Category: Regulation

[The following is a longer and un-footnoted draft of a fifth Policy Digest prepared for a Sydney Southeast Asia Centre joint research project and an ASEAN Secretariat project on harmonising consumer protection law. It is highly relevant also to Japan in light of Kanebo’s large-scale recall of some of its skin-whitening products across the region as well as in Japan in 2013.]
1. Introduction
Consumer goods associated with higher risks, and often also extent of harm, tend to generate public regulatory interventions. Food is one example, for which nation states have often legislation quite early on. However, national legislation and implementation is increasingly impacted by international law, particularly World Trade Organization (WTO) or bilateral and regional free trade agreements agreements insist that food safety measures be based on rational and proportionate public health risk assessments, and not constitute disguised trade barriers. This is facilitated by such agreements expressly stating such requirements will be presumed to be satisfied if the national measures are based on food standards agreed in the Codex Alimentarius, administered by two United Nations bodies. The Codex process has remained relatively unpoliticised, based instead on scientific risk assessments, partly because most countries both export and import foods but also because food is a necessity for everyone. This backdrop has also made it easier for other international and regional bodies, including ASEAN and APEC, to collaborate with national regulators and the private sector to develop shared food safety standards in Southeast Asia and world-wide.
Pharmaceuticals and, more recently and in a less interventionist way, cosmetics (goods without, necessarily, any medicinal properties) have also tended to generate regulatory regimes at the national level. At the international level, however, the WTO’s 1994 Technical Barriers to Trade (TBT) Agreement does not expressly create a presumption of conformity from adhering to standards set by specified bodies, when national regulators introduce measures applicable to imports. There is no counterpart to the Codex process; different countries and regions maintain more disparate approaches to assessing and regulating non-food sectors, partly because they may not be exporting as much as importing certain types of goods.
Overall, moreover, the United States (US) often adopts more lenient regulatory regimes compared to the European Union (EU). This is particularly noticeable with respect to cosmetics: the US relies much more on voluntary industry self-regulation (plus more threat of private lawsuits for product liability), whereas the EU favours more interventionist public regulation. Nonetheless, the EU’s 1976 Cosmetics Directive aimed to balance consumer protection with harmonized standards to facilitate cross-border trade, especially within and into Europe. Because the regulatory regime remains stricter than in the US, and EU’s cosmetics manufacturers are more likely to sell into the more regulated European markets than American manufacturers, the EU can also support European manufacturers by encouraging countries and regions in other parts of the world to “trade up” to the EU rather than laxer US regulatory approach, when developing their own laws and practices. Already, by 2004, the lists of ingredients set under the 1976 EU Cosmetics Directive had been adopted by 30 countries, including countries in South America party to the Mercosur and Andean Pact regional arrangements. Other countries, including China and India, have reproduced significant features of the EU model.
Furthermore, although this is not widely known, the EU model has been adopted in Southeast Asia through the “Agreement on the ASEAN Harmonized Cosmetics Regulatory Scheme”. This was signed in 2003 to advance the ASEAN Free Trade Area program, albeit also against the backdrop of the WTO’s TBT Agreement. Schedule A creates the ASEAN Mutual Recognition Arrangement of Product Registration Approvals for Cosmetics, allowing individual ASEAN Member States (AMSs) to agree with other AMSs to allow, without further requirements, the import of products that satisfy the regulatory requirements of the other state(s). However, any such mutual recognition agreements (anyway possible under the TBT Agreement) were envisaged as a temporary step towards harmonizing cosmetics regulation in the region. More importantly, under the 2003 Agreement (Art 2(3)) the AMSs committed to implement by 1 January 2008 the “ASEAN Cosmetics Directive” (ACD) set out in Schedule B. This closely tracks the EU Directive, including by requiring the AMSs to “adopt the Cosmetics Ingredients Listings of the EU Cosmetics Directive 76/768/EEC including the latest amendments”. Supported by the ASEAN-EU Programme for Regional Integration Support, by early 2008 six AMSs had started implementing the ASEAN Directive into their national laws, followed by Thailand, Cambodia, Laos and Myanmar a year and half later, and finally Indonesia from 2013. The ACD regime has therefore been described as “one of the first concrete instances of economic integration between ASEAN countries”.
Meanwhile, however, the EU itself replaced its Directive in 2009 with a Cosmetics Regulation, which on 11 July 2013 came into direct effect in the (now 27) EU member states, rather than having to be implemented by national legislation – sometimes not straightforwardly – as occurs when harmonisation is attempted by means of a Directive. The EU Regulation similarly attempts to enhance cross-border trade through harmonisation, expanding consumer choice while respecting public health, for example by adding new requirements to label cosmetics (such as suncreens) that include nano-particles.
Part 2 below therefore takes a closer link at key features of the ACD, including some differences that remain compared to the original EU model (and especially the US regulatory regime), as well as implementation and other challenges. As elaborated in Part 3, as well as various concrete improvements that could be made to this approach for harmonizing consumer product safety law, the model might eventually be extended to other sectors and anyway is relevant to general consumer regulators, even if the primary jurisdiction over cosmetics usually remains with health officials.

Continue reading “Cosmetics regulation under national and ASEAN law”

[The following is a longer and un-footnoted draft of a fourth Policy Digest prepared for a Sydney Southeast Asia Centre joint research project and an ASEAN Secretariat project on harmonising consumer protection law.]
1. Introduction
Public regulation of food safety is typically an early and major priority for law reformers at the national level, given potentially high risks and degrees of harm from unsafe foods. For products that present lower risks, for which it is more difficult to mobilize political resources to regulate, product liability regimes can also incentivise manufacturers to consider food safety – especially if potential harm is extensive, liability is strict, and court systems work effectively. Further incentives can come from reputational effects, in the context of growing (social) media coverage of food safety concerns. Nonetheless, as outlined in Part 2 below, serious food safety failures continue to occur in both developing and developed countries.
General food laws have been enacted in ASEAN Member States (AMSs). As shown in a recent comparison of Indonesia, Malaysia, Thailand and Singapore, they generally impose criminal and/or administrative sanctions for food adulteration, foods injurious to health, food unfit for human consumption, insanitary facilities, and false labeling or deceptive advertising. (Indonesia’s Food Act 1996 further provides specific civil remedies for consumers harmed by unsafe food.) Yet enforcement is problematic: “Food quality and safety standards are usually strictly followed for exportable food commodities, but not always enforced for food destined for the domestic market”.
In addition, such food laws tend to fall under the jurisdiction of ministries of agriculture and/or health. To minimize conflicts of interest, namely agriculture ministries favouring suppliers rather than consumers, there is a tendency to establish independent food agencies, as in the United States (US, although the agriculture department still regulates some products) or Myanmar (within the Health Ministry). This is especially true for risk assessment functions, as in the European Union (EU) since 2002, and Japan since 2003 (for risk management if harm eventuates, Japan’s agriculture ministry still regulates farm safety while the health ministry deals with the subsequent supply chain).
However, other government departments are also increasingly involved in food safety regulation. On the one hand, ministries of commerce or trade get involved because international treaties now require science-based, proportionate regulation of import safety, preferably based on internationally agreed standards, as outlined in Part 3 below. On the other hand, there is existing and potential scope for consumer affairs regulators to become (more) involved in food safety regulation, even though they may constitute smaller and more recently created public authorities, because:
• they often have or share responsibility for enforcing food standards set by other departments (as seen in the Consumer Protection Laws enacted in Vietnam in 2010 and Myanmar in 2013);
• consumer regulators may also be given a coordinating role, or “back-up” powers to regulate if a harmful food product falls outside the jurisdiction of other agencies (eg konnyaku jelly snacks in Japan until the Consumer Affairs Agency was established in 2009);
• consumer regulators may have powers to bring representative actions (as in Thailand) or order compensation (as in Myanmar) on behalf of consumers harmed by non-compliant foods.
Consumer regulators also develop helpful expertise in consumer behaviour and risk communication more generally, which is valuable for law-making related also to food nutrition (i.e. “healthy eating”) – a broader contemporary policy concern than food safety (i.e. avoiding food-borne illnesses). As explained by the Consumers International regional representative at the inaugural ASEAN Consumer Protection Conference, held in Vietnam over 8-9 November 2014, promoting healthy diets is a priority because adverse health effects associated with obesity are now spreading to Southeast Asia. In addition, consumer regulators can assist other government authorities in developing effective schemes for oversight of “food safety auditing” by private inspectors, already widely used in global food supply chains and likely to be further facilitated through international agreements on trade in services, yet potentially creating conflicts of interests for the auditors which may impact adversely on consumers.
Accordingly, there is a need to expand capacity in food-related health issues among consumer regulators in AMSs. They need enhanced opportunities to engage with other national regulators (with shared or primary responsibility for food safety regulation) as well as the growing numbers of international, inter-governmental or public-private partnership organisations involved in generating shared food safety standards in the region. This is especially important given that the ASEAN Economic Community (AEC) project, promoting free trade in goods and services by 2015, includes harmonisation of agri-food standards as a priority action item (as elaborated in Part 3).

Continue reading “Food Safety Regulation under National and International Law: Integrating Consumer Regulators in Proliferating Standardisation Projects”

[The following is an un-footnoted longer draft of one of two Policy Digests prepared for a Sydney Southeast Asia Centre joint research project and an ASEAN Secretariat conference on consumer protection law in Hanoi over 8-9 December 2014. The footnoted final version is available at: http://www.asean.org/resources/publications/item/consumer-protection-digests-and-case-studies-a-policy-guide-volume-1?category_id=382]
1. Overview
Consumer product safety is a major contemporary concern for developing, middle-income and developed economies. ASEAN, through its Committee on Consumer Protection (ACCP), has recognised this as a priority topic for international collaboration, as trade in goods accelerates through the region with its major trading partners world-wide. Part 2 of this Digest highlights the policy challenge. Part 3 shows how market and even private law incentives are unlikely to provide sufficient incentives for manufacturers to produce safe products; some minimum regulatory standards are needed. Part 4 focuses on regulatory powers to force recalls of unsafe goods, but also requirements for suppliers to notify national regulators about ‘voluntary’ recalls. It also outlines recall information disclosure efforts underway nationally, regionally (notably within the European Union, EU, but also through ACCP since early 2011), and now internationally (especially through the Organization for Economic Cooperation and Development, OECD, since late 2012). This Digest suggests there is scope already for greater engagement by ACCP and individual ASEAN member states particularly with the OECD initiative in this field. Part 5 also urges broader information-sharing as the OECD clearing-house expands over the next few years, as well as with product safety incident reporting systems already developed particularly in the EU and the United States (US).

Continue reading “Consumer Product Safety Regulation – Recalls and Accident Information Disclosure Mechanisms”