for your product. Here’s a basic overview of the items you must include:

  1. Instructions on how to install the product
  2. An overview of the relevant parts and part names of the product
  3. Safety instructions
  4. Instructions on how to use the product
  5. Instructions on how to recharge and/or refill the product and
  6. Instructions on how to dispose of the product in an environmentally friendly manner

It’s also common to include the CE mark and WEEE mark in the user manual, as there may not be space on your product to print these symbols.

Technical File

In addition, you must also create a technical file, which shall include all relevant design, material, labels, packaging, and other files. 

It’s similar to your product specification in most aspects.

  •   Bill of materials
  •   Design drawings
  •   Label files
  •   Packaging files
  •   List of applied standards and directives (e.g. RoHS)
  •   Test reports
  •   QC reports
  •   Risk assessment

Test Report

Your technical file must also include relevant test reports. 

These test reports should also correspond to the EN standards or directives stated on the Declaration of Conformity.

Additional Resources

  1. Technical documentation and EU declaration of conformity (Link)

General Product Safety Directive (GPSD)

The purpose of the General Product Safety Directive (GPSD) is to ensure that all products are safe, even if no product specific or mandatory EN standard exists for a certain product. 

As such, the GPSD is applicable to all products sold in the EU.

GSPD compliance is based on self-assessment. In practice, this means that importers need to assess product safety and risks and ensure that the product design is not flawed or pose a risk to consumers using the product.

Notice that you must consider the behavior of not only adults but also young children and infants.

GPSD Documentation

It’s recommended to create a risk assessment document, to establish the potential safety hazards.

GPSD Testing

Third-party GPSD testing is not mandatory. However, general safety testing can still be conducted by a third party inspection company or the importer to assess general product safety.

CE Marking

The General Product Safety Directive (GPSD) is not a CE marking directive. That said, CE marking is required if your product is covered by one of the 25 CE marking directives.

Additional Resources

  1. General Product Safety Directive (Link)
  2. ProductIP.com: General Product Safety Directive (Link)

EN Standards

Following certain EN standards is generally voluntary (unless required by a directive/product regulation). 

That said, EN standards can be utilized at a product design stage to ensure that the product is safe to use.

EN standards also provide testing methods and procedures, which serve as an excellent reference point when it comes to verifying that your product reaches high quality and safety standards.

Note: The General Product Safety Directive (GPSD) requires that all products imported and sold in the European Union are safe for the consumer. This is the case even if no mandatory product-specific standards, directives or other regulations apply. 

It’s therefore in your interest to follow relevant EN standards when designing and manufacturing products.

You can search for EN standards for your product on shop.bsigroup.com.

EN testing

SGS, Intertek, QMIA, Bureau Veritas, and other established third-party testing companies offer EN standards lab testing services. 

Note that most manufacturers don’t have the equipment and expertise to carry out EN standards testing.

Additional Resources

  1. What is a European Standard (EN)? (Link)

Directive 94/62/EC: Packaging Regulations

Importers and manufacturers must also ensure that the packaging materials are compliant. 

Below follows a brief summary of packaging materials and waste requirements in the European Union.

Heavy Metals Restrictions

Directive 94/62/EC limits heavy metals, including lead, mercury, and cadmium in packaging materials, printing inks, and dyes. 

Third-party lab testing is the only available method to verify if your packaging materials are compliant.

Intertek, SGS, TUV, QIMA and other product testing companies offer packaging materials testing services.

Additional Packaging Information
  1. Packaging design and material should enable and simplify the collection, reuse, and material recycling.
  2. Product labeling requirements, such as compliance marks, may also need to be printed on the product packaging.

Additional Resources

  1. Packaging and Packaging Waste (Link)

Additional Resources

Country Description Website
EU Harmonised Standards Overview ec.europa.eu
United Kingdom Trading Standards www.tradingstandards.uk
Germany Bundesinstitut fur Risikobewertung www.bfr.bund.de
Netherlands Netherlands Food and Consumer Product Safety Authority www.nvwa.nl
France French Agency for Food, Environmental and Occupational Health Safety (ANSES) www.anses.fr
Italy REACH – Prodotti Chimici: informiamo i cittadini www.reach.gov.it
Spain Agencia Española de Consumo, Seguridad Alimentaria y Nutrición (Aecosan) www.aecosan.msssi.gob.es
Sweden A. Konsumentverket

B. Keminspektionen

A.www.konsumentverket.se

B.www.kemi.se

Notes 

  1. Additional regulations may apply to your country. Always consult your local consumer goods surveillance authority, to confirm all applicable regulations and substance restrictions.
  2. You can buy a complete compliance requirements list for your product on ProductIP.com.
  3. We generally recommend that you create a traceability code or your products (e.g. SKU-MMYYYY-CN)

 

5 Overview: Australia

  

This tutorial is a general overview of relevant product regulations, standards, labeling, documentation and lab testing requirements. 

Note that this tutorial may not cover every single product regulation, standard or other requirement applicable to your product. 

Further, some standards, regulations, and requirements may not be applicable to your product.

Content Overview

 

Read this

  1. Information on this page/website is provided for educational purposes only. The content contains only general information about product safety, labeling, documentation, testing, risks, and other product compliance-related topics. 

It is not legal advice, and should not be treated as such. Further, we don’t guarantee that the information provided in this tutorial is up to date, all-encompassing or accurate. Also, we generally don’t cover European national and US state standards/regulations/requirements.

  1. Lab testing companies, such as QIMA and Intertek, can help you confirm currently applicable (mandatory and voluntary) product standards and regulations when you request a free lab testing quotation.
  2. Product regulations, standards, and other requirements are subject to updates and changes, and new regulations may be added. 

Note that lab testing companies, such as QIMA and Intertek, generally keep track of new regulations, standards, and other requirements.

  1. You must contact all relevant national/state authorities (see Additional Resources for examples) to request information on applicable product regulations, standards, and other requirements. 

Note that we don’t guarantee that Tutorial 6.3 is kept up to date or is entirely accurate.

  1. Products of any type or category designed for children are generally subject to mandatory children’s product safety standards.
  2. Product regulations may cover safety standards, documentation/certification requirements, labeling, packaging, and testing requirements.
  3. The information on this page is a complement to 6.4: Compliance Assessment and 6.5: Task List.

a. Product Regulations & Standards

Mandatory AS/NZS Standards

Mandatory safety standards specify minimum requirements that products must meet before they are imported and sold in Australia. 

The Australian Competition & Consumer Commission (ACCC) publishes a list of mandatory safety standards:

Product Categories

  •   Toys
  •   Children’s Products
  •   Children’s Clothing
  •   Furniture & Home Products
  •   Bikes & Helmets
  •   Lighters
  •   Water Bottles
  •   Sports & Fitness Products

Notice: Additional products / categories may be added.

 

AS/NZS Standards Scope

AS/NZS standards vary in scope. However, they include at least one of the points listed below.

  •   Performance
  •   Composition
  •   Chemicals and heavy metals
  •   Methods of manufacture or processing
  •   Design
  •   Construction
  •   Finish
  •   Labels
  •   Packaging

Other AS/NZS Standards

Additional (mandatory or voluntary) product specific standards may apply. You can search the following relevant standards using the following databank:

We suggest that you purchase all relevant AS/NZS product standard files (if any), and carefully read the file/s to understand how the standard impacts:

  •   Performance
  •   Composition
  •   Chemicals and heavy metals
  •   Methods of manufacture or processing
  •   Design
  •   Construction
  •   Finish
  •   Labels
  •   Packaging

Products may be recalled if deemed unsafe, even if there are no applicable mandatory AS/NZS standards. 

As such, it’s in your interest to ensure that the imported products are ‘generally safe’, which is why voluntary AS/NZS standards are still highly relevant.

Notice: Some standards may also include labeling and documentation requirements.

Product bans

Some products, chemicals, and materials are banned in all Australian states.

Link: Product bans

b. Labeling Requirements

AS/NZS Labels

Both mandatory and voluntary AS/NZS standards may include highly specific labeling requirements, such as warning labels.

Import label

Some products (but not all) must be labelled with a trade description before they can be imported into Australia. The label shall match the following criteria:

  •   Description of the goods
  •   Country of origin
  •   English language

The label can be placed on the packaging or the product.

Tracking Label

You may need to affix a permanent tracking label to the product and its packaging. The tracking label shall have a Batch ID, with the following information:

  •   SKU
  •   Manufacturing date
  •   Production facility
  •   Example: SKU-YYMM-01

Notice: Tracking labels are not mandatory for all products. However, we strongly recommend you to have one attached.

c. Document Requirements

Test Report

Sample test report issued by SGS

Test reports are issued by third party inspection companies, such as QIMA or Intertek. 

As explained, you should not reuse an existing supplier test report.

d. Laboratory Testing Requirements

Lab testing is not mandatory for most of non-children’s products. However, the customs authorities and other government and/or state bodies, retailers and marketplaces (i.e., Amazon.com) may request test reports proving compliance with all applicable product standards or regulations.

Further, obtaining a test report is the only way to verify that your products are compliant with all applicable regulations. 

A test report can be obtained from a third party testing company (i.e., Asiainspection or SGS), and is valid for a specific chemical, regulation or standard (i.e., Lead, CA Prop 65 or ASTM F963).

To be on the safe side, we strongly advise you to create a testing plan and submit your products for lab testing (see Tutorial 4.5).

Get a Free Lab Test Quote

QIMA is an accredited testing company, based in Hong Kong. Click on the button to request a free quote for REACH, CA Prop 65, CPSIA, RoHS and other tests.

e. Additional Resources

The content provided in this guide is exclusively for an informational purpose, and shall not be relied upon as always accurate or up to date. Product regulations can change at any time. 

As such, it is critical that you contact the authorities in your market, to confirm all applicable requirements.

  •   Product Safety Australia (Link)
  •   Standards Australia (Link)
  •   Product Bans (Link)
  •   Home Affairs: Importing prohibited and restricted goods (Link)
  •   Australia Product Labeling Requirements (Link)

f. Other Information

  •   Additional regulations may apply in your state. Contact your local authorities to confirm if any additional regulations or substance bans are in place.

Very few manufacturers in Asia are aware of NS/NZS standards. You must refer to specific technical details outlined in the standards file when communicating with suppliers, rather than referring to the NS/NZS standards title or number.

 

Compliance Assessment

 

This tutorial is a roadmap helping you assess mandatory product regulations, standards, substance regulations, labeling, documentation, and other requirements.

Checklist 1: Product Regulations

 Is one or more product-specific product regulations applicable to the product?

 Is one or more mandatory product standards applicable to the product?

 Is one or more voluntary product standards applicable to the product?

 Is one or more substance regulations applicable to the product?

 Is one or more regulations applicable to the product packaging?

Read this

  1. Please see Tutorial 6.3 for more information about relevant product regulations, standards, and general requirements. Note that additional regulations, standards, rules, and requirements (not covered in 6.3) may apply.
  2. Lab testing companies, such as QIMA and Intertek, can help you confirm currently applicable (mandatory and voluntary) product standards and regulations when you request a free lab testing quotation.
  3. Product regulations, standards, and other requirements are subject to updates and changes, and new regulations may be added. 

Note that lab testing companies, such as QIMA and Intertek, generally keep track of new regulations, standards, and other requirements.

  1. You must contact all relevant national/state authorities (see Additional Resources for examples) to request information on applicable product regulations, standards, and other requirements. 

Note that we don’t guarantee that Tutorial 6.3 is kept up to date or is entirely accurate.

  1. Products of any type or category designed for children are generally subject to mandatory children’s product safety standards.
  2. Product regulations may cover safety standards, documentation/certification requirements, labeling, packaging, and testing requirements.

Tips

USA: The CPSC Small Business Ombudsman can help you confirm applicable product regulations and requirements. We also recommend that you contact them to get a second opinion, and to confirm the current CPSIA requirements which are subject to change.

EU: Buy a requirements list from www.productip.com

Checklist 2: Product Safety

Apply this assessment to each applicable product regulation/standards.

 Confirm how the relevant standards impact the following aspects of the product:

  •   Product design
  •   Materials
  •   Physical/mechanical properties
  •   Safety aspects
  •   Packaging

 

Checklist 3: Labeling Requirements

 Which labeling requirements apply to the product?

 Which labeling requirements apply to the packaging?

 Do you need to affix a warning label?

 Do you need to affix a country of origin label?

 Do you need to affix a compliance mark?

 Do you need to affix a tracking label/traceability label?

 

Checklist 4: Documentation/Certification Requirements

Are there any mandatory document requirements for your product?

 Which information must be specified on the document/s?

 Do we need to create a user manual? (If Yes: Confirm the contents list)

 Can the document/s be self-issued by the Importer or is an accredited third party required?

 Is the Importer required to submit pre-production and/or pre-delivery documents to a government agency or other parties for approval or review?

 

Checklist 5: Testing Requirements

 Is third party laboratory testing mandatory?

 Must lab testing be carried out by an accredited testing company?

 Task List

Follow this process once you have confirmed all applicable product regulations, standards, and other requirements for your products in your target country/market.

Task 1: Product Regulations/Standards

 Confirm applicable mandatory product regulations/standards

  •   Step A: Review Tutorial 6.3
  •   Step B: Review Additional Resources
  •   Step C: Contact relevant authorities
  •   Step D: Request lab test quote and assessment (Link)

 Confirm applicable voluntary product standards

 Confirm applicable substance regulations

 Confirm applicable packaging regulations

 Adjust product design, components and/or materials to comply with applicable product regulations and standards

 Inform your manufacturer of all relevant product regulations, standards, and other compliance requirements

 Optional: Submit a pre-production sample for compliance testing

Read this

  1. Please see Tutorial 6.3 for more information about relevant product regulations, standards, and general requirements. Note that additional regulations, standards, rules, and requirements (not covered in 6.3) may apply.
  2. Lab testing companies, such as QIMA and Intertek, can help you confirm currently applicable (mandatory and voluntary) product standards and regulations when you request a free lab testing quotation.
  3. Product regulations, standards, and other requirements are subject to updates and changes, and new regulations may be added. 

Note that lab testing companies, such as QIMA and Intertek, generally keep track of new regulations, standards, and other requirements.

  1. You must contact all relevant national/state authorities (see Additional Resources for examples) to request information on applicable product regulations, standards, and other requirements. 

Note that we don’t guarantee that Tutorial 6.3 is kept up to date or is entirely accurate.

  1. Products of any type or category designed for children are generally subject to mandatory children’s product safety standards.
  2. Product regulations may cover safety standards, documentation/certification requirements, labeling, packaging, and testing requirements.

Tips

USA: The CPSC Small Business Ombudsman can help you confirm applicable product regulations and requirements. 

We also recommend that you contact them to get a second opinion, and to confirm the current CPSIA requirements which are subject to change.

EU: Buy a requirements list from www.productip.com

 

Task 2: Create Label Files

 Create product label files (.ai or .eps)

 Create packaging label files (.ai or .eps)

 Submit label and/or packaging files to your supplier

Task 3: Documentation/Certification

 Create self-issued product certificates (If applicable)

 Create technical file (If applicable)

 Create user manual (If applicable)

 Apply for pre-import approval/permit (if applicable)

Task 4: Book Lab Testing

 Request third-party lab testing quotation

 Submit product and packaging to the third-party testing company

 Obtain product lab test report

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