Product compliance refers to a set of regulatory requirements, guidelines, and benchmarks that a product must adhere to for lawful market placement. These stipulations vary depending on the product type and market, covering diverse facets like electrical safety, electromagnetic compatibility, radio frequency, chemical composition, eco-design, energy efficiency, mechanical safety, restrictions on hazardous substances, child safety, artificial intelligence, cybersecurity, safety labeling, consumer information, packaging, and extended producer responsibility. Navigating product compliance is intricate, requiring manufacturers to possess a comprehensive grasp of its multifaceted components to avoid costly errors.

Frequently, distinct laws govern specific product aspects. Therefore, ensuring your product’s compliance involves understanding not just one regulation but potentially multiple. In the EU, well-known product laws include the Radio Equipment Directive (RED), Low Voltage Directive (LVD), Restrictions on Hazardous Substances (RoHS), Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Waste of Electrical and Electronic Equipment (WEEE), and General Product Safety Directive (GPSD), among others. The U.S. also employs abbreviations like the Consumer Product Safety Act (CPSA), Toxic Substances Control Act (TSCA), and California Proposition 65 (Cal Prop 65). Moreover, every country has its distinct regulations and acronyms.

Scope

Countries have the autonomy to select the product aspects they wish to safeguard through regulatory requirements and determine the applicable product categories. While most nations globally regulate electrical household appliances and radio devices, the specific categories of regulated products can vary significantly across markets. Commonly regulated goods encompass machinery, toys, vehicles and their components, medical devices, personal protective equipment, construction products, equipment for potentially explosive atmospheres, and laboratory equipment—categories generally deemed safety-relevant. Nevertheless, each country independently decides which products are safety-relevant and necessitate conformity assessments.

Likewise, the approaches for substantiating a product’s compliance with regulatory prerequisites can vary among countries. Among the most prevalent conformity assessment procedures/schemes are:

1. Self-certification/declaration of conformity: In this scenario, the product manufacturer assumes exclusive responsibility for ensuring compliance with regulatory requirements and standards. While optional, the manufacturer may choose to have the product tested by a third party. The manufacturer may issue a declaration of conformity, affirming the product’s adherence to applicable laws and standards. This method is termed a first-party conformity assessment.
2. Registration: Manufacturers may be obliged to register their products with a designated authority before importation or sale.
3. Third-party testing: Manufacturers must enlist an independent accredited body to conduct official testing and provide test results.
4. Certification: In this process, the product undergoes testing by an independent body and is required to obtain an official certificate based on the test results.

This list is not exhaustive, and additional requirements such as factory inspections or certification of quality management systems (ensuring production conformity) may complement the mentioned procedures. These procedures can coexist within a single country and may be applicable to various product categories.

Additionally, there is a second-party conformity assessment for products. This involves clients wanting to conduct their own testing on products before purchasing. Typically, this is prevalent among significant or discerning customers like governments or major buyers. The second-party assessment is not mandated by public law but arises from contractual agreements with the purchasing party.

An inherent aspect of product compliance includes the presence of compliance labels or markings. While consumers typically do not delve into product regulations, technical standards, or the intricacies of test and certification procedures, they commonly encounter various signs and symbols displayed on product or package labels. Among these symbols, European consumers frequently come across the letters “CE,” denoting “Conformité Européenne” in French (or European Conformity in English). However, other countries opt for more intricate designs, occasionally resembling Egyptian hieroglyphs. Worldwide, there is a multitude of national compliance markings – just look at any electrical device you have,

As indicated at the outset of the article, the initial purpose behind the inception of product compliance was primarily to safeguard consumers from hazardous products. However, nations swiftly realized that product compliance could also function as a trade barrier, serving as a tool to safeguard their domestic markets. Requirements like having a local representative, conducting in-country testing, or adhering to national technical standards can obstruct the importation of goods and substantially escalate associated costs. While certain obligations, such as having a local representative for addressing issues, may be justifiable, others, like the need for duplicate testing according to identical standards, can be perceived as purely economically burdensome.

Technical barriers to trade (referred to as TBTs) associated with product compliance requirements serve as a valuable tool for states for an additional reason. Average tariff rates worldwide have been on a decline for several decades as part of global trade liberalization, diminishing their efficacy as a protectionist measure. In contrast, technical barriers to trade are more challenging to identify and challenge, often being justified under the guise of product safety or consumer protection.

Illustrative Approaches to Product Conformity

To exemplify the diverse ways in which different countries approach and regulate product conformity, a selection of examples from major markets can be informative. The brief descriptions provided below aim to offer readers a broad overview and basic understanding, avoiding excessive details for simplicity. For a more in-depth perspective, readers are encouraged to reach out directly to the author of this article.

Within the European Union, the primary framework for CE conformity assessment revolves around the CE declaration of conformity (DoC). This document serves as the manufacturer’s declaration regarding which EU product directives their product aligns with. With over 20 CE directives covering various product groups like low voltage equipment, radio devices, lifts, toys, and more (some of which were mentioned earlier in the article), the manufacturer also specifies the harmonized standards the product adheres to. These standards, published in the Official Journal of the EU, presume conformity with the essential requirements of EU product directives. It is essential for the manufacturer to ensure that the product genuinely meets all the stipulated requirements, not just declare it. However, in most cases, legal obligations do not mandate the involvement of a third-party testing body or the issuance of an official product certificate.

The EU declaration of conformity represents one of the concluding steps in the comprehensive process. Initially, before introducing the product to the EU market, the manufacturer identifies the applicable EU directives. There are no official lists of products covered by CE conformity; the manufacturer assesses applicability based on often ambiguous definitions within the directives. From the applicable directive(s), the manufacturer derives product-specific requirements and determines an appropriate route for conformity. Subsequently, the technical documentation is compiled, the CE declaration of conformity is issued, and the product is marked with the CE symbol.

Remarkably, this standardized approach to product regulation within the EU has not always been the norm. Only in the past 10-15 years, as part of the single market creation, were product requirements and standards harmonized. In previous times, significant trade barriers existed among EU members, each country possessing its own conformity marking (imagine over 20 pictograms on electrical plugs designed solely for the European market). The recent introduction of the British product label UKCA, coupled with legislative complexities due to Brexit, provides insight into the pre-harmonization era of Europe.

The Chinese CCC certification (China Compulsory Certification) shares some similarities with the EU system, yet significant differences exist. Similar to the EU, China has a structured and comprehensive conformity assessment system with regulations tailored to specific product groups and a national conformity label (there is even an official catalog of affected products). However, the two pivotal elements of CCC certification, which also differentiate it from the European CE system, involve mandatory in-country product testing (requiring many certified products to undergo testing in Chinese laboratories) and factory audits (delegations of Chinese auditors inspecting the manufacturing sites of product producers). Following successful completion of tests and audits, products receive a CCC certificate.

Lately, China has been incorporating certain aspects of the system based on manufacturers’ declarations of conformity, akin to the EU. The concept of the CCC Declaration of Conformity has been expanded to encompass an increasing number of product groups.

The philosophy surrounding product compliance in the United States significantly differs from that in Europe or China. Unlike these regions, there is no universally endorsed, government-backed conformity assessment scheme covering all products. The absence of lists detailing product regulations or catalogs of regulated products is notable. In fact, only a limited number of product categories are legally obligated to undergo conformity assessment, as exemplified by radio transmitters necessitating FCC approval. Similarly, there is no national compliance marking equivalent to the European CE or the Chinese CCC. However, this absence does not imply a lack of regulations in the USA.

The impetus for product testing often arises from the market and client demands. Several private testing and certification schemes exist for various product categories, with the most prominent being UL, also known as Underwriters Laboratories. Certification from such entities may be mandated by American business partners, facilitate product marketing by instilling consumer trust, and provide assurance that the product is secure and aligns with American standards.

What about the rest of the world? There is a spectrum of diverse approaches, ranging from stringent conformity assessment systems mandating in-country certifications to a complete absence of conformity assessments (with various intermediary forms). Among countries with well-organized, universal systems relying on national certifications are, for instance (with system names often derived from national standardization bodies): the Eurasian Economic Union (EAC – Eurasian Conformity), Brazil (INMETRO – Instituto Nacional de Metrologia, Qualidade e Tecnologia), Indonesia (SNI – Indonesian National Standard), India (BIS – Bureau of Indian Standards), South Korea (KC – Korea Certification), Chinese Taipei (BSMI – Bureau of Standards, Metrology and Inspection), Saudi Arabia (SASO – Saudi Standards, Metrology and Quality Organization), the United Arab Emirates (ESMA – Emirates Conformity Assessment Scheme), or Mexico (NOM – Norma Oficial Mexicana).

These systems encompass a variety of product groups (not restricted to a specific category), often requiring a specific national mark on products. They rely on national testing bodies and institutions to conduct certifications. Clearly, the establishment and operation of such systems necessitate a specific testing infrastructure and technical expertise, which not all countries possess. Consequently, many other countries, rather than implementing comprehensive conformity assessment schemes, opt to regulate only a select few product categories, especially those most pertinent to consumer safety, such as electrical household appliances or radio devices.

Another approach, frequently utilized by many African countries, involves outsourcing the conformity assessment of imported products to accredited private companies. Numerous worldwide companies manage the so-called PVoC (pre-export verification of conformity) programs. These programs involve verifying products before export to their destination and issuing certificates allowing for importation (often on a per-shipment basis). One challenge with PVoC programs is the lack of a clear legal foundation publicly detailing the technical requirements and standards that imported products should meet. Such details are often communicated solely through bilateral exchanges with the accredited company, limiting transparency.

What are the primary challenges confronting manufacturers seeking to globally market their products in terms of product compliance? Firstly, the absence of uniform conformity assessment systems worldwide poses a significant hurdle. Each country possesses unique specifications that manufacturers must be aware of beforehand to avoid costly mistakes. Similarly, the range of products subject to regulations varies widely across different markets. The absence of CE marking requirements in the EU, for instance, does not imply that the product is unregulated in countries like China. Determining whether a product is subject to regulation can itself be a challenge, especially when faced with vague or unclear legal definitions. A comprehensive catalog of affected products with HS codes in a given country is advantageous, whereas reliance on ambiguous legal definitions complicates the assessment process.

Another challenge, which ideally should be addressed during the product design phase, pertains to differing technical requirements and standards between countries. Despite international harmonization efforts, such as those by ISO (International Organization for Standardization) or IEC (International Electrotechnical Commission), many countries opt to develop their own standards. Even when international standards are adopted, importers are often compelled to undergo additional national testing procedures, duplicating the same product tests.

Beyond these challenges, manufacturers must contend with the continuously evolving regulatory landscape. Countries regularly introduce new laws with fresh technical, certification, labeling, and import requirements for various products. New conformity assessment systems emerge, and existing ones undergo modifications. The product scopes affected by regulations are subject to regular changes. Without ongoing monitoring of new requirements and timely analysis of regulations impacting their products, manufacturers risk falling out of compliance, potentially jeopardizing their ability to supply foreign markets. The question arises as to whether manufacturers should allocate resources to handle these intricate tasks and requirements internally or consider outsourcing certain aspects of these activities to trusted experts.