INK SAFETY PORTAL

Substances of Interest

Substances having chronic adverse effects for human health and the environment such as Endocrine Disruptors (ED), Persistent, Bioaccumulative and Toxic (PBT) and very Persistent and very Bioaccumulative (vPvB) and Per and polyfluorinated alkyl substances (PFAS) were identified in numerous food contact materials. Current scientific studies have shown that these chemicals do migrate out of food packaging under realistic use conditions, making them highly relevant for human exposure. The potential impact due to the exposure of these chemicals is linked to serious health effects ranging from endocrine disruption, cancer, reproductive dysfunction, birth defects, disturbance of the immune system, damage to the liver and nervous system. There is a worldwide growing concern about the negative human health and environmental impacts caused by these class of chemicals.

Please read our ePapers to get a deeper introduction about these substances of concern.

EDC’s

The following ePaper provides a quick overview of endocrine disruptors, their regulatory framework and Siegwerk position on these substances.

Endocrine Disrupting Chemicals
(EDC’s)

An endocrine disruptor is an “exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse effects in an intact organism, or its progeny, or (sub)populations” while “a potential endocrine disrupter is an exogenous substance or mixture that possesses properties that might be expected to lead to endocrine disruption in an intact organism, or its progeny, or (sub)populations” (IPCS 2002; OECD 2018). The harmful impacts of endocrine disrupting chemicals (EDC’s) on health and the environment has been known for more than 20 years. EDC’s can cause decreased fertility, hormone-related cancers, behavioral changes, adverse effects on the immune systems, and metabolic disorders.

There are several mechanisms by which a chemical disrupts hormone action. Endocrine disruptors can:

  • mimic the action of a natural hormone
  • block a hormone from binding to its receptor
  • disrupt the production/degradation or regulation of hormones or their receptors
  • disrupt the transport of a hormone within the organism

A wide range of substances, both natural and man-made, may cause endocrine disruption. Many chemicals like bisphenols, phthalates, parabens, brominated and perfluorinated compounds, alkylphenols, triclosan found in the consumer products and their packaging materials are suspected of having endocrine disrupting properties to human health and environment.

EDC European Regulations

There is a worldwide growing concern about the negative human health and environmental impacts caused by endocrine disruptors. Endocrine disruptors in chemical products are regulated in the EU through a number of legal instruments such as Regulation on the Registration, Evaluation and Assessment of Chemicals (REACH), Plant Protection Product Regulation (EC) No 1107/2009 and Commission Regulation (EU) 2018/605, Biocidal Product Regulation (EU) No 528/2012, Commission Delegated Regulation (EU) 2017/2100 and Cosmetics Products Regulation (EC) No 1223/2009. Under REACH, endocrine disruptors are identified as Substances of Very High Concern (SVHC) alongside chemicals known to cause cancer, mutations and toxicity to reproduction (CMR). The European Commission (EC) has introduced specific legislative obligations aimed at phasing out endocrine disruptors from consumer products including food contact materials. In October 2020, EC has adopted its “Chemicals Strategy for Sustainability (CSS)”, a roadmap to achieve “a toxic-free environment”, as established in the “zero pollution ambition” of the European Green Deal. In the CSS framework, “generic approach to risk management (GRA)” is extended to ensure that consumer products including food contact materials do not contain chemicals that cause endocrine disruption. The aim is to ban endocrine disrupting chemicals in consumer products and ultimately replace them with safer alternatives.

Further, EC has established a legally binding hazard identification of endocrine disruptors and exclusive hazard categories shall be introduced in the classification, labelling and packaging of substances and mixtures (CLP) regulation, a cross-cutting regulation that rules on the hazardous nature of chemicals and imposes specific labelling in Europe. Endocrine disrupting hazard classification for human health and environment for substances and mixtures shall be allocated to one of two categories based on strength of evidence and additional considerations in a weight of evidence determination, i.e., Category 1 for known or presumed endocrine disruptors and Category 2 for suspected endocrine disruptors.


Read also ePaper CLP Classification Criteria for EDC’s

EDC Global Regulations

There is widespread focus in advancing the screening of EDC’s globally as well. Several regulatory frameworks like Endocrine Disruption Screening Program (EDSP) by US EPA; Canadian Environmental Protection Act (CEPA) by Canada; Australian Industrial Chemicals Introduction Scheme (AICIS) by Australia; Strategic Program on Environmental Endocrine Disruptors (SPEED) and Extended Tasks on Endocrine Disruption (EXTEND) by Japan implement requirements to assess the endocrine potential of the chemicals.

 

Siegwerk position on EDC’s

Siegwerk is committed to ink safety and its efforts to supply the safest inks go far beyond legal requirements. Siegwerk act on precautionary principles and proactively replace any chemicals signaling endocrine disruption activity and (or) proven to be an endocrine disruptor in the ongoing assessments of EC or any other prominent regulatory bodies across the globe with safer alternatives.

 

PBT/vPvB

The following ePaper provides a quick overview of Persistent, Bioaccumulative and Toxic (PBT) and very Persistent and very Bioaccumulative (vPvB) substances, their regulatory framework and Siegwerk position on these substances.

Persistent, Bioaccumulative and Toxic or very Persistent and very Bioaccumulative Substances
(PBT/vPvB)

Persistent, Bioaccumulative and Toxic (PBT) and very Persistent and very Bioaccumulative (vPvB) substances are a class of compounds that have high resistance to degradation, bioaccumulate in humans and other species and exhibit high toxicity. These substances typically accumulate in fatty tissues and slowly metabolize, often increasing in concentration within the food chain and pose serious concerns for human and environmental health. The effects of these substances range from endocrine disruption, cancer, reproductive dysfunction, birth defects, disturbance of the immune system, damage to the liver and nervous system.

Due to their physico-chemical characteristics, PBT/vPvB substances do not degrade near emission sources but may be gradually transported into distant areas, hence is neither possible to accurately predict the environmental fate of these substances nor the kind of adverse effects that could arise over long periods of time. A ‘safe’ concentration in the environment cannot be established using the currently available scientific methods. Another concern with PBT/vPvB substances is that even if no adverse effects can be demonstrated under laboratory testing conditions, long-term effects might be possible, as high but unpredictable levels may be reached in humans or the environment over extended time periods.

A wide range of substances exist, both natural and man-made, that may exhibit PBT/vPvB properties. Many industrial chemicals like Per and polyfluorinated alkyl substances (PFAS), bisphenols, Hexachlorobenzenes (HCBs) and Polychlorinated biphenyls (PCBs), some pesticides and heavy metals are suspected of PBT/vPvB properties.

PBT/vPvB Regulations

There is a worldwide growing concern about the negative human health and environmental impacts caused by PBT/vPvB substances. These substances are regulated in the EU through a number of legal instruments such as Regulation on the Registration, Evaluation and Assessment of Chemicals (REACH) (Regulation (EC) No 1907/2006, Plant Protection Product Regulation (EC) No 1107/2009, Biocidal Product Regulation (EU) No 528/2012, Veterinary Medicinal Products Regulation (Directive 2001/82/EC) and Human Medicinal Products Regulation (Directive 2001/83/EC). Under REACH, PBT/vPvB substances are identified as Substances of Very High Concern (SVHC) and aim for their substitution with suitable technically and economically viable alternatives. The European Commission (EC) has introduced specific legislative obligations aimed at phasing out these substances from the consumer products including food contact materials. In October 2020, EC has adopted its “Chemicals Strategy for Sustainability (CSS)”, a roadmap to achieve “a toxic-free environment”, as established in the “zero pollution ambition” of the European Green Deal. In the CSS framework, ‘generic approach to risk management (GRA)’ is extended to ensure that consumer products including food contact materials do not contain PBT/vPvB substances. The aim is to ban these substances in consumer products and ultimately replace them with safer alternatives.

Furthermore, EC has established a legally binding hazard identification for PBT/vPvB substances and exclusive hazard categories shall be introduced in the classification, labelling and packaging of substances and mixtures (CLP) regulation, a cross-cutting regulation that rules on the hazardous nature of chemicals and imposes specific labelling in Europe.

Additionally international organizations like the United Nations (UN) and different jurisdictions in USA, Canada and Japan have set up similar regulatory systems to screen and reduce the exposure of the substances with PBT or vPvB properties.


Read also ePaper CLP Classification Criteria for PBT/vPvB

 

Do Siegwerk inks contain PBT/vPvB substances?

In the manufacture of all products supplied by Siegwerk, substances concluded as PBT/vPvB by ECHA, or raw materials containing these substances are not used as intentionally added components. However, the presence of very minute but analytically detectable traces of these substances in the product originating from raw material impurities, or as contaminants, cannot be fully excluded. We proactively monitor and/or retrieve supplier data on impurities in raw materials likely to contain traces of these substances and restrict them, if any, far below 0.1% in our printing inks.

 

PFAS

What are PFAS and how do they affect us and our health and environment? Read our ePaper and learn more about PFAS and Siegwerk commitment for the non-use of these chemicals in their printing inks.

Per and PolyFluorinated Alkyl Substances
(PFAS)

Per and polyfluorinated alkyl substances (PFAS), are a family of over 4700 synthetic chemicals that have been produced since 1940s. They are used in a broad range of consumer products and industrial applications, ranging from food packaging, cosmetics, clothing, non-stick coatings on pans, electronics, lubricants and firefighting foams. In food packaging materials they were used in grease-resistant paper, fast food containers/wrappers, pizza boxes and candy wrappers to keep the food sticking away from the packaging. Migration of PFAS into the food from certain types of food packaging was reported in the scientific literature.

PFAS are also known as the ‘forever chemicals’ because they are extremely persistent and do not break down easily in the environment. They are considered to be highly persistent (P), mobile (M), bioaccumulative (B) and toxic (T). PFAS molecules have a chain of linked carbon and fluorine atoms. Because of the strong carbon-fluorine bond, these chemicals are extremely resistant for degradation in the natural environment. The half-lives of some of the PFAS polymers were estimated to be >1000 years in soil. PFAS have a high water solubility and are extremely mobile in the environment, therefore they are easily transported over long distances away from the source of their release. Many PFAS are found in the blood of people and animals all over the world. PFAS tend to accumulate in protein rich compartments like blood, liver, kidney, bones and breast milk. They are slowly eliminated, with a half-life in blood up to 8.5 years for long-chain PFAS and up to 26 days for short-chain PFAS. Current scientific studies have shown that exposure to certain PFAS in the environment may be linked to serious health effects in humans and animals. Some PFAS are found to induce carcinogenic, reproductive, developmental and endocrine related health effects in humans and animals.

PFAS Global Regulations

Considering the magnitude of environmental contamination and resulting severe health effects to humans and animals, there is a worldwide growing concern about PFAS. The European Commission (EC) in its “Chemicals Strategy for Sustainability (CSS)”, a roadmap to achieve “a toxic-free environment”, as established in the “zero pollution ambition” of the European Green Deal has proposed a comprehensive set of actions to address the use of and contamination with PFAS. The aim is to phase out PFAS in the EU, unless it is proven essential for society. FDA regulates PFAS used in food contact applications and the market phase out of certain PFAS having potential safety concerns by conducting rigorous review of scientific data. Similar efforts to phase out certain PFAS from commerce and reduce the likelihood of their exposure were implemented by various regulatory agencies across the globe including Australia, China, Japan, New Zealand and UK.

 

Siegwerk position on PFAS

In the manufacture of all products supplied by Siegwerk, PFAS, especially those which are considered to be of concern such as Perfluorooctane sulfonates (PFOS) and Perfluorocarboxylic acids (PFCA) and their salts, including raw materials which may contain these PFAS are not used as intentionally added ingredients. However, the presence of potential traces of these substances in Siegwerk products originating from raw material impurities or as contaminants cannot be excluded. We proactively monitor and/or retrieve supplier data on impurities in raw materials likely to contain traces of toxicological and ecotoxicological concern. We can assure you that, according to the present scientific knowledge, potential traces of PFAS of concern in our products, if any, are well below 0.1%.

 

CLP Classification

 

CLP Classification Criteria for Endocrine Disrupting Chemicals

The proposed CLP classification criteria for endocrine disruptors for human health and environment can be found in the following ePaper.

CLP Classification Criteria for EDC’s

Classification criteria for Category 1 – Known or presumed endocrine disruptors

The classification in Category 1 shall be largely based on evidence from animal data. Such data shall provide the proof that the substance meets all the following criteria:

(a) endocrine activity;

(b) an adverse effect in an intact organism or its offspring and future generations;

(c) a biologically plausible link between the endocrine activity and the adverse effect.

However, if there are doubts about the relevance of the endocrine disrupting adverse effects for the population or subpopulation level, classification in Category 2 may be more appropriate.

Classification criteria for Category 2 – Suspected endocrine disruptors

The classification in Category 2 shall be largely based on evidence from animal data. A substance shall be classified in Category 2 when all the following criteria are met:

(a) there is evidence of an endocrine activity and an adverse effect in an intact organism or its offspring and future generations;

(b) the evidence referred to in point (a) is not sufficiently convincing to classify the substance in Category 1;

(c) there is evidence of a plausible biological link between the endocrine activity and the adverse effect.

If there is evidence conclusively demonstrating that the adverse effects identified are not relevant at the population or subpopulation level, the substance may not necessarily be considered an endocrine disruptor for the environment.

The concentration limits introduced to endocrine disruptors are in line with current CMR substances. A mixture shall be classified as an endocrine disruptor for human health (or the environment) when at least one component is present which has been classified as a Category 1 or 2 ED for human health (or environment) at or above the appropriate generic concentration limit as shown below:


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CLP Classification Criteria for PBT/vPvB

The proposed CLP classification criteria for PBT/vPvB substances can be found in the following ePaper.

CLP Classification Criteria for PBT/vPvB

Classification criteria for PBT


A substance is a PBT when it meets all of the following criteria:


1. Persistence

A substance fulfils the persistence criterion (P) when any of the following conditions is met:

(a) the degradation half-life in marine water is higher than 60 days;

(b) the degradation half-life in fresh or estuarine water is higher than 40 days;

(c) the degradation half-life in marine sediment is higher than 180 days;

(d) the degradation half-life in fresh or estuarine water sediment is higher than 120 days;

(e) the degradation half-life in soil is higher than 120 days.


2. Bioaccumulation

A substance fulfils the bioaccumulation criterion (B) when:

(a) the bio-concentration factor (BCF) in aquatic species is higher than 2000.


3. Toxicity

A substance fulfils the toxicity criterion (T) in any of the following situations:

(a) the long-term no-observed effect concentration (NOEC) or EC10 for marine or freshwater organisms is less than 0,01 mg/l;

(b) the substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B, or 2) according to Regulation EC No 1272/2008;

(c) there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification: specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008;

(d) the substance meets the criteria for classification as endocrine disruptor (Category 1) for humans or the environment according to Regulation EC No 1272/2008.

 

Classification criteria for vPvB


A substance that fulfils the criteria below is a vPvB substance:


1. Persistence

A substance shall be considered to fulfil the ‘very persistent’ criterion (vP) where any of the following conditions is met:

(a) the degradation half-life in marine, fresh or estuarine water is higher than 60 days;

(b) the degradation half-life in marine, fresh or estuarine water sediment is higher than 180 days;

(c) the degradation half-life in soil is higher than 180 days.


2. Bioaccumulation

A substance shall be considered to fulfil the ‘very bioaccumulative’ criterion (vB):

(a) the bio-concentration factor in aquatic species is higher than 5000.

 

Classification criteria for mixtures


A mixture shall be classified respectively as a PBT or vPvB when at least one component contained in the mixture has been classified respectively as a PBT or vPvB and is present at or above 0,1% (weight/weight).

 

Siegwerk Product Safety Responsibility

Siegwerk, being a global leading manufacturer of high-performance printing inks is fully committed to product safety, human health and environment. Our efforts to manufacture the safest inks go far beyond legal requirements. We are committed to proactively identify and phase out these toxic substances and ensure that all chemicals used in our printing inks are safe and sustainable.