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A Look at the Toxic-Free Cosmetics Act

If signed by the Governor of California, the Toxic-Free Cosmetics Act, Assembly Bill (A.B.) 2762 would become the first law in the United States to ban 12 ingredients from beauty and personal care products sold in the state due to toxicity concerns.

Proponents of the act say that existing state regulations fall short when it comes to prohibiting toxic chemical additives. There is a paucity of beauty and personal care product regulations on the federal level as well – of more than 10,000 chemicals used to formulate these products, the federal Food and Drug Administration (FDA) prohibits or restricts only 11. The European Union prohibits or restricts nearly 1,400.

Prohibiting the sale of cosmetic products with the specified chemical ingredients could protect consumers against exposure to harmful chemicals in the cosmetic products they use every day.

Current Law Governing Cosmetics

Two existing state laws govern cosmetics – the Sherman Food, Drug and Cosmetic Law (“Sherman Law”) and the California Safe Cosmetics Act of 2005 (“Safe Cosmetics Act”). Sherman Law prohibits the manufacture, sale, delivery or holding of adulterated cosmetics. It also prohibits the adulteration of any cosmetic. The California Department of Public Health (CDPH) administers Sherman Law.

The Safe Cosmetics Act requires manufacturers to submit a list of all cosmetics sold in the state that contain any chemical ingredient indentified as causing cancer or reproductive toxicity. CDPH maintains an active, searchable database that contains all the data collected from manufacturers under the Cosmetics Act. So far, more than 600 companies have reported more than 75,000 products.

On a federal level, the Food, Drug and Cosmetic Act (FD&C Act) requires cosmetics produced or distributed for retail sale for personal care must bear a label with the product’s ingredients.

Proposed Law Bans 12 Ingredients

The Toxic-Free Cosmetics Act aims to ban the intentional addition of 12 ingredients to cosmetic products sold in California. These ingredients are:

• Mercury
• Formaldehyde
• Paraformaldehyde
• Dibutyl phthalate
• Diethylhexyl phthalate
• Methylene glycol
• Isobutylparaben
• Isopropylparaben
• Quaternium-15
• m-Phenylenediamine and its salts
• o-Phenylenediamine and its salts
• Specified long-chain per- and polyfluoroalkyl substances (PFAS) and their salts

These 12 ingredients are known carcinogens, reproductive toxicants, and endocrine disruptors. The European Union has already banned these ingredients.

The proposed law provides an exception for products made with the intention to comply with the law, but that contains an unavoidable and trace amount of one of the 12 ingredients, and that the trace quantity is the result of impurities in the ingredients, the manufacturing process, migration from product packaging, or storage.

Purpose of the Toxic-Free Cosmetics Act

The authors of the Toxic-Free Cosmetics Act hope the legislation will address a number of policy issues, such as filling in regulatory gaps in cosmetic safety. Neither the FDA nor the CDPH require safety testing, review, or approval of cosmetic products before they hit the market. Furthermore, state and federal laws do not require approval of cosmetics and their ingredients prior to sale to the public. In fact, the FDA does not even have the authority to require manufacturers to file health and safety data on the ingredients they use in cosmetics, or to order a recall of harmful cosmetic products.

If enacted, the new law would also address public health concerns. Adults and children use cosmetic products every day of their lives. During the course of normal beauty and cleansing routines, consumers apply these products to their faces, eyelids, lips, and other sensitive areas of the body. Ensuring the safety of these products is essential to the health and well-being of all those who use cosmetics.

This legislation would also get California law up to speed with European Union regulations, which already create uniform safety standards for the cosmetics sold there.

Implications of COVID-19

California lawmakers introduced the original bill in February 2019, long before the coronavirus disease 2019 (COVID-19) pandemic began. Legislators approved amendments to give manufacturers and governing bodies more latitude in implementing some of the changes. The original bill included an effective date of January 1, 2022, for example, but lawmakers pushed the effective date to January 1, 2025. This change reflects the profound effect the pandemic has had on companies, particularly those that suffered slowdowns or that refitted their operations to increase production of disinfectants.

Amendments also prevent CDPH from prohibiting chemicals not appearing on that list of 12; the original bill contained a provision that allowed CDPH to identify chemicals to potentially ban. While the California Assembly recognized that exposure to toxic chemicals can cause harm, they found that the extra duty of identifying chemicals might cause unnecessary pressure on CDPH during the pandemic.

State of Play

The California legislature passed the Toxic-Free Cosmetics Act on Monday, August 31, 2020 and sent the act to California Governor, Gavin Newsome.

Key Components of the PFAs Action Act

Per- or polyfluoroalkyl substances (PFAS) can improve the quality of some products, but these substances can cause harm to human health and the environment. A new act, known as the PFAS Action Act of 2019, aims to regulate the use of PFAS in manufacturing.

PFAS are a group of nearly 5,000 chemicals that reduce friction and improve a resistance to grease, stains and water, and reduce friction in a wide variety of materials and products. A number of household items, such as cookware, food packaging, carpets, sofas and clothing can contain PFAS. Several industries use PFAS, including aerospace and paper production.

Manufacturers prize PFAS for the chemicals’ strength and stability, but this strength and stability also allow PFAS to linger in the atmosphere. PFAS can also accumulate in the body in a process known as bioaccumulation. Some manufacturers have argued that bioaccumulation occurs only with the older, “long-chain” PFAS and not with the newer short-chain PFAS, but both types of PFAS are toxic. Research links PFAS with elevated cholesterol levels, cancer, immunological effects, thyroid hormone disruption, and low infant birth weights.

The U.S. House of Representatives passed legislation to require regulation of PFAS on January 10, 2020. Titled the PFAS Action Act of 2019, the bill requires the Environmental Protection Agency (EPA) to consider PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980. Amending several existing laws, the PFAS Action Act of 2019 contains key components that provide both short-term solutions and long-term strategies to address the important human health and environmental issues associated with PFAS.

PFAS Action Act of 2019 – Key Changes Manufacturers Need to Know

The bill attempts to remedy the lack of federal PFAS regulation by amending The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). It would give the EPA a year to designate PFOA and PFOS as hazardous substances, and five years to determine if CERCLA should designate all PFAS chemicals as hazardous substances. If enacted, it would extend CERCLA’s coverage to new sites and trigger the reevaluation of sites where cleanup is ongoing and sites that have already completed cleanup.

The Toxic Substances Control Act (TSCA) prompts the creation of new EPA rules requiring comprehensive toxicity testing on all PFAS. Section 2 of the PFAS Action Act designates certain PFAS as hazardous substances, a classification that requires the immediate remediation to the release of these chemicals into the environment. It also gives the EPA five years to determine if the other PFAS should be classified as hazardous.

The bill would amend the Safe Drinking Water Act (SDWA), which requires that a primary drinking water regulation for a contaminant must include a maximum contaminant level (MCL). Amending the SDWA would require the EPA to set a drinking water MCL for two of the most well-known and prevalent PFAS chemicals, PFOA and PFOS. It also allows the EPA to reach informed conclusions about the health risks imposed by all classes of PFAS by examining information about single chemicals within the group, which relieves the EPA of the burden of evaluating each PFAS chemical individually. Furthermore, it would require primary drinking water regulation be protective of the health of at-risk populations, such as infants, pregnant women, and the elderly.

The bill would amend the Clean Air Act (CAA), which requires the EPA to maintain and update a list of hazardous air pollutants, identify and categorize the sources of the pollutants, and establish emission standards for each category. The amendment would require the EPA to include PFOS and PFOA in the list of hazardous air pollutants and create stringent emission standards for the sources of those chemicals.

The PFAS Action Act would also amend the Clean Water Act (CWA) by adding a requirement that the EPA complete plans providing for the reviews of the PFAS for each class of PFAS discharged from sources outside of publicly owned treatment works. The reviews would help determine whether to add a PFAS to the CWA’s Toxic Pollutants list and if establishing limitations or standards for each PFAS is necessary. The bill would allow agency discretions as to whether to include certain classes of PFAS on that list, and whether limitations pretreatment standards should control the discharge of those chemicals. The amendment to the CWA would also require the EPA to issue human health water quality criteria within two years for measurable PFAS.

The bill would amend the Solid Waste Disposal Act to require incineration of materials containing PFAS in ways that eliminate the toxic chemicals while minimizing the emission of the toxins into the air, and authorize the EPA to approve or develop labels identifying PFAS-free products. It would also require the EPA to work with the U.S. Fire Administration and the Federal Aviation Commission to minimize utilization if and contact with firefighting foam without jeopardizing firefighting efforts.

In short, enacting the bill would cause PFAS to go from being nearly unregulated by federal law to strict regulation under a number of prominent federal environmental protection laws.

 

As a leader in Consumer Product Testing, Eurofins keeps our customers up to date on the latest regulations to ensure compliance. To learn more about our services, contact us today.

 

How to Ensure Personal Protective Equipment is Safe and Effective

 

Manufacturers typically maintain a steady supply of personal protective equipment (PPE) to keep healthcare workers and patients safe. The COVID-19 outbreak caused a significant shortage of PPE, however, leaving hospitals and other organizations scrambling to find the surgical masks, N95 respirators, medical gowns, and gloves they needed. A number of manufacturers expanded or switched their operations to fill the void. While PPE production had to be swift, the products also had to be safe and effective against the spread of coronavirus disease.

Ensuring the safety and effectiveness of PPE is important – lives depend on it. But how can manufacturers ensure that the PPE they provide is safe and effective?

How to Ensure the Safety and Effectiveness of PPE

Adhere to FDA regulations

The U.S. Food & Drug Administration (FDA) sets regulations for all PPE intended for use as a medical device. The agency also provides device-specific guidance for some products to help PPE manufacturers comply with FDA expectations. The FDA reviews some PPEs before allowing their sale on the U.S. market.

Following the FDA’s regulations and practices provides reasonable assurance of the PPE’s safety and effectiveness. PPE should also meet voluntary consensus standards. Both consensus standards and FDA requirements vary depending on the specific type of PPE. Adhering to these standards provides reasonable assurance that PPE is safe and effective.

The FDA’s Quality Systems Regulations and Good Manufacturing Practices help ensure the safety and effectiveness of PPE. The administration expects manufacturers to use the regulations and practices to maintain consistent product quality. The regulations and practices should also guide manufacturer’s performance testing to ensure all PPE meet recognized consensus standards. Standards for PPE may include filtering capacity, fluid resistance, leak protection, and resistance to snags and tears.

The Premarket Notification 501(k) clearance requires manufacturers to demonstrate that their products meet specific criteria for performance, labeling, and intended use to show substantial equivalence to existing products. Manufacturers may demonstrate substantial equivalence in a number of ways. They might conform to consensus standards for barrier performance and resistance to snag and tears, for example. PPE makers might also use voluntary consensus standards to demonstrate sterility when applicable, fluid resistance, biocompatibility, and flammability. To gain clearance, makers of PPE must validate the methods they use to test conformance to standards. They must also provide the appropriate performance test data to support each product.

PPE during COVID-19

The FDA issued two documents providing guidance for PPE during the COVID-19 public health crisis: FDA Guidance for Industry (April 2020) Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised), and FDA Guidance for Industry (March 2020) Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency.

The temporary policies outlined in the guidance documents help expand availability of PPE and surgical apparel for healthcare professionals for the duration of the coronavirus outbreak as declared by the Department of Health and Human Services (HHS).

Consumer product testing

Consumer product testing helps PPE makers verify the safety and effectiveness of their products. Testing also helps build consumer confidence in the products offered by a PPE manufacturer.

Consumer product testing evaluates PPE and apparel to the industry standards for safety and effectiveness. Testing for surgical masks ensures the products meet liquid barrier performance outlined in ASTM F186211 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood, for example, and that the product meets Class I or Class II flammability requirement set by 16 CFR 1610.

For more information on consumer product testing for PPE, contact Eurofins Consumer Product Testing. We provide testing, inspection and certification of PPE products and devices to help researchers, healthcare and pharma industries keep people all around the world healthy and safe during the fight against coronavirus.

Key Components of the PFAS Action Act  

 

Per- or polyfluoroalkyl substances (PFAS) can improve the quality of some products, but these substances can cause harm to human health and the environment. A new act, known as the PFAS Action Act of 2019, aims to regulate the use of PFAS in manufacturing.

PFAS are a group of nearly 5,000 chemicals that reduce friction and improve a resistance to grease, stains and water, and reduce friction in a wide variety of materials and products. A number of household items, such as cookware, food packaging, carpets, sofas and clothing can contain PFAS. Several industries use PFAS, including aerospace and paper production.

Manufacturers prize PFAS for the chemicals’ strength and stability, but this strength and stability also allow PFAS to linger in the atmosphere. PFAS can also accumulate in the body in a process known as bioaccumulation. Some manufacturers have argued that bioaccumulation occurs only with the older, “long-chain” PFAS and not with the newer short-chain PFAS, but both types of PFAS are toxic. Research links PFAS with elevated cholesterol levels, cancer, immunological effects, thyroid hormone disruption, and low infant birth weights.

The U.S. House of Representatives passed legislation to require regulation of PFAS on January 10, 2020. Titled the PFAS Action Act of 2019, the bill requires the Environmental Protection Agency (EPA) to consider PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980. Amending several existing laws, the PFAS Action Act of 2019 contains key components that provide both short-term solutions and long-term strategies to address the important human health and environmental issues associated with PFAS.

PFAS Action Act of 2019 – Key Changes Manufacturers Need to Know

The bill attempts to remedy the lack of federal PFAS regulation by amending The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). It would give the EPA a year to designate PFOA and PFOS as hazardous substances, and five years to determine if CERCLA should designate all PFAS chemicals as hazardous substances. If enacted, it would extend CERCLA’s coverage to new sites and trigger the reevaluation of sites where cleanup is ongoing and sites that have already completed cleanup.

The Toxic Substances Control Act (TSCA) prompts the creation of new EPA rules requiring comprehensive toxicity testing on all PFAS. Section 2 of the PFAS Action Act designates certain PFAS as hazardous substances, a classification that requires the immediate remediation to the release of these chemicals into the environment. It also gives the EPA five years to determine if the other PFAS should be classified as hazardous.

The bill would amend the Safe Drinking Water Act (SDWA), which requires that a primary drinking water regulation for a contaminant must include a maximum contaminant level (MCL). Amending the SDWA would require the EPA to set a drinking water MCL for two of the most well-known and prevalent PFAS chemicals, PFOA and PFOS. It also allows the EPA to reach informed conclusions about the health risks imposed by all classes of PFAS by examining information about single chemicals within the group, which relieves the EPA of the burden of evaluating each PFAS chemical individually. Furthermore, it would require primary drinking water regulation be protective of the health of at-risk populations, such as infants, pregnant women, and the elderly.

The bill would amend the Clean Air Act (CAA), which requires the EPA to maintain and update a list of hazardous air pollutants, identify and categorize the sources of the pollutants, and establish emission standards for each category. The amendment would require the EPA to include PFOS and PFOA in the list of hazardous air pollutants and create stringent emission standards for the sources of those chemicals.

The PFAS Action Act would also amend the Clean Water Act (CWA) by adding a requirement that the EPA complete plans providing for the reviews of the PFAS for each class of PFAS discharged from sources outside of publicly owned treatment works. The reviews would help determine whether to add a PFAS to the CWA’s Toxic Pollutants list and if establishing limitations or standards for each PFAS is necessary. The bill would allow agency discretions as to whether to include certain classes of PFAS on that list, and whether limitations pretreatment standards should control the discharge of those chemicals. The amendment to the CWA would also require the EPA to issue human health water quality criteria within two years for measurable PFAS.

The bill would amend the Solid Waste Disposal Act to require incineration of materials containing PFAS in ways that eliminate the toxic chemicals while minimizing the emission of the toxins into the air, and authorize the EPA to approve or develop labels identifying PFAS-free products. It would also require the EPA to work with the U.S. Fire Administration and the Federal Aviation Commission to minimize utilization if and contact with firefighting foam without jeopardizing firefighting efforts.

In short, enacting the bill would cause PFAS to go from being nearly unregulated by federal law to strict regulation under a number of prominent federal environmental protection laws.

 

As a leader in Consumer Product Testing, Eurofins keeps our customers up to date on the latest regulations to ensure compliance. To learn more about our services, contact us today.

 

 

Toxic Chemicals of Concern in Food Contact Material Testing

When a consumer opens a bag of chips or can of soda, they probably have some knowledge of the chemicals and nutrients in their snacks or beverages; they may know less about the chemical that may be present in the bag or can. Many consumers do not realize that packaging and other food contact materials may contain harmful or even toxic chemicals.

Food contacts a variety of materials during its production, processing, storage, preparation, and service. A number of materials and articles, known as food contact materials, are made specifically to come into contact with food. Food contact materials can include packaging and containers, kitchen equipment, dishes and cutlery; they are often made from plastics, rubber, paper, metal, or a combination of materials.

While the majority of food contact materials are stable and safe, chemicals can leach from packaging into food and beverages. In some cases, these chemicals can be hazardous to human health.

Effects of Food Contact Chemicals on Human Health

In March of 2020, an international group of 33 scientists published a peer-reviewed consensus statement in which they urged decision-makers to reduce exposure to harmful chemicals present in food packaging and other materials making contact with food. The consensus statement highlights seven ways to reduce exposure to harmful chemicals in food and food contact materials:

1. Eliminating hazardous chemicals in food contact articles
2. Developing of safer alternatives
3. Modernizing risk assessment
4. Considering the potential endocrine disruption effects
5. Addressing mixture toxicity
6. Improving enforcement
7. Establishing a dialogue between stakeholders to find practical solutions

The group of scientists analyzed lists of food contact chemicals (FCCs) issued by the food industry, governments, and non-governmental organizations (NGOs) worldwide. They found that there are nearly 12,000 chemicals potentially in use in the manufacture of food contact materials; the authors of the consensus statement also found that many of these chemicals have not undergone adequate toxicity testing.

Many FCCs have undergone intense scrutiny and testing. Research has provided great insight into the health risks of exposure to bisphenol A (BPA) and phthalates, for example, which can act as endocrine disruptors and play a role in the development of certain types of cancer. Research shows that other intentionally added substances in food contact materials can have adverse health effects. Ortho-phthalates, found primarily in plastics but also in printing inks, can cause a variety of health problems, such as endocrine disruption, developmental and reproductive toxicity. The anti-static agent in dry food and food handling equipment, perchlorate, disrupts the function of the thyroid gland and reduces production of the thyroid hormone needed for healthy brain development in fetuses and children. The food contamination from these chemicals is widespread; the Food & Drug Administration (FDA) is currently reviewing the safety of these chemicals.

The FDA is acting to reduce or ban other toxic chemicals in food contact materials. The FDA has banned the use of benzophenone as a flavor and in food packaging, citing the carcinogenic evidence regarding the chemical. Used as a plasticizer in reusable rubber articles, as a flavor agent, and in the manufacture of insecticides and agricultural chemicals, benzophenone has been shown to increase the risk of cancer in lab animals.

Not as much is known about many of the 12,000 chemicals cited in the consensus statement, even though information about their hazardous properties and levels of exposure are essential for determining their potential risk to human health.

The authors of the consensus statement also note that there are an unknown, but presumably higher number of non-intentionally added substances (NIAS) finding their way into food packaging, and eventually into food. These substances may include contaminants and the degradation products that can develop during the manufacturing process. Food packaging made from recycled materials is at special risk for the presence of NIAS because the contaminants originate from the recycled material.

Consumers want convenient and visually appealing food packaging, but they want safer food too. By ensuring food contact materials are free from toxic chemicals, companies can improve trust and minimize the financial and operational effects of future regulations.

As a leader in Consumer Product Testing, Eurofins keeps our customers up to date on the latest regulations to ensure compliance. To learn more about our services, contact us today.

 

About Toxic Heavy Metals and the Consumer Products that Contain Them

Toxic heavy metals are everywhere – and they can have a profoundly negative effect on human health.

Heavy metals are metallic elements that are relatively high in density compared to water. Specifically, the density of a heavy metal is at least 5 times greater than that of water.

Some heavy metals, such as antimony, arsenic, beryllium, cadmium, chromium, cobalt, lead, mercury, and nickel, are associated with a high degree of toxicity and therefore pose a significant hazard to human health. These metallic components are systemic toxicants, in that they can induce damage in multiple organs – even at very low exposures.

Their extensive use in industrial, domestic, agricultural, medical and technological applications has led to widespread distribution of heavy metals in the environment. Heavy metals may be present in a number of consumer products, such as televisions, paints, costume jewelry, electronics, lipstick, batteries and ceramics. Exposure is usually through absorption in the intestine, absorption through the skin, or by inhalation.

Research links exposure to metallic compounds in air, water or consumer products to cancer, developmental disorders, and a number of other health problems and diseases.

Types of Heavy Metals and their Effects on Human Health

Antimony

Antimony is a silvery-white metal present in the earth’s crust. This heavy metal is present in or used in the making of many products, such as toys, clothing, pigments, paints, batteries, textiles, plastics, ceramics, enamels and pewter. Exposure to this heavy metal can cause heart problems and respiratory/lung symptoms, reproductive disorders, skin irritations, kidney problems, and stomach problems.

Arsenic

Phased out in many products, such as wood preservatives, arsenic is still used in silicone-based computer chips, certain pesticides, the manufacture of glass, drugs and as a poultry and swine feed additive. Air, cigarette smoke, drinking water, and food can also contain arsenic. Long-term exposure to arsenic can cause cancer and skin lesions, cardiovascular disease, and diabetes, according to the World Health Organization (WHO). Exposure before birth or during early childhood can negatively affect cognitive development and lead to increased deaths in young adults.

Beryllium

Beryllium is a steel-grey metal. This heavy metal is present in or used to make televisions, calculators, computers, electrical components, tools, and telecommunication equipment.

Inhaling beryllium can cause chronic lung disease, such as beryllium sensitization, chronic beryllium disease (CBD), and lung cancer.

Cadmium

Cadmium is present in the earth’s crust, and is extracted through the production of copper, lead, zinc and other metals. This heavy metal may be present in children’s metal jewelry, batteries, pigments and plastics.

Short-term exposure from inhaling cadmium can cause coughing, chest pain, throat and nose irritation, while long-term inhalation exposure can lead to cancer, lung damage, kidney disease, and convulsions. Eating food or drinking water containing large amounts of cadmium can irritate the stomach or cause vomiting and diarrhea. Long-term exposure to cadmium can cause brittle bones.

Chromium

Chromium may be present in steel and metal alloys, chrome plating, textiles, dyes and pigments, leather and wood preservation, and copying machine toner. Exposure to chromium may lead to lung disease and cancer, and cause gastrointestinal, neurological, reproductive, or developmental effects.

Cobalt

Cobalt can cause lung problems, irritate the skin, and affect the thyroid gland. This heavy metal may be present in alloys, batteries, chemistry/crystal sets, drill bits and machine tools, magnets, tires, ceramics, paints, and dyes and pigments, such as cobalt blue.

Lead

Lead is present in children’s jewelry and toys, ceramics, lipstick, paint, and even candy. Exposure to lead can result in brain damage, nervous system damage, hearing problems, anemia, hypertension, decreased kidney function, male and female reproductive problems, and miscarriage. Lead exposure in children can lead to behavior and learning problems, lower IQ, hyperactivity, hearing problems, and anemia.

Mercury

A large number of products contain mercury, such as antiques, electronics and television sets, appliances, button cell batteries, paint, skin-lightening creams, jewelry, lamps and light bulbs, sporting equipment, and thermometers. This heavy metal can cause fetal developmental and neurological problems, and affect the kidneys, central nervous system, gastrointestinal tract, and respiratory system.

Nickel

Exposure to nickel can cause allergic reactions, lung disease, and cancer. This heavy metal may be present in coins and jewelry, nickel plating, ceramics and batteries.

Several factors can influence the toxicity of a heavy metal. The dose, route of exposure, and type of chemical can affect toxicity, for example, as can the age, gender, genetics, and nutritional status of the person exposed to them.

Many consumers demand products that contain very low levels or zero heavy metals. Manufacturers are now responding to consumer demand by reducing levels of heavy metals in the products they make and putting their products through testing to verify their efforts at reducing these toxic heavy metals from their products.

As a leader in Consumer Product Testing, Eurofins keeps our customers up to date on the latest regulations to ensure compliance. To learn more about our services, contact us today.

Hazardous Substance Restrictions at the State Level  

When it comes to controlling hazardous substances in the United States, individual states outpace the federal government.

The federal government’s Toxic Substances Control Act (TSCA) and its amendment, the Lautenberg Chemical Safety Act for the 21st Century Act (H.R. 2576 (2016)), directs the federal response to chemical safety and strengthens the Environmental Protection Agency’s ability to regulate chemicals.

A number of states have adopted their own chemical safety laws, which establish frameworks to categorize hazardous or potentially hazardous chemicals, fill in missing information about those chemicals, and restrict the use of the chemicals in those states.

To date, 32 states have passed laws regulating bisphenol A (BPA), cadmium, chemicals in flame retardants, and chemical safety. Many of the states are also passing regulations that move them towards “green chemistry,” which involves the creation of products and processes that do not generate hazardous substances. Four states have passed statutes permitting them to develop comprehensive chemical regulatory programs.

State Regulation of BPA in Consumer Products

BPA is a hardening agent found in a wide variety of plastic products, such as baby bottles, children’s drinking cups and “sippy” cups, and medical and dental devices. BPA is also used in coatings for food and beverage cans. Research shows a connection between BPA exposure to accelerated puberty, along with an increased risk for cancer, diabetes, and heart disease.

Out of concern regarding the potential effects of BPA exposure to children, the U.S. Food and Drug Administration (FDA) announced in July 2012 that it would prohibit BPA in children’s drinking cups and baby bottles. The FDA has not banned BPA use in other consumer products. Since 2009, 13 states and the District of Columbia have enacted BPA restrictions.

State Regulation of Flame Retardants in Consumer Products

Flame retardants in consumer products save lives, of course, but certain flame retardants chemicals may present environmental and human health effects. One group of flame retardant chemicals, polybrominated diphenylethers (PBDEs), is of special concern. Research shows that PBDEs, found in mattresses, furniture foam, wire insulation, consumer electronics, draperies and upholstery, accumulate in environment and living organisms. There is also evidence that associates exposure to PBDEs with liver toxicity, thyroid toxicity, and neurodevelopmental toxicity in humans.

States are focusing their attention on three types of PBDEs:

pentaBDE

octaBDE

decaBDE

Twelve states and the District of Columbia now regulate the presence of pentaBDE and octaBDE in some consumer products. Eight states and the District of Columbia have implemented regulations of decaBDEs, or have authorized research into this chemical. Five states require electronic manufacturers to notify them if their products exceed standard PBDE values set by the European Union. Minnesota also requires manufacturers make PBDE-free equipment, supplies and products available for purchase and use by the state.

Cadmium in Children’s Consumer Products

Some children’s products contain cadmium, a toxic metal that is associated with delayed brain development, kidney and bone damage, and cancer. Common childhood behaviors, such as biting, chewing, or sucking toys or other products, puts children at special risk. Six states have now enacted laws limiting the use of cadmium in children’s products.

States with Green Chemistry Statutes

To promote the use of less toxic chemicals, many states have adopted green chemistry laws. Depending on how the EPA deals with green chemistry compounds and the interpretation of state and federal laws, the revised TSCA law may or may not apply to state laws.

California’s Department of Toxic Substance Control identifies chemicals of concern and safer alternatives, while Connecticut established its Chemical Innovation Institute to address these chemicals. Michigan’s Department of Environmental Quality uses green chemistry to promote sustainable economic development.

Minnesota’s law promotes the use of green chemistry. Maryland and New York are working to put safer chemicals into schools for cleaning and maintenance. Oregon’s Department of Environmental Quality supports the development and use of safer alternatives to hazardous substances chemicals.

The restrictions on hazardous substances placed at the state level will have a positive effect on the environment and on human health.

As a leader in Consumer Product Testing, Eurofins keeps our customers up to date on the latest regulations to ensure compliance. To learn more about our services, contact us today.

The Impact of the California Cleaning Product Right to Know Act

 The State of California is making great strides toward implementing “right to know” regulations on cleaning products.

California Governor Jerry Brown signed the SB-258 Cleaning Product Right to Know Act of 2017 in October 2017. His signature made California the first state in the nation to have a cleaning products disclosure law. This new law, set to go into effect soon, requires manufacturers to list known hazardous chemicals in home and commercial cleaning products on the product label and online.

 

What the California Cleaning Product Right to Know Act Requires

 The California Cleaning Product Right to Know Act covers a wide variety of consumer products. The law applies to air care products to eliminate odors or freshen air, for example. It requires labeling for general cleaning products, such as soaps, laundry and dish detergents, floor cleaners, bathroom and tile cleaners, and carpet cleaners.

The regulation covers automotive products for washing, cleaning, polishing, waxing, and treating the exterior or interior surfaces of vehicles; it does not cover automotive paint or paint repair products.

The law requires that the disclosure of fragrance allergens present at greater than 100 parts per million (ppm), or 0.01%. The law is a bit different for disinfectants – manufacturers must list ingredients on the product website, but are exempt from labeling provisions.

Many products are exempt, including:

• Foods, drugs, and personal care items such as toothpaste, shampoo, hand soap and hand sanitizers
• Industrial products made exclusively for use in oil and gas production, heavy industry manufacturing, steel production, industrial water treatment, industrial textile maintenance, and food and beverage processing and packaging
• Trial samples not packaged for individual sale, retail or resale – these products must indicate that the product is not for sale or resale

 

Labels Must Disclose Intentionally Added Ingredients

 The law requires that the product label disclose each intentionally added ingredient, along with the ingredient’s Chemical Abstracts Service (CAS) number, included on specified chemical lists. These chemical lists include, but are not limited to:

• California’s Proposition 65 list
• EU list of substances of very high concern (SVHCs)
• S. EPA’s Integrated Risk Information System (IRIS) list of chemicals for which neurotoxicity is indicated
• International Agency for Research on Cancer (IARC) list of carcinogens
• Canadian Environmental Protection Act (CEPA) list of chemicals identified as toxic, persistent, and bioaccumulative

Manufacturers may list all intentionally added ingredients contained in their products, unless it is confidential business information.

The law imposes additional administrative requirements, such as requiring that the label include the manufacturer’s toll-free telephone number and website address. Lawmakers define manufacturers as the entity that makes the product and whose name appears on the label, or the entity for which the product is manufactured or that distributes the product as identified on the product’s label. In other words, the distributor may bear responsibility for listing ingredient information on their website and on the product label.

California is implementing the law in phases. Manufacturers of cleaning products must begin listing ingredient information on their websites on January 1, 2020. The product label must disclose information about ingredients on or after January 1, 2021. Regulators may deem a product acceptable after the compliance date if the label or website lists a manufacture date or manufacture date code. Manufacturers have until January 1, 2023, to list intentionally added ingredients covered by Proposition 65, a California law that protects drinking water from toxic substances that cause cancer and birth defects.

Products that do not comply with the act cannot be sold in California. The state’s Unfair Competition Law allows for the filing of lawsuits seeing civil penalties of up to $2500 per violation.

To prove compliance, many companies turn to testing, inspection and certification laboratories. Eurofins Consumer Product Testing can assess a product’s need for testing, provide customized services and technology, and help companies impacted by the California Cleaning Product Right to Know Act.

BPA Use and What Regulators Are Doing About It

BPA (bisphenol A) is an industrial chemical that manufacturers have used since to make polycarbonate plastics and resins since the 1960s. Manufacturers use BPA to create soft plastics, dental sealants, and thermal cash-register receipts. They also use BPA in the epoxy-resin linings present in metal food cans; the epoxy creates a barrier between the metal and the food, but it can also leach into the food and enter the human body.

Once inside the body, BPA may be an endocrine disruptor, which means it mimics hormones made by the body and therefore could have unintended and potentially far-reaching effects on those who come into physical contact with the chemical. BPA can cause a variety of reproductive disorders, including affecting egg maturation, early puberty, infertility, and erectile dysfunction. Exposure to BPA may also be associated with heart disease, type 2 diabetes, poor fetal brain development, breast and prostate cancer, and asthma. Infants and young children are particularly sensitive to the effects of BPA.

Human exposure to BPA is widespread, with most of the exposure coming from eating canned foods. In fact, Center for Disease Control and Prevention (CDC) scientists found BPA in the urine of nearly all of the participants who took part in the CDC’s National Health and Nutrition Examination Survey (NHANES) during 2003–2004. While finding a measurable amount of BPA in urine does not imply that the chemical may impart adverse health effects, it does indicate widespread exposure.

 

Regulation of BPA in the United States

Regulation of BPA is a patchwork of state and federal laws, many of which hinge on the amount of BPA in consumer products. The FDA maintains that the current levels of BPA in many products are below government standards and are therefore safe. Lawmakers and health professionals across the country disagree, and several states have now enacted laws and regulations to prohibit BPA in specific consumer products. Many of these laws focus on banning BPA in baby bottles and spill-proof cups, also known as “sippy cups,” because of the chemical’s potential for developmental harm in infants and small children.

States with laws restricting BPA in consumer products include:

• California
• Connecticut
• Delaware
• Maine
• Maryland
• Massachusetts
• Minnesota
• Nevada
• New York
• Vermont
• Washington
• Wisconsin
• District of Columbia

Each state has different requirements. 

California prohibits the manufacture, sale, or distribution of bottles or cups containing detectable levels of BPA above 0.1 parts per billion for products intended for use by children three years of age or younger. It requires manufacturers to replace BPA with the least toxic alternative.

Connecticut bans BPA in reusable food or beverage containers that contain BPA, and prohibits BPA in infant formula or baby food. Delaware law prohibits the sale of cups or bottles containing BPA in containers designed for use by children under the age of four. Illinois bans BPA in thermal paper; Chicago became the nation’s first city to ban BPA in baby bottles in 2009.

Maine law establishes BPA as a priority chemical, a designation that requires manufacturers to report products containing BPA. Maryland legislation prohibits infant formula in containers that contain .5 parts per billion of BPA. The Massachusetts Department of Public Health banned children’s reusable food or beverage containing BPA.

In 2009, Minnesota became the first state to ban BPA from baby bottles and sippy cups. Minnesota now bans BPA in food containers intended for use by infants and children, and prohibits manufacturers from replacing BPA with chemicals that may cause cancer, reproductive/developmental toxicity, or other systemic toxicity.

Nevada bans BPA in bottles, sippy cups, and formula and kids’ food. New York is different from other states in that it also prohibits the sale of pacifiers with BPA. The state is also unique in that its law allows manufacturers to label products as BPA-free. In addition to banning BPA in baby bottles and spill-proof cups, Vermont bans the chemical in reusable food or beverage containers, including sports bottles and thermoses.

Washington State bans BPA in sports bottles and in bottles, cups, and other empty food and drink containers intended for children under the age of 3 years. Wisconsin requires retailers that sells or offers children’s containers label their products as BPA-free. District of Columbia prohibits BPA in any empty containers intended to hold any food or beverage for use by a child under the age of 4 years.

Testing and labeling can help manufacturers comply with state regulations. Adequate testing and clear labeling can also help manufacturers and retailers build brand confidence in consumers who are worried about the negative health effects of BPA.

As a leader in Consumer Product Testing, Eurofins keeps our customers up to date on the latest regulations to ensure compliance. To learn more about our services, contact us today.

 

EU Compliance for Food Packaging Regulations

Food packaging carries out several essential tasks, including protecting food against contamination or damage and providing consumers with important information about the package’s contents. Advanced food packaging materials are microwaveable, reducing browning or other signs of aging, extend shelf life, and can even monitor the condition of the food inside. Unfortunately, some packaging may not be suitable for food as they can transfer unhealthy or even dangerous substances to the consumer. Like other nations intending to protect consumers, the European Union (EU) has enacted regulations guiding the food packaging industry.

The EU broadly defines foods packaging materials under the umbrella term “food contact materials,” which also includes other materials or machinery, such as coffee machines or food processers, that may come into contact with food under normal conditions.

EU’s Framework Regulation

Companies that supply food contact materials and food packaging must comply with EU’s food contact regulations. Several regulations control food packaging in the EU, but two regulations stand out: Regulation (EC) No. 1935/2004 and Regulations (EC) No. 2023/2006 on GMP.

Regulation (EC) No. 1935/2004

Regulation (EC) No. 1935/2004 requires materials that do not release harmful levels of their constituents into foods. The regulation requires materials that do not change the taste, odor or composition of food in an unacceptable way. It also requires that businesses involved in food packaging must establish a system that traces food contact materials (FCMs) at every step from production to distribution.

The regulation allows the EU to set specific measures pertaining to certain types of materials, such as plastics; following adoption of such measures, manufacturers using those materials must submit a written Declaration of Compliance (DoC). In the DoC, businesses must say that they comply with all applicable regulations, and provide supporting documentation and traceability through labeling and supply chain records.

The EU has already set several measures covering a number of materials. Companies using these materials for food packaging must file a DoC. These measures and materials include:

 

• Regulation (EU) No 10/2011 on plastic materials
• Regulation (EC) No 282/2008 on recycled plastic materials
• Regulation (EC) No 450/2009 on active and intelligent materials
• Directive 84/500/EEC for ceramics
• Directive 2007/42/EC for regenerated cellulose film

EU Member States may set their own national provisions for materials, such as coatings, adhesives, and paper, when the EU has not.

The regulation also requires labeling for materials and articles that are not yet in contact with food when introduced to the market. Labeling should bear the words “For food contact,” the glass/fork symbol, or other indication that the product meets guidelines for contact with food.

Regulation (EC) No. 2023/2006 on GMP

Ensuring that the food consumers receive is safe to eat is a complex undertaking – retailers must be confident that the food and food packaging supply line is compliant with safety regulations. Good manufacturing practice guidelines (GMP) are a quality assurance tool that assures retailers and consumers that their food’s packaging is safe. 

Regulation (EC) No. 2023/2006 on GMP says that manufacturers must create food contact materials (FCMs) in compliance with good manufacturing practice guidelines. The regulation ensures that the specifications for these materials conform to legislation. Specifically, the business’s premises must be fit for food packaging and staff must be knowledgeable about critical stages in production.

Companies must document quality assurance and quality control systems they maintain on the premises; documentation must provide traceable information to support compliance claims. Documentation must include information about material compositions Declarations of Conformity, test reports, and operative documents.

To prove compliance with EU’s food packaging regulations, many companies turn to testing, inspection and certification laboratories. Eurofins Consumer Product Testing can assess a product’s need for testing, provide customized services and technology, and help companies who use food packaging comply with EU’s regulation. Downloadable PDF.

How Regulation and Consumer Safety Concerns Will Impact the Rapidly Growing CBD Market

The laws on cannabis and cannabis products used to be clear – they were illegal to sell, possess or use. Today, however, cultural views toward cannabis and the laws governing its sale are changing. Many states are legalizing the medical and recreational use of marijuana, despite the fact that cannabis is still illegal at the federal level. Downloadable PDF.

How Increased FDA Involvement Could Impact the Cosmetics Industry

The U.S. Food and Drug Administration (FDA) has largely avoided strict regulation over the cosmetics industry for more than a century. Now, over rising health concerns over the safety and manufacturing practices of some cosmetics, the FDA is increasing its involvement in the industry. Downloadable PDF.

Responding to Consumer Sustainability Concerns with Reusable Packaging

Threatened by mounting trash, pollution and other environmental concerns, today’s consumers are increasingly interested in sustainability, particularly in the products they buy. Reusable packaging will likely play an important role in making products environmentally friendly and attractive to customers. Downloadable PDF.

Eurofins Microplastic in Drinkingwater study (MPDW)

There is a global market interest and concern regarding microplastics (MP) and their impacts in the environment. Eurofins, as one of the leading laboratories all over the world, together with the laboratory in Bergen, felt compelled to improve the nowadays knowledge by mapping microplastic levels in different countries. To achieve this purpose we needed a methodology that could quantify the content of microplastics and participants all over the world willing to send samples to our laboratory. Global Report